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1 Clinical Trial Details (PDF Generation Date :- Sat, 06 Apr :04:47 GMT) CTRI Number Last Modified On 27/11/2018 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2013/02/ [Registered on: 25/02/2013] - Trial Registered Prospectively No Interventional Drug Randomized, Parallel Group, Active Controlled Trial To Evaluate and compare effect and skin safety of Clobetasol gel (Clobetasol Propionate USP 0.05% w/w) and Clobetasol Cream (Clobetasol Propionate BP 0.05% w/w) in patients with mild to moderate psoriasis Evaluation and comparison of efficacy and in use skin safety of Clobetasol gel (Clobetasol Propionate USP 0.05% w/w) and Clobetasol Cream (Clobetasol Propionate BP 0.05% w/w) in patients with mild to moderate psoriasis Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) CL/029/1212/STU Version No.: 2 of 31st January 2013 Protocol Number Details of Principal Investigator Dr RG Torsekar Principal Investigator Phone SHRI RATNAKAR CLINIC SHRI RATNAKAR CLINIC Everest Shopping Centre, 3rd Floor, Opposite Railway Station, Thane nandutorse@yahoo.com Details Contact Person (Scientific Query) Dr RG Torsekar Principal Investigator SHRI RATNAKAR CLINIC SHRI RATNAKAR CLINIC Everest Shopping Centre, 3rd Floor, Opposite Railway Station, Details Contact Person (Public Query) Phone nandutorse@yahoo.com Details Contact Person (Public Query) Ms Prachi Parihar Saxena Manager, Strategy and Business Development Curatio Healthcare Pvt. Ltd. Curatio Healthcare Pvt. Ltd. 78/88 Defence Officers Colony, Nandambakkam, Chennai Chennai TAMIL NADU page 1 / 5

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Details of Ethics Committee Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Phone prachi@curatiohealthcare.com Source of Monetary or Material Support > Curatio Healthcare Pvt. Ltd. 78/88 Defence Officers Colony, Nandambakkam, Chennai Primary Sponsor Details Curatio Healthcare Pvt Ltd 8/88 Defence Officers Colony, Nandambakkam, Chennai Type of Sponsor NIL List of Countries of Principal Investigator Pharmaceutical industry-n NIL of Site Site Phone// Dr Suneel Vartak Dr. Suneel Vartak Skin Clinic Flat No. 112, B-Wing, Rajan Complex, Above Annapurna Sweets, Datta Mandir Chowk, Nashik Road Nashik Dr R Torsekar SHRI RATNAKAR CLINIC Everest Shopping Centre, 3rd Floor, Opposite Railway Station, Dombivali (W) Thane Thane Dr Vinay Saraf Skin & Laser Clinic 109, Jawahar Nagar, Road No. 1, Goregaon (W), suneel.vartak@gmail.co m nandutorse@yahoo.co m drvsaraf@yahoo.com of Committee Approval Status Date of Approval Is Independent Ethics Committee? Clinical Ethics Forum, Clinical Ethics Forum, Status Not Applicable Health Type Patients Approved 12/02/2013 Yes Approved 20/03/2013 Yes Date No Date Specified Condition mild to moderate Psoriasis Type Details Intervention Clobetasol Gel (Clobetasol Apply Vaseline Petroleum Jelly Propionate USP 0.05% w/w with over the affected areas. Apply Tetrahydropiperine 0.5% ) approximately gms of page 2 / 5

3 Inclusion Criteria Comparator Agent Age From Age To Gender Details Tenovate Cream (Clobetasol Propionate BP 0.05% w/w) Year(s) Year(s) Both Inclusion Criteria Clobetasol Gel (Clobetasol Propionate USP 0.05% w/w with Tetrahydropiperine 0.5%)sufficient to produce a uniform thin film over the entire lesion being tracked,twice that is in the morning and at night before going to bed. Massage with fingertips for 30 seconds. Duration of Application: 1 month Apply Vaseline Petroleum Jelly over the affected areas. Apply approximately gms of Tenovate Cream (Clobetasol Propionate BP 0.05% w/w) sufficient to produce a uniform thin film over the entire lesion being tracked,twice that is in the morning and at night before going to bed. Massage with fingertips for 30 seconds. Duration of Application: 1 month 1. Voluntary men/women with clinically diagnosed mild to moderate stable, chronic, plaque psoriasis At least one, discrete, well circumscribed lesion approximately 20 cm2 80 cm2 on trunk separated from adjacent lesions by at least 3 cms.the same lesion will be tracked through the entire study. 3. Age between years 4. Not on treatment for psoriasis- oral since 1 month and topical since 2 weeks. 5. Accepting not to use products with the same end benefit during the entire study duration. 6. Cooperating, informed of the need and duration of the examinations, and ready to comply with protocol procedures. 7. Having signed a Consent Form and will be informed orally and in writing of all information concerning the study procedures and study objectives. Exclusion Criteria Details Exclusion Criteria 1. Pustular psoriasis, Palmoplanter and erythrodermic psoriasis. 2. Pregnant women (as confirmed by UPT) and lactating women. 3. History of allergic dermatitis or contact allergy to cosmetics, 4. Hypersensitivity to any cosmetic product, raw material. 5. For whom the Investigator considers that he/she will not be compliant with study procedures. 6. Any clinically significant systemic or cutaneous disease, which may interfere with study treatments or procedures. 7. Subjects on any medical treatment either systemic or topical which may interfere with the performance of the study treatment (presently or in the past 1 month). 8. Subject in an exclusion period or participating in another similar cosmetic or therapeutic trial. Method of Generating Computer generated randomization page 3 / 5

4 Random Sequence Method of Concealment Blinding/Masking Other Participant and Investigator Blinded Primary Outcome Outcome Timepoints Clinical Evaluation using LASI scale. Day 0, 10 days,20 days and 30 days Secondary Outcome Outcome Timepoints Target Sample Size Phase of Trial Phase 4 Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary In use skin safety of Clobetasol gel (Clobetasol Propionate USP 0.05% w/w) and Clobetasol Cream (Clobetasol Propionate BP 0.05% w/w). Total Sample Size=36 Sample Size from =36 25/02/2013 No Date Specified Years=0 Months=1 Days=0 Not Applicable Completed Day 0, 10 days,20 days and 30 days This is a test under supervision of dermatologist, multricentric, double blinded, randomized, comparative versus initial state and each other. At Visit 1 Day 0, lesion will be clinically evaluated using the LASI scale and digital photographs will be taken. Evaluation for in use skin safety will be done at Visit 2 (10 days), Visit 3 (20 Days) and Visit 4 (30 days). Clinical evaluation and digital photographs will be taken at all visits. All photographs will be taken in such a manner that the identity of the volunteer would not be revealed. page 4 / 5

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