Clinical Trial Details (PDF Generation Date :- Tue, 15 Jan 2019 07:37:18 GMT) CTRI Number Last Modified On 26/03/2012 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2012/03/002520 [Registered on: 26/03/2012] - Trial Registered Retrospectively No Interventional Drug Randomized, Parallel Group, Active Controlled Trial A clinical trial to know the abnormal respone of cortisol secretion following topical clobetasol propionate cream application in patients with psoriasis A Multicenter, Randomized, Investigator Blind, Parallel Group, Three Arm Pilot Study To Evaluate The HPA Axis Suppression, Efficacy And Safety Of Clobetasol Propionate Cream 0.025% Formulation 5 And Clobetasol Propionate Cream 0.025% Formulation 13 As Compared To Temovate E Emollient 0.05% (clobetasol propionate emollient cream) In Patients With Moderate To Severe Psoriasis For 28 Days Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) CDS1002 Protocol Number Details of Principal Investigator Dr Manjunath Shenoy MD dermatology Phone 08242204670 Fax 08242202193 Department of Dermatology, Yenepoya Medical College, Derelakatte 575018 manjunath576117@gmail.com Details Contact Person (Scientific Query) Dr Girisha R Medical Monitor Manipal Acunova Phone 08066915700 Fax 08066915782 Manipal Acunova, SJR i park, EPIP Zone, Mobius tower, whitefield 560066 girisha.r@ecronacunova.com Details Contact Person (Public Query) Shashimohan Keelara Project Manager Manipal Acunova Manipal Acunova, SJR i park, EPIP Zone, Mobius tower, whitefield 560066 page 1 / 5
Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Details of Ethics Committee Phone 9686576204 Fax 08066915805 > Dr. Reddy's Laboratories shashimohan.keelara@ecronacunova.com Source of Monetary or Material Support Primary Sponsor Details Dr Reddys Laboratories 7-1-27, Ameerpet Hyderabad, AP 500 016 Type of Sponsor NIL List of Countries of Principal Investigator Pharmaceutical industry-n NIL of Site Site Phone/Fax/ Dr. Jayesh Kothari Kothari Skin Clinic #301, Manas Bhavan, RNT Marg,-452001 Indore MADHYA PRADESH Dr. Rizwan Haq Radiance Skin Clinic Opp. Muslim Library, Tekdi Road, Sadar,,-440001 Nagpur MAHARASHTRA Dr.D.N. Balraj Rajbal Skin Clinic 944/1, 7th Main, 80 Feet Road, Subbayanapalya, Banaswadi,-560043 Dr. Sandesh Gupta Skin & Laser Center F-12/10, Krishna Nagar,-110051 New Delhi DELHI Dr. Frederick Manuel Skin Clinic No.22, Paper Mills Road, Perambur,-600011 Chennai TAMIL NADU Dr. Manjunath Shenoy Yenepoya Medical College Department of Dermatology, Yenepoya Medical College, Derelakatte,-575018 0731 2513392 0731 2513392 kotharidrjayesh@gmail. com 0712 3210803 0712 2551957 drrizwanhaq@yahoo.co.in 080 65683667 dnbalraj@rediffmail.co m 011 22092115 011 2209 2115 drsandeshg@rediffmail. com 044 26201305 skinfred@hotmail.com 0824 2204670 0824 2202193 manjunath576117@gm ail.com of Committee Approval Status Date of Approval Is Independent Ethics Committee? CHL Apollo hospital EC Approved 15/11/2010 No CLINICOM, for Radiance Skin Clinic CLINICOM, for Rajbal Skin Clinic page 2 / 5
Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria CLINICOM, for skin & Laser center CLINICOM, for Skin Clinic Yenepoya university ethics committee Status Approved 23/11/2010 No Date Approved/Obtained 23/03/2011 Health Type Patients Condition Psoriasis Type Details Intervention Clobetasol propionate 0.025% 3.5 g Twice daily, topical for 28 days Comparator Agent Temovate E 3.5 g Twice daily, topical for 28 days Age From Age To Gender Details 18.00 Year(s) 99.00 Year(s) Both Inclusion Criteria 1.Male and female patients of at least 18 years of age, with a clinical diagnosis of moderate to severe psoriasis. 2.Patient must have moderate to severe psoriasis with at least 25% Body Surface Area (BSA) involvement at Screening and Baseline. The patient can have involvement on scalp, face, groin, axillae, and/or other intertriginous areas but the 25% should not include these areas. 3.Patients must have Psoriasis Global Assessment (PGA) score of at least 3 (moderate) or more at Screening and Baseline for the overall disease severity. 4.Patients whose results from the Screening cortisol response test that are considered normal and show no evidence of any abnormal HPA function or adrenal response (screening visit ACTH test). 5.Female, if of child bearing potential - a.must use efficacious and reliable method of contraception during the entire duration of the study {e.g. double barrier methods (e.g., condom and spermicide); IUD} or remain sexually inactive throughout the study. b.must have a negative urine pregnancy test at Screening and Baseline (test must have a sensitivity of at least 25mIU/ml for hcg). c.must be non-lactating. 6.Patients must demonstrate their willingness to participate in the study and comply with the study procedures and required visits. 7.Have the ability to understand and sign a written informed consent form, which must be completed prior to study specific tasks being performed. 8.Must be willing to authorize use and disclosure of protected health information collected for the study. Exclusion Criteria Details Exclusion Criteria 1.Females who are pregnant or lactating or planning to become pregnant during the study period. 2.Patients with known hypersensitivity to clobetasol propionate or Temovate E or any of the ingredients of the test drugs (see Section 4) 3.Patients who have used any corticosteroid within 4 weeks of the page 3 / 5
Screening visit. 4.Patients with known history of acute adrenal crisis, Addisons disease or decreased adrenal output, low pituitary function, or pituitary tumors. 5.Patient has a history of an adverse reaction to Cosyntropin (injection) or similar test reagents. 6.Patients whose psoriasis involves only the scalp, face, groin, axillae, and/or other intertriginous areas. 7.Patient has current diagnosis of types of psoriasis other than stable plaque psoriasis (i.e. acute, guttate, erythrodermic, exfoliative or pustular psoriasis) 8.Patient has a history of psoriasis that has been unresponsive to topical corticosteroid therapy. 9.Patients taking or applying topical or systemic treatments likely to interfere with either psoriasis status or HPA axis function 10.Use of any of following by the patient: a.currently receiving or has received any radiation therapy, anti-neoplastic agents or immunosuppressant medication within 4 weeks prior to the first dose of study drug. b.undergone treatment with any systemic or photo antipsoriatic therapy within 8 weeks of the first dose of study drug. c.treated within 12 weeks (or five half lives whichever is less) prior to the first dose of study drug with any biological therapies for psoriasis. d.used any topical antipsoriatic agents of any kind or any topical corticosteroids for any reason within 2 weeks prior to Screening visit. 11.In the Investigators opinion, the patient has other dermatological conditions, such as atopic or contact dermatitis, that may interfere with the clinical assessments of the signs and symptoms of psoriasis 12.Patients with a serious and/or uncontrolled medical condition (chronic or active liver disease, renal impairment, heart disease, diabetes, severe respiratory disease, rheumatoid arthritis, current malignancies, immunocompromised conditions or any other disease) that in the opinion of the investigator would interfere with the study or place the patient at unacceptable risk. 13.Patients with a history or examination findings of alcohol dependence, alcohol or drug abuse or suspected abuse. 14.Patients who have participated in a study of an investigational drug 30 days prior to the Screening Visit. Method of Generating Random Sequence Method of Concealment Blinding/Masking Computer generated randomization Sequentially numbered, sealed, opaque envelopes Investigator Blinded Primary Outcome Outcome Timepoints The proportion of subjects with abnormal cortisol response level at Day 28 (i.e. cortisol 18 ug/100 ml). 28 Days Secondary Outcome Outcome Timepoints Target Sample Size Phase of Trial Phase 2 Date of First 25/04/2011 The proportion of subjects with abnormal plasma cortisol at each time point ( 5 ug/100 ml). Total Sample Size=90 Sample Size from =90 7 days page 4 / 5
Powered by TCPDF (www.tcpdf.org) PDF of Trial Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary No Date Specified Years=0 Months=6 Days=0 Not Applicable Open to Recruitment This is a 28-day prospective, randomized, active-controlled, investigator blind, parallel group three arm pilot study. The main objective of the study is to evaluate the effect of twice daily use of clobetasol propionate cream 0.025% (2 different formulations) on HPA axis suppression in patients with moderate to severe psoriasis. page 5 / 5