Record #8 of 12 ID: CN AU: Gilbert SC

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1 Record #1 of 12 ID: CN AU: Hargate G TI: A randomised double-blind study comparing the effect of 1072-nm light against placebo for the treatment of herpes labialis. SO: Clinical and experimental dermatology YR: 2006 VL: 31 NO: 5 PG: PM: PUBMED XR: EMBASE AD: Newlands Medical Centre, Borough Road, Middlesbrough, UK. g.hargate@ntlworld.com US: /frame.html AB: BACKGROUND: Previous research demonstrated that 1072-nm narrowband laser light is effective in the treatment of cold sores.aim: To evaluate the efficacy of an over-the-counter cold-sore treatment device (Virulite CS) incorporating 1072-nm light-emitting diodes.methods: A randomised, prospective, double-blind, self-reported study was performed to compare the efficacy of at least six 3-min treatments of 1072-nm narrowband light against placebo, in the treatment of herpes labialis.results: The 1072-nm light-emitting diode device reduced coldsore healing time to 6.3 days compared with 9.4 days for placebo (P=0.048). The time the cold sore took to form a crust was also reduced from 2.00 days for those treated with 1072-nm light, compared with 2.88 days for placebo (P=0.059)CONCLUSIONS: The significant difference between the mean healing times in the two groups demonstrates that the Virulite CS device is an effective means of treating herpes labialis. Record #2 of 12 ID: CN AU: Hull CM AU: Harmenberg J AU: Arlander E AU: Aoki F AU: Bring J AU: Darpˆ B AU: Levin MJ AU: Tyring S AU: Spruance SL AU: ME-609 Study Group TI: Early treatment of cold sores with topical ME-609 decreases the frequency of ulcerative lesions: a randomized, double-blind, placebo-controlled, patientinitiated clinical trial. SO: Journal of the American Academy of Dermatology YR: 2011 VL: 64 NO: 4 PG: 696.e1-11 PM: PUBMED PT: Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S.

2 AD: Department of Dermatology, School of Medicine, University of Utah, Salt Lake City, Utah , USA. US: /frame.html AB: BACKGROUND: Prior pilot studies support the use of antiviral medications with topical corticosteroids for herpes simplex labialis (HSL). ME-609 (Xerese, Xerclear) is a combination of 5% acyclovir and 1% hydrocortisone developed for the topical treatment of HSL.OBJECTIVES: The primary study end point was the prevention of ulcerative HSL lesions.methods: In all, 2437 patients with a history of HSL were randomized to self-initiate treatment with ME-609, 5% acyclovir in ME-609 vehicle, or ME-609 vehicle (placebo) at the earliest sign of a cold sore recurrence. Cream was applied 5 times/d for 5 days. A total of 1443 patients experienced a recurrence and initiated treatment with ME-609 (n = 601), acyclovir (n = 610), or placebo (n = 232).RESULTS: Of patients receiving ME-609, 42% did not develop an ulcerative lesion compared with 35% of patients receiving acyclovir in ME-609 vehicle (P =.014) and 26% of patients receiving placebo (P <.0001). In patients with ulcerative lesions, healing times were reduced in the ME-609 and acyclovir groups compared with placebo (P <.01 for both). The cumulative lesion area for all lesions was reduced 50% in patients receiving ME-609 compared with the placebo group (P <.0001). There were no differences among groups in the number of patients with positive herpes simplex virus cultures. The side-effect profile was similar among treatments.limitations: The study did not contain a group treated with a topical corticosteroid alone.conclusions: ME-609 prevented progression of cold sores to ulcerative lesions and significantly reduced the cumulative lesion area compared with acyclovir and placebo. ME-609 treatment offers additional therapeutic benefit compared with therapy with topical acyclovir alone. Record #3 of 12 ID: CN AU: de Carvalho RR AU: de Paula Eduardo F AU: Ramalho KM AU: Antunes JL AU: Bezinelli LM AU: de Magalh es MH AU: Pegoretti T AU: de Freitas PM AU: de Paula Eduardo C TI: Effect of laser phototherapy on recurring herpes labialis prevention: an in vivo study. SO: Lasers in medical science YR: 2010 VL: 25 NO: 3 PG: PM: PUBMED AD: Special Laboratory of Lasers in Dentistry, Department of Restorative Dentistry, School of Dentistry, University of S o Paulo, S o Paulo , SP, Brazil. US: /frame.html AB: Alternative treatment for recurrent labial infection by herpes simplex virus (HSV) have been considered. The aim of this study was to evaluate the effectiveness of laser phototherapy in prevention and reduction of severity of

3 labial manifestations of herpes labialis virus. Seventy-one patients, divided into experimental (n = 41) and control (n = 30) groups were followed up for 16 months. Patients in the control group were treated topically with aciclovir and patients in the experimental group were subjected to laser phototherapy (one session per week, 10 weeks): 780 nm, 60 mw, 3.0 J/cm(2) or 4.5 J/cm(2) on healthy (no HSV-1 infection) and affected (with HSV-1 infection) tissues. Patients in the experimental group presented a significant decrease in dimension of herpes labialis lesions (P = 0.013) and inflammatory edema (P = 0.031). The reduction in pain level (P = 0.051) and monthly recurrences (P = 0.076) did not reach statistical significance. This study represents an in vivo indication that this treatment should be further considered as an effective alternative to therapeutic regimens for herpes labialis lesions. Record #4 of 12 ID: CN AU: Gilbert SC TI: Oral shedding of herpes simplex virus type 1 in immunocompetent persons. SO: Journal of oral pathology & medicine : official publication of the International Association of Oral Pathologists and the American Academy of Oral Pathology YR: 2006 VL: 35 NO: 9 PG: PM: PUBMED AD: Department of Medicine, University of Washington, Seattle WA 98195, USA. scgilbert@hinet.org US: /frame.html AB: BACKGROUND: Reactivation of herpes simplex virus-1 (HSV-1) can result in recurrent herpes labialis lesions (RHL) and in oral shedding of virus. This study utilized polymerase chain reaction (PCR) to document the frequency and quantity of such shedding.methods: Thirty adults with greater than three RHL episodes per year were followed through one recurrence. They collected swabs for PCR every 12 h starting at prodrome and for 10 days thereafter. Shedding was analyzed with regard to frequency, timing and quantity.results: HSV-1 was detectable in 87% of participants for a mean of 4 days. Shedding occurred most frequently during the vesicle/ulcer stage (91% of subjects), but was common in both clinical and subclinical stages (50% vs. 23%, average log DNA copy number/ml(2) 2.6 vs. 1.4).CONCLUSION: The majority of RHL patients shed viral DNA. Shedding occurred before and after the appearance of clinical lesions. Such findings may be useful in designing methods to reduce viral shedding and prevent transmission. Record #5 of 12 ID: CN AU: Karlsmark T AU: Goodman JJ AU: Drouault Y AU: Lufrano L AU: Pledger GW AU: Cold Sore Study Group TI: Randomized clinical study comparing Compeed cold sore patch to acyclovir cream 5% in the treatment of herpes simplex labialis.

4 SO: Journal of the European Academy of Dermatology and Venereology : JEADV YR: 2008 VL: 22 NO: 10 PG: PM: PUBMED XR: EMBASE PT: Journal Article; Randomized Controlled Trial AD: Bispebjerg Hospital, Copenhagen NV, Denmark. US: /frame.html AB: BACKGROUND: Hydrocolloid technology has been proven effective in treating dermal wounds. A previous study showed that a newly developed thin hydrocolloid patch [Compeed cold sore patch (CSP)] provided multiple wound-healing benefits across all stages of a herpes simplex labialis (HSL) outbreak.methods: An assessment of CSP efficacy and safety was conducted in an international, multicentre, assessor-blinded study, which enrolled 728 subjects with a history of recurrent HSL. Of these, 351 experienced an HSL outbreak and were randomized to use CSP (n = 179) or acyclovir cream 5% (n = 172) at the onset of symptoms until the lesion healed, for a maximum of 10 days. The primary end point was the subject's global assessment of therapy (SGAT; 0-10 scale; 0 = no response, 10 = excellent response). Multiple secondary end points included clinicianassessed healing time and subject assessment of lesion protection, noticeability and social embarrassment.results: CSP and acyclovir were highly effective (mean SGAT = 7.89 and 8.00, respectively), with no significant difference observed (P = 0.65). The difference in healing times between products was not significant (median, 7.57 days with CSP vs days with acyclovir, P = 0.37). Both treatments were well tolerated.conclusion: CSP using hydrocolloid technology provides an efficacious and safe alternative to topical antivirals in treating HSL as a wound while affording additional immediate benefits of wound protection, discretion and relief of social embarrassment. Record #6 of 12 ID: CN AU: Zschocke I AU: Reich C AU: Zielke A AU: Reitmeier N AU: Reich K TI: Silica gel is as effective as acyclovir cream in patients with recurrent herpes labialis: results of a randomized, open-label trial. SO: The Journal of dermatological treatment YR: 2008 VL: 19 NO: 3 PG: PM: PUBMED PT: Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. AD: SCIderm Institute for Clinical Research, Hamburg, Germany. US: /frame.html AB: OBJECTIVE: To compare silica gel with acyclovir cream in the treatment of recurrent herpes labialis.methods: In this randomized, open-label, comparatorcontrolled trial, 74 patients with recurrent herpes labialis applied silica gel or acyclovir cream respectively over a period of 10 days. The treatment started within 24 hours of the first symptoms of a new recurrence. Patients rated five

5 symptoms (tautness, tingling, itching, burning sensation, pain), lesion stage, efficacy, tolerability, and duration until the onset of improvement. Their willingness-to-pay was assessed. Physicians rated the severity of the herpes recurrence and efficacy.results: There was no significant difference between silica gel and acyclovir cream in the overall patients' assessment. There is evidence that silica gel relieved all investigated symptoms earlier than acyclovir cream. The efficacy and tolerability of both medications were rated as good to very good.conclusions: Silica gel was as effective in the treatment of recurrent herpes labialis as acyclovir and equally well tolerated and tended to take effect more quickly. Therefore, silica gel could prove a useful alternative to topical acyclovir. Record #7 of 12 ID: CN AU: Spruance SL AU: Bodsworth N AU: Resnick H AU: Conant M AU: Oeuvray C AU: Gao J AU: Hamed K TI: Single-dose, patient-initiated famciclovir: a randomized, double-blind, placebo-controlled trial for episodic treatment of herpes labialis. SO: Journal of the American Academy of Dermatology YR: 2006 VL: 55 NO: 1 PG: PM: PUBMED XR: EMBASE PT: Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. AD: Division of Infectious Diseases, University of Utah School of Medicine, Salt Lake City, UT , USA. US: /frame.html AB: BACKGROUND: The brief period of viral replication in recurrent herpes labialis lesions suggests shorter therapeutic regimens are a logical episodic treatment strategy.objective: We sought to assess the efficacy and safety of single-dose and single-day famciclovir treatments.methods: In all, 701 randomly assigned patients self-initiated therapy with famciclovir (1500 mg once [single dose] or 750 mg twice a day for 1 day [single day]) or placebo within 1 hour of onset of the prodromal symptoms of an episode of herpes labialis. Lesion healing was monitored by diaries and frequent clinic visits.results: Median healing times of primary (first to appear) vesicular lesions in the famciclovir single-dose, famciclovir single-day, and placebo groups were 4.4, 4.0, and 6.2 days, respectively. There was no significant difference between the famciclovir regimens. Adverse events in the famciclovir groups were similar to placebo.limitations: The active arms of this trial were not directly compared to other antiviral regimens.conclusion: Single-dose famciclovir reduced time to healing of herpes labialis lesions by approximately 2 days compared with placebo. Record #8 of 12 ID: CN AU: Gilbert SC

6 TI: Suppressive therapy versus episodic therapy with oral valacyclovir for recurrent herpes labialis: efficacy and tolerability in an open-label, crossover study. SO: Journal of drugs in dermatology : JDD YR: 2007 VL: 6 NO: 4 PG: PM: PUBMED PT: Randomized Controlled Trial; Research Support, Non-U.S. AD: Department of Medicine, Division of Dermatology, University of Washington, Dermatology and Laser Center, Bellingham, WA 98225, USA. scgilbert@hinet.org US: /frame.html AB: Oral valacyclovir's efficacy and tolerability as suppressive therapy versus episodic therapy were compared for recurrent herpes labialis (RHL). Subjects with a history of at least 3 RHL episodes in the past year were randomized to receive 6 months of oral valacyclovir episodic therapy at the first sign of prodrome (two 2-g doses separated by 12 hours) and 6 months of oral valacyclovir suppressive therapy (1 g once daily) for 6 months in open-label, crossover fashion. The mean +/- SE number of recurrences per 120 days of follow-up (primary endpoint) was lower with suppressive therapy (0.30 +/- 0.41) than episodic therapy (0.71 +/- 0.79) (P <.005). The probability of remaining recurrence free over 6 months was significantly higher with suppressive therapy than episodic therapy. The median time to first recurrence was 81 days with episodic therapy and was not calculable (> 180 days) for suppressive therapy (P = 0.021). Data for secondary efficacy endpoints (pain severity score, mean duration of recurrences, maximal total lesion area) showed approximately a 30% to 50% reduction in mean values with suppressive therapy compared with episodic therapy, but results were statistically significantly different between the regimens for pain severity only. The percentage of subjects with at least one adverse event over 6 months of treatment that was considered to be drug related was 3% with suppressive therapy and 6% with episodic therapy. Suppressive therapy with oral valacyclovir was more effective than episodic therapy with oral valacyclovir in reducing the frequency of recurrences of herpes labialis and prolonging the time to first recurrence and was also similarly welltolerated. Record #9 of 12 ID: CN AU: Hull CM,Brunton S TI: The role of topical 5% acyclovir and 1% hydrocortisone cream (Xerese) in the treatment of recurrent herpes simplex labialis SO: Postgraduate Medicine YR: 2010 VL: 122 NO: 5 US: /frame.htm Record #10 of 12 ID: CN AU: Busch R AU: Graubaum HJ AU: Gruenwald J AU: Faergemann J TI: Therapeutic effect of 1,5-pentanediol for herpes simplex labialis: a randomized, double-blind, placebo-controlled clinical trial.

7 SO: Advances in therapy YR: 2009 VL: 26 NO: 7 PG: PM: PUBMED AD: Analyze & Realize AG, DE Berlin, Germany. US: /frame.html AB: INTRODUCTION: Most episodes of recurrent herpes labialis are self-limited and mild, but can be troublesome when they occur frequently with painful and unsightly lesions. Therefore, there has been much interest in developing agents that can suppress outbreaks in addition to being therapeutically effective. The objective of the present study was to examine the prophylactic and therapeutic efficacy of 1,5-pentanediol (PD) gel in patients with recurrent episodes of herpes labialis.methods: In this placebo-controlled, randomized, double-blind clinical trial, a total of 105 patients with frequent episodes of recurrent herpes were randomized to either PD or placebo. During the 26-week prophylactic phase of the study, the patients applied PD gel or placebo gel twice daily to both lips. Upon recurrence of an episode, a 5-day therapy phase started during which the gel was to be applied eight times daily. After the therapy phase, the patient resumed prophylactic treatment twice daily until the next herpes episode. The main outcome measures were number of herpes episodes during the prophylactic phase of 26 weeks, and successful therapy of occurring herpes episodes with a 5-day treatment.results: There was no significant difference in recurrence rate between the two groups (P>0.05). During recurrence there was a statistically significant improvement regarding the therapeutic effect of the symptoms "blistering," "swelling," and "pain" in the PD group. The global evaluation of efficacy by the investigators and patients showed a statistically significant superiority for PD as opposed to placebo (P<0.001).CONCLUSION: Under the conditions used in the present study, PD did not show any prophylactic effect against recurrence of herpes episodes. A significantly better therapeutic effect of PD over placebo could be demonstrated on the symptoms "blistering," "swelling," and "pain." PD was very safe as no side effects were observed during the course of the study. Record #11 of 12 ID: CN AU: Morrel EM AU: Spruance SL AU: Goldberg DI AU: Iontophoretic Acyclovir Cold Sore Study Group TI: Topical iontophoretic administration of acyclovir for the episodic treatment of herpes labialis: a randomized, double-blind, placebo-controlled, clinic-initiated trial. SO: Clinical infectious diseases : an official publication of the Infectious Diseases Society of America YR: 2006 VL: 43 NO: 4 PG: PM: PUBMED XR: EMBASE PT: Journal Article; Multicenter Study; Randomized Controlled Trial AD: Transport Pharmaceuticals, Framingham, Massachusetts 01701, USA.

8 US: /frame.html AB: BACKGROUND: Multiple studies of the use of acyclovir for the treatment of herpes labialis have suggested that the nominal efficacy of the topical formulation is the result of inadequate penetration of the drug into the target site of infection, the basal epidermis.methods: We developed a low-voltage, wireless, hand-held, computer-controlled, iontophoretic applicator to enhance the skin penetration of topical acyclovir in the treatment of herpes labialis. We performed a multicenter, placebo-controlled, clinic-initiated, pilot trial of a single, topical, iontophoretic application of 5% acyclovir cream for the episodic treatment of herpes labialis among 200 patients with an incipient cold sore outbreak at the erythema or papular/edema lesion stage.results: The median classic lesion healing time (aborted lesions were assigned a value of 0 h) was 1.5 days shorter for the active treatment group than for the vehicle group (113 h vs. 148 h; P =.02). In the subgroup of patients who presented with lesions in the erythema stage, the median classic lesion healing time was 3 days shorter for the acyclovir group, compared with the control group (49 h vs. 120 h; P <.03), and the acyclovir group tended to have more aborted lesions than did the control group (46% vs. 24%; P =.10).CONCLUSIONS: Single-dose topical iontophoresis of acyclovir appears to be a convenient and effective treatment for cold sores and merits further clinical investigation. Record #12 of 12 ID: CN AU: Hull C AU: McKeough M AU: Sebastian K AU: Kriesel J AU: Spruance S TI: Valacyclovir and topical clobetasol gel for the episodic treatment of herpes labialis: a patient-initiated, double-blind, placebo-controlled pilot trial. SO: Journal of the European Academy of Dermatology and Venereology : JEADV YR: 2009 VL: 23 NO: 3 PG: PM: PUBMED AD: Department of Dermatology, University of Utah, Salt Lake City, UT, USA. christopher.hull@hsc.utah.edu US: /frame.html AB: BACKGROUND: Treatment of herpes simplex labialis (HSL) has been associated with modest benefits. This difficulty results from the rapid resolution of the disease accomplished by the immune system, which narrows the window of therapeutic opportunity. The immune response is also responsible for important clinical manifestations, including oedema and pain. The dual role of immune responses (protection, pathology) is well recognized in other infectious diseases. The addition of corticosteroids to antimicrobial agents has been associated with improvement in some of these diseases.objective: We evaluated the combination of oral valacyclovir plus topical clobetasol compared to placebo for recurrent HSL.METHODS: Eighty-one subjects were screened, randomized, and dispensed medication (valacyclovir 2 g orally twice daily phiomicronrho 1 day and clobetasol gel 0.05% twice daily for 3 days). Forty-two patients developed a recurrence and initiated treatment.results: There were

9 more aborted lesions in the valacyclovir-clobetasol arm compared to placeboplacebo (50% vs.15.8%, P = 0.04). Combination therapy reduced the mean maximum lesion size (9.7 vs. 54 mm(2), P = 0.002) and the mean healing time of classical lesions (5.8 vs. 9.3 days, P = 0.002). We created a composite statistic, area-under-the-curve (AUC) of classical lesion size versus time. There was a reduction in the AUC in the combination arm compared with placebo (23 vs. 193 mm(2), P < 0.001). Adverse events were minimal. Secondary and posttreatment recurrences were not increased by combination therapy.conclusions: This pilot study supports the addition of topical corticosteroids to an oral antiviral agent for the treatment of HSL. Larger studies need to confirm the safety and efficacy of this approach.