STUDY. Phase 1/2 Pilot Study of Methotrexate-Laurocapram Topical Gel for the Treatment of Patients With Early-Stage Mycosis Fungoides
|
|
- Marilynn Anderson
- 6 years ago
- Views:
Transcription
1 STUDY Phase 1/2 Pilot Study of Methotrexate-Laurocapram Topical Gel for the Treatment of Patients With Early-Stage Mycosis Fungoides Marie-France Demierre, MD, FRCPC; Luc Vachon, PhD; Vincent Ho, MD; Lynda Sutton, BS; Allen Cato, MD, PhD; Brian Leyland-Jones, MD, FRCPC Objectives: To assess the safety and tolerability of a topical gel formulation combining methotrexate and laurocapram and to obtain preliminary information on the therapeutic potential of methotrexate-laurocapram in patients with early-stage mycosis fungoides (stage IA or IB). Design: An open-label, phase 1/2 pilot study. Setting: Two academic referral centers. Patients: Ten patients 18 years or older with histologically confirmed stage IA or IB mycosis fungoides. Intervention: The gel formulation of methotrexatelaurocapram was applied to the total body surface, excluding genital, perianal areas, nipples, face, and skin under the breasts, on an every-other-day basis for 24 consecutive weeks. Main Outcome Measures: The safety of methotrexatelaurocapram was assessed in this study by reviewing adverse events and laboratory data. Efficacy outcomes included changes in lesion condition and severity assessments, reduction in area of sample lesions, and the investigator s global evaluation. Results: Adverse events consisted of skin reactions of mild severity. No clinically significant laboratory abnormalities were observed. Based on the investigator s global evaluation at the end of the treatment phase (week 24), 7 (78%) of 9 patients demonstrated a slight-tomoderate response to treatment with methotrexatelaurocapram. Statistical significance (P=.049) was reached for induration and pruritus, a trend (P=.10) was observed for erythema, and no change was found for scaling (P=.37). Conclusions: These findings indicate that the topical administration of methotrexate-laurocapram is safe and in general well tolerated. This treatment may represent a new therapeutic potential for patients with mycosis fungoides. Arch Dermatol. 2003;139: From the Skin Oncology Program, Boston Medical Center, Boston, Mass (Dr Demierre); Cato Research Canada, St-Laurent, Quebec (Dr Vachon); Skin Care Center, Vancouver, British Columbia (Dr Ho); Durham Pharmaceuticals LLC, Durham, NC (Ms Sutton and Dr Cato); and McGill University, St Mary s Hospital, Montreal, Quebec (Dr Leyland-Jones). The authors have no relevant financial interest in this article. MYCOSIS fungoides (MF) is the most common form of cutaneous T-cell lymphoma (CTCL). 1 Mycosis fungoides is predominantly an indolent disease with 5-year disease-specific survival rates of 100% and 80%, respectively, for individuals with either limited skin involvement or skin tumors. 2 To date, no therapies for MF have demonstrated a survival advantage. 3,4 Thus, skin-directed therapies remain the first line of therapy in patients with earlystage MF (skin limited). Currently, these therapies include topical steroids, topical chemotherapy (topical carmustine and nitrogen mustard), topical retinoids, phototherapy, and local radiation. Although oral or parenteral methotrexate is approved by the Food and Drug Administration for the treatment of advanced MF, this agent has shown efficacy in treating erythrodermic MF, 5 and oral methotrexate has been used off-label for resistant patch or plaque MF and tumor stage MF. However, its systemic toxicity potential (gastrointestinal tract, bone marrow, lungs, kidneys, liver, and immune system) has precluded its use in patients with earlystage MF. No topical formulations of methotrexate are currently commercially available for clinical use. Topical therapy of earlystage MF with the existing oral or parenteral formulations of methotrexate is ineffective because of the inability of methotrexate to penetrate the stratum corneum from aqueous solutions. 6 The development of a topical formulation of methotrexate with enhanced dermal penetration characteristics would hence provide an additional effective therapy for patients with early-stage MF, a population for whom oral or intravenous methotrexate is currently not indicated for treatment. 624
2 Methotrexate-laurocapram is a topical hydrophilic gel formulation of methotrexate (1% wt/wt) with the penetration enhancer laurocapram (Azone). Laurocapram is a lipophilic compound initially developed by Whitby Research (Richmond, Va) and now manufactured by Durham Pharmaceuticals (Durham, NC) that has been shown to enhance percutaneous absorption of a wide variety of pharmaceutical compounds Results obtained in patients with psoriasis indicated that the topical application of methotrexate-laurocapram was safe, was well tolerated, and led to an improvement of the disease status in a significant proportion of patients Preliminary results from a pilot study in 4 patients with earlystage MF (stage IA or IB) indicated that methotrexatelaurocapram was both safe and well tolerated, 17 and 2 patients had a moderate response with a 50% to 99% disappearance of measurable and assessable disease. We present the results of a phase 1/2 study in 10 patients with early-stage MF who were administered a topical formulation of methotrexate-laurocapram every second day for 24 consecutive weeks. METHODS The primary objective of this open-label, phase 1/2 study was to evaluate the safety and tolerability of the topical administration of methotrexate-laurocapram in patients with stages IA and IB plaque CTCL. The secondary objectives were to evaluate the efficacy of topical methotrexate-laurocapram in this patient population and to obtain preliminary information on the systemic absorption of methotrexate following topical administration of methotrexate-laurocapram. PATIENT POPULATION To be enrolled in the study, patients with histologically confirmed stage IA or IB CTCL 18 had to be 18 years or older, be in good general health, and have liver transaminase levels less than twice the upper limit of the normal range, serum creatinine levels less than 2.0 mg/dl (176.8 µmol/l), hemoglobin level greater than 11 g/dl, a white blood cell count greater than 4000/µL, an absolute neutrophil count greater than 2000/µL, and platelet counts greater than /µL. Patients with stage II or higher CTCL, those with a history of intolerance to methotrexate or related drugs, or those currently undergoing treatment with sulfonamides and/or trimethoprim, phenytoin, sulfonylureas, phenylbutazone, or systemic steroids were excluded. Also excluded were patients with active hepatitis or active cytomegalovirus infection, systemic cutaneous bacterial infection or viral disease, or any other active malignant neoplastic disorder. Pregnant or lactating women or individuals of childbearing potential unwilling to practice adequate contraception were not eligible. A washout period was required before study entry as follows: 6 weeks for topical mechlorethamine hydrochloride, topical steroids, topical carmustine, phototherapy, and oral methotrexate or 12 weeks for electron beam therapy. The study protocol was approved by the local institutional review boards, and informed consent was obtained for all patients before the initiation of the study. TREATMENT PLAN The gel formulation of methotrexate-laurocapram (provided in 2-oz jars containing 30 g of product) was applied at daily doses of either 12.5 or 25 g/m 2 to the total body surface, excluding genital, perianal areas, nipples, face, and skin under the breasts, on an every-other-day basis for 24 consecutive weeks. Based on the original design of this pilot study, the first patient, who was enrolled at the University of British Columbia, Vancouver, also received daily topical administration of nitrogen mustard on half the body, whereas the other half of the body was treated with 25 g/m 2 of methotrexate-laurocapram; the results obtained with nitrogen mustard in this particular patient will be the subject of a separate report. To comply with interactions with regulatory authorities, the protocol was then modified to include patients treated with methotrexate-laurocapram at Boston Medical Center only (Boston, Mass). SAFETY ASSESSMENTS The following safety assessments were conducted at screening, baseline, and every 4 weeks during the study: routine laboratory evaluations (hematologic and clinical chemical analysis) and pregnancy test. Urinalysis was performed at screening, baseline, week 12, and week 26. Adverse reporting and a physical examination were conducted every 2 weeks during the first month of the study and every 4 weeks thereafter. EFFICACY ASSESSMENTS The evaluation of therapeutic response to treatment included the body surface area involvement of lesions and the assessment of severity in 3 test lesions selected before the initiation of treatment; these outcomes were evaluated at baseline, weeks 12 and 24, and 2 weeks following the termination of treatment (week 26). Changes in severity outcomes (eg, induration, erythema, scaling, and pruritus) relative to baseline were graded as worsened ( 2), no change ( 1 and 1), or improved ( 2) for each test lesion and summed across the lesions for each patient. Photographic documentation was obtained at baseline, week 12, and week 24. Photographs were used to assess both the body surface area and severity (induration, erythema, scaling). Attempts were made to control both lighting and technical elements, but this was not possible for all patients. All photographs were evaluated by the site investigators (M.-F.D., V.H.) and were therefore not reviewed in a blinded fashion. At each enrolling site, the same investigator(s) scored the subjects throughout the study. Responses were defined as follows: progressive disease, defined as new lesions developing; no response, defined as stabilization of existing lesions with no new lesions developing; slight response, defined as less than 50% disappearance of measurable and evaluable lesions; moderate response, defined as 50% to 74% disappearance of measurable and evaluable lesions; marked response, defined as 75% to 99% disappearance of measurable and evaluable lesions; and complete response, defined as disease that is 100% clinically cleared. METHOTREXATE SERUM LEVELS Blood samples were drawn at screening, baseline, and 24 to 48 hours following the topical administration of methotrexatelaurocapram every 4 weeks during the study and the posttreatment follow-up visit (week 26). Samples were analyzed at the Department of Biochemistry of Maisonneuve-Rosemont Hospital, Montreal, Quebec, using the TDX Methotrexate system (Abbott Laboratories Ltd, Diagnostics Division, Mississauga, Ontario). The lowest limit of detection for the methotrexate assay was 0.05 µmol/l. STATISTICAL ANALYSIS SAS statistical software for Windows (SAS Institute Inc, Cary, NC) was used to performed the 2 and Maxwell-Stuart homogeneity tests. 625
3 RESULTS Key demographic information on the study population is summarized in Table 1. Seven of these patients had previously received other treatment for MF, including topical therapies (steroids, carmustine, nitrogen mustard), psoralen UV-A, oral methotrexate, and sunlight, with responses varying from progressive lesions to slight improvement. Of 10 patients with early-stage CTCL (stage IA or IB) who were enrolled in the study, 9 completed the study, and 1 discontinued participation at week 10 of the treatment phase. Five patients were administered only the dose of 12.5 g/m 2, 2 applied both 12.5 g/m 2 for 8 and 20 weeks, respectively, and 25 g/m 2, and 2 were treated only with the dose of 25 g/m 2 for the entire study. A total of 22 adverse events were reported in 9 of the 10 patients enrolled in the study. These adverse events were Table 1. Demographic Information and Previous Therapies Variable Men (n=7) Women (n=3) Age, mean ± SD (range), y 48 ± 19 (22-78) 53 ± 18 (37-73) Ethnicity White 4 2 African American 1 1 Hispanic 2 0 Previous therapies Topical steroids 3 3 Nitrogen mustard 0 2 Topical carmustine 1 0 Psoralen UV-A 1 1 Oral methotrexate 1 0 Sunlight 1 0 grade 1 or 2 according to the National Cancer Institute s Common Toxicity Criteria and involved the following body systems: skin and appendages (n=8), respiratory system (n=5), and hemic and lymphatic systems (n=2). Ten of these adverse events, reported by 7 patients (70%), were considered to be related to methotrexate-laurocapram according to the investigator (M.-F.D., V.H.). These adverse events included pruritus (n=6), rash (n=2), dry skin (n=1), and contact dermatitis (n=1). One patient who discontinued treatment at week 10 had experienced moderate pruritus and a skin eruption consistent with contact dermatitis. Among the 5 patients who applied 12.5 g/m 2 of methotrexate-laurocapram, 3 interrupted the gel application (1 patient for 4 days, 1 patient for 9 days, and 2 patients for 12 days) because of skin peeling and irritation, personal reasons, and skin eruption, respectively. Thereafter, 2 of these patients reapplied methotrexatelaurocapram on every third day instead of every second day. No clinically significant abnormalities in vital signs or urine outcomes were observed during the study. Changes in clinical chemical and hematologic analysis results were reported in 9 and 8 patients, respectively. None of these changes were reported by the investigators (M.-F.D., V.H.) as being clinically significant in the context of the study. According to the investigator s global evaluation that was conducted at the end of the treatment phase (week 24), 3 patients (33%) had a moderate response, 4 (44%) had a slight response, and 2 (22%) had no response to treatment (Table 2), for a total of 7 (78%) who displayed a slight-to-moderate response to treatment of the 9 patients who completed the study. The Figure shows 1 patient s lesion at baseline and 24 weeks. Two weeks following treatment termination (week 26), 1 patient (11%) had a moderate response to treatment with Table 2. Summary of Investigator s Global Evaluation of Methotrexate-Laurocapram Therapy Relative to Baseline Patient s Response to Therapy, No. (%) Visit Marked Moderate Slight None Progressive Disease Week 4 (n = 10) 0 (0) 4 (40) 3 (30) 3 (30) 0 (0) Week 12 (n = 8) 2 (25) 4 (50) 1 (13) 1 (13) 0 (0) Week 24 (n = 9) 0 (0) 3 (33) 4 (44) 2 (22) 0 (0) Week 26 (n = 9) 0 (0) 1 (11) 7 (78) 0 (0) 1 (11) A B Erythematous plaque of patient 9 at baseline visit (A) and week 24 (B). 626
4 Table 3. Summary of Collapse Changes in Methotrexate-Laurocapram Treated Test Lesion Severity Outcomes Relative to Baseline Condition* Lesion Severity Outcomes Visit Degree of Severity Induration Erythema Scaling Pruritus Week 8 (n = 10) Deterioration No change Improvement P value Week 16 (n = 9) Deterioration No change Improvement P value P value Week 24 (n = 9) Deterioration No change Improvement P value P value Week 26 (n = 8) Deterioration No change Improvement P value P value *Data are number of patients unless otherwise indicated. P value obtained using a 2 goodness-of-fit test. P value obtained using a Maxwell-Stuart test. Comparison of a given proportion with the one obtained at the previous visit. methotrexate-laurocapram, 7 (78%) had a slight response, and 1 (11%) had progressive disease, for a total of 8 (89%) who had a slight-to-moderate response. Table 3 outlines the changes in severity outcomes of test lesions compared with baseline based on the collapsed categories derived from the sum of the lesion grading score. At the end of the treatment period, an improvement in induration, erythema, scaling, and pruritus was reported in 6, 7, 4, and 3 patients, respectively; these changes reached statistical significance for induration and pruritus, whereas a trend (P=.10) was observed for erythema. Two weeks following the completion of the treatment, the relative proportion of patients for whom an improvement was observed compared with baseline remained similar for both induration and erythema, whereas the number of patients for whom an improvement had been observed at week 24 decreased from 4 (44%) to 1 (13%) for scaling and from 3 (33%) to 1 (13%) for pruritus. The mean total surface area of the test lesions varied from 5.6 to 165 cm 2 among the individual patients at baseline. On the whole, this outcome was not statistically different at the end of the treatment (P=.38). At the end of treatment, 5 patients displayed changes of less than 25% compared with baseline, 3 had decreases of 26%, 33%, and 37%, respectively, and 1 had a 32% increase. Similarly, the total body surface area involvement, which also varied substantially among the individual patients, was comparable at baseline (23%) and the end of the treatment (18%). On an individual basis, changes of less than 25% were observed during the study in 6 patients, whereas decreases of 40% and 50% were observed in 2 patients and an increase of 2% to 10% of BSA involvement was observed in 1 patient (data not shown). The serum concentration of methotrexate, as measured 24 to 48 hours following the topical application of methotrexatelaurocapram, was under the lowest limit of detection, ranging between 0.01 and 0.03 µmol/l in all samples analyzed, regardless of the dose received and the interval between dosing and sample collection. COMMENT The results of this phase 1/2 pilot study, conducted in 10 patients with early-stage MF disease, indicate that the topical application of 12.5 or 25 g/m 2 of methotrexatelaurocapram once every other day for 24 consecutive weeks led to minimal systemic exposure to methotrexate, was well-tolerated, did not generate changes in the safety assessments indicative of the toxicity usually associated with methotrexate, and produced a slight-tomoderate response in 7 (78%) of 9 patients, based on the investigator s global evaluation. Except for unpublished data obtained in a pilot study of 4 patients, 17 this is the first published study to our knowledge demonstrating that topical methotrexate is safe and could potentially be efficacious in treating patients with early-stage CTCL. Since the improvement in the severity of the lesions was accompanied with positive changes in either the surface area or body surface area involvement in some but not all patients, further investigation would be required to determine the optimal drug concentration, frequency of administration, and duration of treatment. Most patients had grade 1 toxic effects, and only 1 patient discontinued the study because of contact dermatitis. Because this patient had also developed an allergic contact dermatitis to topical nitrogen mustard, the possibility that the patient had other topical allergies cannot be excluded. Skin-directed therapies have been the first-line treatments for early-stage disease. Current topical options in- 627
5 clude highly potent topical steroids, topical carmustine or nitrogen mustard, and topical retinoids (1% bexarotene retinoid gel). High-potency steroids have been shown to be effective, with a response rate of 94% in stage T1 disease (complete response in 63%). 19 Topical nitrogen mustard, which is the standard to which other therapies have been compared, displays response rates of approximately 88%, with a 51% complete response in stage T1 disease. 20 However, its use has been limited by the frequency of allergic contact dermatitis, which ranges from 30% to 80%. 21 Topical carmustine has comparable efficacy to topical nitrogen mustard and has a lower frequency of contact dermatitis. 22 However, persistent telangiectasias at treated sites may be seen, and 3% to 5% can develop mild leukopenia with carmustine solution or ointment. 23 Although 1% bexarotene gel has shown an overall response rate of 26% to 63% (complete response in 8%-21%) in patients with refractory stage IA-IIA CTCL, a skin eruption occurred in 56% of patients and pruritus in 18%. 24,25 Methotrexate is known to be effective in CTCL, with a response rate in the range of 58%. 5 Although methotrexate is widely available and the oral form is relatively inexpensive compared with other treatments for CTCL, 26 a topical formulation could provide an alternative to current therapeutic options, particularly in instances in which patients develop resistance or intolerance to currently available therapies. It has been shown that the median survival of patients with limited skin plaques is the same as that of age-matched controls. 27 Furthermore, a randomized trial demonstrated that aggressive therapy (combination chemotherapy and total skin electron beam therapy) did not offer a survival advantage over topical therapy in early-stage CTCL, 3 emphasizing the critical role of topical therapies in early-stage CTCL. Thus, topical treatments will continue to be first line of therapy for those patients with early-stage CTCL. A topical formulation of methotrexate should be cost-effective and could have several indications in dermatology. In conclusion, the primary objective of this phase 1/2 study was to assess the safety and tolerability of methotrexate-laurocapram, administered topically for 24 consecutive weeks in patients with early-stage CTCL. The results obtained are in agreement with previous findings in patients with psoriasis or MF, which indicate that methotrexate-laurocapram is safe and well tolerated and that there seems to be marginal systemic exposure to methotrexate using this formulation. Furthermore, despite the relatively low number of patients, positive results, some of which reached statistical significance, were obtained in the efficacy outcomes. Altogether, these findings indicate that methotrexate-laurocapram may represent a viable alternative treatment and route of administration for this patient population and warrant additional investigation aimed at further defining its efficacy profile. Accepted for publication September 17, This study was supported by grant FD-R from the Food and Drug Administration (Rockville, Md) Office of Orphan Products to Dr Leyland-Jones. We thank Marsha Stevens, RN, BSN, Jasmin Abd-el- Baki, MD, Atul Taneja, MD, and Frank Pietrantonio, PhD, for their help with the study. Corresponding author and reprints: Marie-France Demierre, MD, FRCPC, Skin Oncology Program, Department of Dermatology, Boston University School of Medicine, 720 Harrison Ave, Doctors Office Building, 801A, Boston, MA ( mariefrance.demierre@bmc.org). REFERENCES 1. Kim YH, Chow S, Varghese A, Hoppe RT. Clinical characteristics and long-term outcome of patients with generalized patch or plaque (T2) mycosis fungoides. Arch Dermatol. 1999;135: van Doorn R, Van Haselen CW, van Voorst Vader PC, et al. Mycosis fungoides: disease evolution and prognosis of 309 Dutch patients. Arch Dermatol. 2000; 136: Kaye FJ, Bunn PA Jr, Steinberg SM, et al. A randomized trial comparing combination electron-beam radiation and chemotherapy with topical therapy in the initial treatment of mycosis fungoides. N Engl J Med. 1989;321: Bunn PA Jr, Hoffman SJ, Norris D, Golitz LE, Aelig JL. Systemic therapy of cutaneous T-cell lymphomas (mycosis fungoides and the Sezary syndrome). Ann Intern Med. 1994;121: Zackheim HS, Kashani-Sabet M, Hwang ST. Low-dose methotrexate to treat erythrodermic cutaneous T-cell lymphoma: results in twenty-nine patients. J Am Acad Dermatol. 1996;34: Argyropoulos CL, Lamberg SI, Clendenning WE, et al. Preliminary evaluation of 15 chemotherapeutic agents applied topically in the treatment of mycosis fungoides. Cancer Treat Rep. 1979;63: Wiechers JW, de Zeeuw RA. Transdermal drug delivery: efficacy and potential applications of the penetration enhancer Azone. Drug Des Deliv. 1990;6: Wester RC, Melendres J, Sedik L, Maibach HI. Percutaneous absorption of Azone following single and multiple doses to human volunteers. J Pharm Sci. 1994; 83: Wiechers JW, Drenth BF, Adolfsen FA, Prins L, de Zeeuw RA. Disposition and metabolic profiling of the penetration enhancer Azone, I: in vivo studies: urinary profiles of hamster, rat, monkey, and man. Pharm Res. 1990;7: Chow DSL, Kaka I, Wang TI. Concentration-dependent enhancement of I- dodecyl (azacycloheptan-2-one) on the percutaneous penetration kinetics of Triamcinolone Acetonide. J Pharm Sci. 1984;73: Mollgaard B, Hoelgaard A. Dermal drug delivery: improvement by choice of vehicle or drug derivative. J Control Release. 1985;2: McCullough JL, Weinstein GD. Azone-enhanced topical delivery of methotrexate inhibits epidermal DNA synthesis in animal models. Skin Pharmacol. 1988; 1: Brain KR, Hadgraft J, Lewis D, Allan G. The influence of Azone on the percutaneous absorption of methotrexate. Int J Pharm. 1991;71:R9-R A Study to Assess the Degree of Systemic and Cutaneous Absorption of Topically Applied MTX/AZ in Patients With Psoriasis Vulgaris [data on file]. Richmond, Va: Whitby Research; Azone Drug Master File Weinstein GD, McCullough JL, Olsen E. Topical methotrexate therapy for psoriasis. Arch Dermatol. 1989;125: Sutton L, Swinehart JM, Cato A, Kaplan AS. A clinical study to determine the efficacy and safety of 1% methotrexate/azone (MAZ) gel applied topically once daily in patients with psoriasis vulgaris. Int J Dermatol. 2001;40: Pilot Study of Topically Applied MTX/AZ in Patients With Stage I Mycosis Fungoides [data on file]. Richmond, Va: Whitby Research; Azone Drug Master File Bunn PA Jr, Lambert S. Report of the committee on staging and classification of cutaneous T-cell lymphomas. Cancer Treat Rep. 1979;63: Zackheim HS, Kashami-Sabet M, Amin S. Topical corticosteroids for mycosis fungoides: experience in 79 patients. Arch Dermatol. 1998;134: Hoppe RT, Abel EA, Deneau DG, Price NM. Mycosis fungoides: management with topical nitrogen mustard. J Clin Oncol. 1987;5: Esteve E, Bagot M, Joly P, et al, for the French Study Group of Cutaneous Lymphomas. A prospective study of cutaneous intolerance to topical mechlorethamine therapy in patients with cutaneous T-cell lymphomas. Arch Dermatol. 1999; 135: Thomson KF, Sheehan-Dare RA, Wilkinson SM. Allergic contact dermatitis from topical carmustine. Contact Dermatitis. 2000;42: Zackheim HS. Cutaneous T cell lymphoma: update of treatment. Dermatology. 1999;199: Heald P, Mehlmauer M, Martin A, et al. The benefits of topical bexarotene (Targretin) in patients with refractory or persistent early stage CTCL [abstract]. JInvest Dermatol. 2000;114: Breneman D, Duvic M, Kuzel T, et al. Phase 1 and 2 trial of bexarotene gel for skin-directed treatment of patients with cutaneous T-cell lymphoma. Arch Dermatol. 2002;138: Fung MA, Murphy MJ, Hoss DM, Grant-Kels JM. Practical evaluation and management of cutaneous lymphoma. J Am Acad Dermatol. 2002;46: Zackheim HS, Amin S, Kashani-Sabet M, McMillan A. Prognosis in cutaneous T-cell lymphoma by skin stage: long-term survival in 489 patients. J Am Acad Dermatol. 1999;40:
Therapeutic Management of Early Cutaneous Mycosis Fungoides
Therapeutic Management of Early Cutaneous Mycosis Fungoides L Frank Glass, MD Cutaneous Lymphoma Programs H Lee Moffitt Cancer Center and Research Institute George Washington University Dermatology and
More informationSTUDY. Phase 1 and 2 Trial of Bexarotene Gel for Skin-Directed Treatment of Patients With Cutaneous T-Cell Lymphoma
STUDY Phase 1 and 2 Trial of Bexarotene Gel for Skin-Directed Treatment of Patients With Cutaneous T-Cell Lymphoma Debra Breneman, PhD; Madeleine Duvic, MD; Timothy Kuzel, MD; Richard Yocum, MD; Joseph
More informationAllogeneic Stem Cell Transplantation for Cutaneous T-cell Lymphoma: Updated results from a single center
Allogeneic Stem Cell Transplantation for Cutaneous T-cell Lymphoma: Updated results from a single center Madeleine Duvic, MD Professor and Deputy Chairman Blanche Bender Professor in Cancer Research Departments
More informationTitle A Phase II study of oral LBH589 in adult patients with refractory cutaneous T-Cell lymphoma
Sponsor Novartis Generic Drug Name Panobinostat Therapeutic Area of Trial Refractory cutaneous T-Cell lymphoma Approved Indication Investigational drug Protocol Number CLBH589B2201 Title A Phase II study
More information50 microgram/g Calcipotriol and 500 microgram/g betamethasone (as dipropionate).
DUPISOR Composition Gel 50 microgram/g Calcipotriol and 500 microgram/g betamethasone (as dipropionate). Action Calcipotriol is a non-steroidal antipsoriatic agent, derived from vitamin D. Calcipotriol
More informationTargretin. Targretin (bexarotene) Description
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.21.81 Subject: Targretin Page: 1 of 5 Last Review Date: June 22, 2017 Targretin Description Targretin
More informationClinical Management Of Psoriasis Using 0.25% Niosomal Methotrexate Gel: A Placebo Controlled Double Blind Study
ISPUB.COM The Internet Journal of Dermatology Volume 3 Number 1 Clinical Management Of Psoriasis Using 0.25% Niosomal Methotrexate Gel: A Placebo Controlled Double P Lakshmi, S Devi, S Bhaskaran, S Sacchidananda,
More informationTARGRETIN (bexarotene) oral capsule & external gel
TARGRETIN (bexarotene) oral capsule & external gel Coverage for services, procedures, medical devices and drugs are dependent upon benefit eligibility as outlined in the member's specific benefit plan.
More informationSTUDY. Trial Registration: clinicaltrials.gov Identifier: NCT (methyl-bis[2-chloroethyl]amine)
ONLINE FIRST STUDY Topical Chemotherapy in Cutaneous T-cell Lymphoma Positive Results of a Randomized, Controlled, Multicenter Trial Testing the Efficacy and Safety of a Novel Mechlorethamine, 0.02%, in
More informationSTUDY. Topical Corticosteroids for Mycosis Fungoides. Herschel S. Zackheim, MD; Mohammed Kashani-Sabet, MD; Smita Amin, MD
Topical Corticosteroids for Mycosis Fungoides Experience in 79 Patients STUDY Herschel S. Zackheim, MD; Mohammed Kashani-Sabet, MD; Smita Amin, MD Objective: To determine the effectiveness of topical corticosteroids
More informationDuring the last 20 years, the number of topical
THERAPEUTICS FOR THE CLINICIAN Cumulative Irritation Potential of Adapalene 0.1% Cream and Gel Compared With Tretinoin Microsphere 0.04% and 0.1% Jonathan S. Dosik, MD; Kenneth Homer, MS; Stéphanie Arsonnaud
More informationThis PDF is available for free download from a site hosted by Medknow Publications
Net Study Comparison of clinical efficacy of topical tazarotene.1% cream with topical clobetasol propionate.5% cream in chronic plaque psoriasis: A double-blind, randomized, right-left comparison study
More informationPhototherapy and Photochemotherapy Treatment (Ultraviolet A [PUVA] and B [UBV])
Origination: 09/27/07 Revised: 08/2/17 Annual Review: 11/2/17 Purpose: To provide Phototherapy and Photochemotherapy Treatment (PUVA and UBV) guidelines for the Medical Department staff to reference when
More informationThe study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More informationTo order reprints or e-prints of JDD articles please contact JDD
June 2017 534 VOLUME 16 ISSUE 6 Copyright 2017 ORIGINAL ARTICLE Journal of Drugs in Dermatology The Efficacy and Safety of Azelaic Acid 15% Foam in the Treatment of Truncal Acne Vulgaris Lauren K. Hoffman
More informationAn Efficacy Study of 3 Commercially Available Hydroquinone 4% Treatments for Melasma
An Efficacy Study of 3 Commercially Available Hydroquinone 4% Treatments for Melasma Pearl E. Grimes, MD Melasma is a common disorder of hyperpigmentation typically characterized by relatively symmetric
More informationKEY MESSAGES. Psoriasis patients are more prone to cardiovascular diseases, stroke, lymphoma and non-melanoma skin cancers, and increased mortality.
KEY MESSAGES Psoriasis is a genetically determined, systemic immune-mediated chronic inflammatory disease that affects primarily the skin and joints. Psoriasis Vulgaris is characterised by well-demarcated
More informationClinical Study Synopsis
Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace
More informationThis PDF is available for free download from a site hosted by Medknow Publications
Original Article Niosomal methotrexate gel in the treatment of localized psoriasis: Phase I and phase II studies P. K. Lakshmi, Gayathri S. Devi*, Shyamala Bhaskaran**, S. Sacchidanand*** Director-Drug
More informationA Pilot Study. Name of investigational product:
An Open Label, Multi Center Clinical Study to Evaluate the Efficacy and Safety of a New Topical Cosmeceutical in Relieving the Redness, Scaling and Flaking Associated with Severe Skin Conditions A Pilot
More informationNarrow band UVB (311 nm), psoralen UVB (311 nm) and PUVA therapy in the treatment of early-stage mycosis fungoides: a right left comparative study
Photodermatol Photoimmunol Photomed 2005; 21: 281 286 Blackwell Munksgaard Copyright r Blackwell Munksgaard 2005 Narrow band UVB (311 nm), psoralen UVB (311 nm) and therapy in the treatment of early-stage
More informationSignificant Impact of Cutaneous T-Cell Lymphoma on Patients Quality of Life. Results of a 2005 National Cutaneous Lymphoma Foundation Survey
2504 Significant Impact of Cutaneous T-Cell Lymphoma on Patients Quality of Life Results of a 2005 National Cutaneous Lymphoma Foundation Survey Marie-France Demierre, MD 1 Stephanie Gan, BA 1 Judy Jones
More informationPsoriasis is a lifelong condition, with onset
THERAPEUTICS FOR THE CLINICIAN Clobetasol Propionate Lotion in the Treatment of Moderate to Severe Plaque-Type Psoriasis Jacques Decroix, MD; Henrik Pres, MD; Nicolaï Tsankov, MD; Michel Poncet, PhD; Stéphanie
More informationCover Page. The handle holds various files of this Leiden University dissertation.
Cover Page The handle http://hdl.handle.net/1887/2010 holds various files of this Leiden University dissertation. Author: Benner, Marchina Frederika Title: Cutaneous CD30-positive lymphoproliferations
More informationOBSERVATION. Psoralen Plus Long-Wave UV-A (PUVA) and Bexarotene Therapy
OBSERVATION Psoralen Plus Long-Wave UV-A (PUVA) and Bexarotene Therapy An Effective and Synergistic Combined Adjunct to Therapy for Patients With Advanced Cutaneous T-Cell Lymphoma Karen S. McGinnis, MD;
More informationClinical Trial Outcomes
l Recent clinical evidence for topical mechlorethamine in mycosis fungoides Mycosis fungoides (MF) is a rare, potentially life-threatening cutaneous T-cell lymphoma characterized by cutaneous homing of
More informationClinical Study Synopsis for Public Disclosure
Clinical Study Synopsis for Public Disclosure These results are supplied for informational purposes only in the interest of scientific disclosure. The synopsis may include approved and non-approved uses,
More information2 Synopsis. Name of Sponsor/Company: Volume: Page: (For National Authority Use Only) Almirall Hermal GmbH. Name of Finished Product: LAS 41004
2 Synopsis Title of study: An Investigator-blind, Controlled Exploratory Study to Assess the Efficacy and Safety of Different Concentrations of Active Ingredients in the project Formulations of Compared
More informationCLINICAL STUDY REPORT SYNOPSIS
CLINICAL STUDY REPORT SYNOPSIS Document No.: EDMS-PSDB-5412862:2.0 Research & Development, L.L.C. Protocol No.: R115777-AML-301 Title of Study: A Randomized Study of Tipifarnib Versus Best Supportive Care
More informationISPUB.COM. Bexarotene in Tumor stage Mycosis Fungoides. R Talpur, M Duvic INITIAL PRESENTATION TREATMENT COURSE INTRODUCTION
ISPUB.COM The Internet Journal of Dermatology Volume 7 Number 3 Bexarotene in Tumor stage Mycosis Fungoides R Talpur, M Duvic Citation R Talpur, M Duvic. Bexarotene in Tumor stage Mycosis Fungoides. The
More informationThe study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More informationIndividual Study Table Referring to Part of the Dossier. Volume: Page:
2 Synopsis Title of study: An Investigator-blind, Controlled Study to Assess the Efficacy and Safety of Different Formulations of Compared to Placebo and to Active Control in a Psoriasis Plaque Test Investigators
More informationSynthetic hypericin (SGX301; VIMRxyn) for cutaneous T cell lymphoma, unspecified
NIHR Innovation Observatory Evidence Briefing: May 2017 Synthetic hypericin (SGX301; VIMRxyn) for cutaneous T cell lymphoma, unspecified NIHRIO (HSRIC) ID: 10761 NICE ID: 8375 LAY SUMMARY Cutaneous T cell
More informationDermatology nurses often serve as the primary
Gelling Your Dermatology Nursing Practice A Practical Guide for Managing the Treatment of Mycosis Fungoides Cutaneous T-Cell Lymphoma With Mechlorethamine Gel Sue A. McCann, Allister Benjamin Chase, Marianne
More informationCiclosporin Microemulsion for Severe Atopic Dermatitis: Experience on Adolescents and Adults in Hong Kong
ORIGINAL ARTICLES Ciclosporin Microemulsion for Severe Atopic Dermatitis: Experience on Adolescents and Adults in Hong Kong Drs. H. F. Ho, L.Y. Chong, K. M. Ho and W. K. Fung Social Hygiene Service (Dermatology),
More information1/19/2018. Early CTCL: treatment considerations
Treatment of early stage CTCL Joan Guitart, MD Chicago, IL USA Disclosures: Actelion (grants, consultant), Tetralogic/Medivir (grant, consultant), Solygenix (grant) Therakos (grant) Early CTCL: treatment
More informationclinical recommendations
19 (Supplement 2): ii72 ii76, 2008 doi:10.1093/annonc/mdn095 Primary cutaneous lymphoma: ESMO Clinical Recommendations for diagnosis, treatment and follow-up R. Dummer 1 & M. Dreyling 2 On behalf of the
More informationPFIZER INC. GENERIC DRUG NAME and/or COMPOUND NUMBER: 5% Spironolactone Cream/ PF
PFIZER INC. These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert. For publications based on this study, see associated bibliography.
More informationSTUDY. Trial Registration: clinicaltrials.gov Identifier: NCT (methyl-bis[2-chloroethyl]amine)
ONLINE FIRST STUDY Topical Chemotherapy in Cutaneous T-cell Lymphoma Positive Results of a Randomized, Controlled, Multicenter Trial Testing the Efficacy and Safety of a Novel Mechlorethamine, 0.02%, in
More informationClinical Study The Influence of the Coexpression of CD4 and CD8 in Cutaneous Lesions on Prognosis of Mycosis Fungoides: A Preliminary Study
Skin Cancer, Article ID 624143, 4 pages http://dx.doi.org/10.1155/2014/624143 Clinical Study The Influence of the Coexpression of CD4 and CD8 in Cutaneous Lesions on Prognosis of Mycosis Fungoides: A Preliminary
More informationNew Medicine Report. Pimecrolimus. RED- Hospital only Date of Last Revision 6 th March 2003
New Medicine Report Document Status Pimecrolimus Reviewed by Suffolk D&T RED- Hospital only Date of Last Revision 6 th March 2003 Approved Name Pimecrolimus Trade Name Elidel Manufacturer Novartis Legal
More informationTHE THERAPY OF THE REBEL SEVERE PSORIAZIS WITH BIOLOGICAL PREPARATS
Bulletin of the Transilvania University of Braşov Series VI: Medical Sciences Vol. 5 (54) No. 2-2012 THE THERAPY OF THE REBEL SEVERE PSORIAZIS WITH BIOLOGICAL PREPARATS Mădălina FRÎNCU 1 Abstract: Biological
More informationHUMAN PHOTOTOXICITY AND PHOTOALLERGENICITY TEST. April, 2006
HUMAN PHOTOTOXICITY AND PHOTOALLERGENICITY TEST April, 2006 Protocol Number: Title: Objective: Human Phototoxicity and Photoallergenicity Test The objective of the test is to assess the potential of a
More informationThe complex nature of the immunology of the skin
Menus for Managing Patients With Cutaneous T-Cell Lymphoma Brian Poligone, MD, PhD,* and Peter Heald, MD In the management of patients with cutaneous T-cell lymphoma (CTCL), there are numerous distinct
More informationClinical Study Synopsis for Public Disclosure
abcd Clinical Study Synopsis for Public Disclosure This clinical study synopsis is provided in line with s Policy on Transparency and Publication of Clinical Study Data. The synopsis - which is part of
More informationOncologic Dermatology and Surgery. Dra. Elena de las Heras
Oncologic Dermatology and Surgery Dra. Elena de las Heras Review and Updates: Clinical oncology: Lymphomas PROspective Cutaneous Lymphoma International Prognostic Index (PROCLIPI) study Launched in 2015
More informationIndividual Study Table Referring to Part of the Dossier. Volume:
2 Synopsis Title of study: An Investigator-blind, Controlled Study to Assess the Efficacy of Five Distinct Combinations of in Different Concentrations Compared to Placebo and to Two Active Controls in
More informationPrescribing Information
Prescribing Information Pr DERMOVATE Cream (clobetasol propionate cream, USP) Pr DERMOVATE Ointment (clobetasol propionate ointment, USP) Topical corticosteroid TaroPharma Preparation Date: A Division
More informationPotential for methotrexate exposure through contamination during parenteral use as an immunosuppressantimj_
Internal Medicine Journal 39 (2009) 379 383 ORIGINAL ARTICLE Potential for methotrexate exposure through contamination during parenteral use as an immunosuppressantimj_1716 379..383 L. S. Wong, 1,2 K.
More informationPhase 1 Study of the Safety and Efficacy of MRG-106, a Synthetic Inhibitor of microrna-155, in CTCL Patients
ASH Annual Meeting, December 11, 2017 Atlanta, Georgia, U.S.A. Phase 1 Study of the Safety and Efficacy of MRG-106, a Synthetic Inhibitor of microrna-155, in CTCL Patients Christiane Querfeld, Francine
More informationVALCHLOR 6 INFORMATION INSIDE
About VALCHLOR Application instructions included on page 6 INFORMATION INSIDE Understanding your condition Understanding VALCHLOR Applying and storing VALCHLOR Please see Important Safety Information throughout,
More information2 SYNOPSIS. Study code : MC 9308 FR.
MC9308 FR Study 19 December 2000 Page 15 of142 2 SYNOPSIS Study code : MC 9308 FR. Title: A comparative study of calcipotriol ointment in combination with narrow-band UVB (TL-01) phototherapy and placebo
More informationIs Apremilast (Otezla) Effective in Reducing Pruritus in Adults over 18 Years Old with Plaque Psoriasis?
Philadelphia College of Osteopathic Medicine DigitalCommons@PCOM PCOM Physician Assistant Studies Student Scholarship Student Dissertations, Theses and Papers 3-2017 Is Apremilast (Otezla) Effective in
More informationTopical Preparations
Topical Preparations One of the functions of the skin is to protect the internal body components against the external environment and thus to control the passage of chemicals into and out of the body.
More informationSubject ID: I N D # # U A * Consent Date: Day Month Year
IND Study # Eligibility Checklist Pg 1 of 15 Instructions: Check the appropriate box for each Inclusion and Exclusion Criterion below. Each criterion must be marked and all protocol criteria have to be
More informationChemical structure of calcipotriol
PRODUCT INFORMATION DAIVONEX CREAM AUST R 57354 Calcipotriol 50 microgram/g NAME OF THE MEDICINE: CALCIPOTRIOL DESCRIPTION Calcipotriol is a white or almost white crystalline substance. It is a vitamin
More informationPrimary Endpoint The primary endpoint is overall survival, measured as the time in weeks from randomization to date of death due to any cause.
CASE STUDY Randomized, Double-Blind, Phase III Trial of NES-822 plus AMO-1002 vs. AMO-1002 alone as first-line therapy in patients with advanced pancreatic cancer This is a multicenter, randomized Phase
More informationClinical Trial Report Synopsis
Clinical Trial Report Synopsis A phase 2a, proof of concept trial, testing twice daily application of LEO 124249 ointment 30 mg/g in the treatment of mild to moderate inverse psoriasis Design of trial:
More informationISPUB.COM. M Duvic, E Olsen PURPOSE OF REVISION
ISPUB.COM The Internet Journal of Dermatology Volume 7 Number 3 International Society of Cutaneous Lymphoma (ISCL) and the European Organization of Research and Treatment of Cancer (EORTC) revisions to
More informationPrescribing Information. Taro-Clobetasol. Taro-Clobetasol
Prescribing Information Pr Taro-Clobetasol Clobetasol Propionate Cream USP, 0.05% w/w Pr Taro-Clobetasol Clobetasol Propionate Ointment USP, 0.05% w/w Therapeutic Classification Topical corticosteroid
More informationAna Luisa Stuckett, PhD, MS
Ana Luisa Stuckett, PhD, MS alstuckett@mdanderson.org Clinical Studies Coordinator Investigational Cancer Therapeutics (Phase I) MD Anderson Cancer Center Houston, Texas Education Ph.D., Microbiology,
More informationProtocol Abstract and Schema
Protocol Abstract and Schema A Phase 1 and Phase II Study of AZD6244 for Recurrent or Refractory Pediatric Low Grade Glioma Description and Rationale: Low grade gliomas are among the most common primary
More informationSupportive Care in the Management of T-cell Lymphomas
Supportive Care in the Management of T-cell Lymphomas Erin Kopp, ACNP-BC City of Hope Comprehensive Cancer Center NCCN.org For Clinicians NCCN.org/patients For Patients Objectives Discuss the role of supportive
More informationPatients who achieved the primary criterion for response i.e.: complete clearance or a reduction
MC 9101 F Study Page3 ABSTRACT Background: Cyclosporin A has been shown to be an effective systemic treatment in severe psoriasis but with the disadvantage of dose-dependent toxic effects particularly
More informationREGISTRY OF SEVERE CUTANEOUS ADVERSE REACTIONS TO DRUGS AND COLLECTION OF BIOLOGICAL SAMPLES. R e g i S C A R PATIENT'S DATA. Age country of birth
REGISTRY OF SEVERE CUTANEOUS ADVERSE REACTIONS TO DRUGS AND COLLECTION OF BIOLOGICAL SAMPLES R e g i S C A R PATIENT'S DATA Initials of the patient date of birth Age country of birth Gender male female
More informationAN2728 Clinical Data in Atopic Dermatitis
AN2728 Clinical Data in Atopic Dermatitis Karl Beutner, MD, PhD 1 Overview of AN2728 in Atopic Dermatitis Target Product Profile Safe and effective topical therapy for atopic dermatitis Efficacy in the
More informationThe Treatment Toolbox for Severe Pediatric Psoriasis
The Treatment Toolbox for Severe Pediatric Psoriasis Dr. Kim A. Papp, MD, PhD, FRCPC, FAAD K Papp Clinical Research and Probity Medical Research Objectives: Treating severe pediatric psoriasis 1. Challenges
More informationCH 2 H 3 C CH 3 CH 3 COOH. Bexarotene is an off-white to white powder with a molecular weight of and a molecular formula of C 24 O 2
DESCRIPTION Targretin (bexarotene) gel 1% contains bexarotene and is intended for topical application only. Bexarotene is a member of a subclass of retinoids that selectively activate retinoid X receptors
More informationEvaluation of Imuspora Tablets and Ointment (Multi-Ingredient Herbal Formulation) In the Management of Psoriasis: An Open Trial
Evaluation of Imuspora Tablets and Ointment (Multi-Ingredient Herbal Formulation) In the Management of Psoriasis: An Open Trial Background: D G Saple*, S Medhekar** & M Patil*** *Professor & Head, Department
More informationA case of rosacea fulminans in a pregnant woman
Hong Kong J. Dermatol. Venereol. (2018) 26, 122-126 Views and Practice A case of rosacea fulminans in a pregnant woman JE Seol, SH Park, JU Kim, GJ Cho, SH Moon, H Kim Introduction Rosacea fulminans (RF)
More informationClinical Study Synopsis
Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace
More informationKeywords: Psoriasis vulgaris Zinc pyrithione Betamethasone dipropionate
CLINICAL EFFICACY AND SAFETY OF A COMBINED FORMULATION OF ZINC PYRITHIONE 0.25% AND BETAMETHASONE DIPROPIONATE MICRONIZED 0.05% IN THE TREATMENT OF MILD TO MODERATE PLAQUE PSORIASIS. Abstract Background
More informationFeasibility Trial of Optune for Children with Recurrent or Progressive Supratentorial High-Grade Glioma and Ependymoma
Feasibility Trial of Optune for Children with Recurrent or Progressive Supratentorial High-Grade Glioma and Ependymoma ABSTRACT Recurrent or progressive pediatric CNS tumors generally have a poor prognosis
More informationPhototherapy for Psoriasis. Henry W. Lim, MD Chairman and C.S. Livingood Chair Department of Dermatology Henry Ford Hospital, Detroit, MI, USA
Phototherapy for Psoriasis Henry W. Lim, MD Chairman and C.S. Livingood Chair Department of Dermatology Henry Ford Hospital, Detroit, MI, USA Disclosure Investigator: Clinuvel Estée Lauder Ferndale Incyte
More informationOUR EXPERIENCES WITH ERLOTINIB IN SECOND AND THIRD LINE TREATMENT PATIENTS WITH ADVANCED STAGE IIIB/ IV NON-SMALL CELL LUNG CANCER
& OUR EXPERIENCES WITH ERLOTINIB IN SECOND AND THIRD LINE TREATMENT PATIENTS WITH ADVANCED STAGE IIIB/ IV NON-SMALL CELL LUNG CANCER Interim Data Report of TRUST study on patients from Bosnia and Herzegovina
More informationAbstract and Schema. Phase 1 and Pharmacokinetic Study of AZD6244 for Recurrent or Refractory Pediatric Low Grade Glioma
Abstract and Schema Phase 1 and Pharmacokinetic Study of AZD6244 for Recurrent or Refractory Pediatric Low Grade Glioma Description and Rationale: Low grade gliomas are among the most common primary CNS
More informationTOPCORT Cream/Ointment (Mometasone furoate 0.1%)
Published on: 10 Jul 2014 TOPCORT Cream/Ointment (Mometasone furoate 0.1%) Composition TOPCORT Cream Mometasone Furoate, IP... 0.1% w/w In a cream base... q.s. TOPCORT Ointment Mometasone Furoate, IP...
More informationCUTANEOUS T-CELL LYMPHOMA PROFORMA
STATE OF KUWAIT MINISTRY OF HEALTH AS AD ALHAMAD DERMATOLOGY CENTER ALSABAH HOSPITAL دولة الكویت وزارة الصحة مرآز أسعد الحمد للا مراض الجلدیة مستشفى الصباح بسم االله الرحمن الرحيم CUTANEOUS TCELL LYMPHOMA
More informationDRAFT GUIDANCE DOCUMENT Comparative Bioavailability Standards: Formulations Used for Systemic Effects
1 2 3 DRAFT GUIDANCE DOCUMENT Comparative Bioavailability Standards: Formulations Used for Systemic Effects 4 This guidance document is being distributed for comment purposes only. 5 6 Published by authority
More informationSponsor Novartis. Generic Drug Name Vildagliptin/Metformin. Therapeutic Area of Trial Type 2 diabetes. Approved Indication Type 2 diabetes
Clinical Trial Results Database Page 1 Sponsor Novartis Generic Drug Name Vildagliptin/Metformin Therapeutic Area of Trial Type 2 diabetes Approved Indication Type 2 diabetes Study Number CLMF237A2309
More informationAbstract and Schema. Phase 1 and Pharmacokinetic Study of AZD6244 for Recurrent or Refractory Pediatric Low Grade Glioma
Abstract and Schema Phase 1 and Pharmacokinetic Study of AZD6244 for Recurrent or Refractory Pediatric Low Grade Glioma Description and Rationale: Low grade gliomas are among the most common primary CNS
More informationAnalysis of causation of Stevens Johnson Syndrome in a patient of rheumatoid arthritis with increased dose of methotrexate
Original Research Article Analysis of causation of Stevens Johnson Syndrome in a patient of rheumatoid arthritis with increased dose of methotrexate Manab Nandy 1, Sangeeta De 2*, Mustafa Asad 2, Nirmal
More informationElements for a Public Summary
VI.2 Elements for a Public Summary VI.2.1 Overview of disease epidemiology Chronic lymphocytic leukaemia 1 Chronic lymphocytic leukemia (CLL) is a condition characterized by a progressive accumulation
More information2.0 Synopsis. Adalimumab R&D/04/118. (For National Authority Use Only) Referring to Part of Dossier: Volume:
2.0 Synopsis Abbott Laboratories Name of Study Drug: Adalimumab Name of Active Ingredient: Adalimumab Title of Study: Individual Study Table Referring to Part of Dossier: Volume: Page: (For National Authority
More information11 August 2000 Page 17 of 181. Subtitle A prospective, multicentre, randomised, double-blind, vehicle-controlled, parallel groupr comparative study.
Study MCO 9604 DE 11 August 2000 Page 17 of 181 2 SYNOPSIS Study Code MCO 9604 DE. Title Addition of Daivonex (calcipotriol) ointment (50 J.Lg!g) to fumaric acid therapy in patients with severe psoriasis
More informationLUMACIP PLUS Cream (Fluocinolone acetonide 0.01% + Hydroquinone 4% + Tretinoin 0.05%)
Published on: 10 Jul 2014 LUMACIP PLUS Cream (Fluocinolone acetonide 0.01% + Hydroquinone 4% + Tretinoin 0.05%) Composition LUMACIP PLUS Cream Each gram contains: Fluocinolone acetonide IP.. 0.01% w/w
More informationPatients and Methods
Phase II Study of Recombinant Human Interferon Gamma for Treatment of Cutaneous T-Cell Lymphoma Edward H. Kaplan, * Steven T. Rosen, David B. Norris, Henry H. Roenigk, Jr., Samuel R Saks, Paul A. Bunn,
More informationVI.2 Elements for a public summary
VI.2 Elements for a public summary VI.2.1 Overview of disease epidemiology Leukaemia is a cancer that starts in the blood-forming cells of the bone marrow. Chronic lymphocytic leukaemia (CLL) is a type
More informationPhase 1 Trial Evaluating MRG-106, a Synthetic Inhibitor of microrna- 155, in Patients with CTCL
EORTC CLTF 2017 meeting on Cutaneous Lymphomas: Insights & Therapeutic Progress Phase 1 Trial Evaluating MRG-106, a Synthetic Inhibitor of microrna- 155, in Patients with CTCL Christiane Querfeld, Francine
More informationRecalcitrant Warty Erythroderma With Severe Pruritus. Gil Yosipovitch Professor & Chair Department of Dermatology & Itch Center Temple University
Recalcitrant Warty Erythroderma With Severe Pruritus Gil Yosipovitch Professor & Chair Department of Dermatology & Itch Center Temple University DISCLOSURE OF RELEVANT RELATIONSHIPS WITH INDUSTRY Gil Yosipovitch,
More informationNail Psoriasis Blinded STUDY SYNOPSIS
Nail Psoriasis Blinded STUDY SYNOPSIS Study Title Development Phase Phase 3 Study Medication Primary Objective Secondary Objectives A randomized, double-blind, vehicle-controlled, parallel-group trial
More informationAlemtuzumab in Cutaneous Lymphoma
Alemtuzumab in Cutaneous Lymphoma Indication: Treatment of patients with Cutaneous Lymphoma (Unlicensed use) 1. Disease control prior to Reduced Intensity Conditioning Stem Cell Transplant 2. Palliative
More informationMichi Shinohara MD Associate Professor University of Washington/Seattle Cancer Care Alliance Dermatology, Dermatopathology
Michi Shinohara MD Associate Professor University of Washington/Seattle Cancer Care Alliance Dermatology, Dermatopathology Agenda Overview of cutaneous T and B- cell lymphomas Diagnosis, Staging, Prognosis
More informationSynopsis Style Clinical Study Report SAR ACT sarilumab Version number : 1 (electronic 1.0)
SYNOPSIS Title of the study: A randomized, double-blind, parallel-group, placebo- and active calibrator-controlled study assessing the clinical benefit of SAR153191 subcutaneous (SC) on top of methotrexate
More informationSkin SSG (Anglia East & Anglia West)
Guidelines for the Management of Primary Cutaneous T-Cell Lymphomas Skin SSG (Anglia East & Anglia West) Author: S J Whittaker, J R Marsden, M Spittle and R Russell Jones Approved by: Anglia Cancer Network
More informationCorporate Medical Policy
Corporate Medical Policy Ultraviolet Light Therapy in the Home Setting(UVB) File Name: Origination: Last CAP Review: Next CAP Review: Last Review: ultraviolet_light_therapy_in_the_home 3/1996 11/2017 11/2018
More informationManagement of Mycosis Fungoides: Part 2. Treatment
Review Article [1] October 01, 2003 By Benjamin D. Smith, MD [2] and Lynn D. Wilson, MD, MPH [3] Mycosis fungoides is a low-grade lymphoproliferative disorder of skin-homing CD4+ lymphocytes that may produce
More information(For National Authority Use Only) Name of Study Drug: to Part of Dossier:
2.0 Synopsis Abbott Laboratories Individual Study Table Referring to Part of Dossier: (For National Authority Use Only) Name of Study Drug: Volume: ABT-335 Name of Active Ingredient: Page: ABT-335, A-7770335.115
More informationFluorescence Diagnosis For Follow- Up Of Mycosis Fungoides Therapy
Fluorescence Diagnosis For Follow- Up Of Mycosis Fungoides Therapy Bosseila M*, Al-Helf F, El-Sayed A, Mahgoub D*, Metwally D*, El-Shaer M Dermatology Dept*, Cairo Univ., Dermatology Dept, National Research
More informationBC Cancer Protocol Summary for Treatment of Chronic Lymphocytic Leukemia or Prolymphocytic Leukemia with Fludarabine and rituximab
BC Cancer Protocol Summary for Treatment of Chronic Lymphocytic Leukemia or Prolymphocytic Leukemia with Fludarabine and rituximab Protocol Code Tumour Group Contact Physicians LYCLLFLUDR Lymphoma Dr.
More information