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CTRI Number  CTRI/2013/02/003430 [Registered on: 25/02/2013] Trial Registered Prospectively
Last Modified On: 27/11/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   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 
Scientific Title of Study   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 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
CL/029/1212/STU Version No.: 2 of 31st January 2013  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr RG Torsekar 
Designation  Principal Investigator 
Affiliation  SHRI RATNAKAR CLINIC 
Address  SHRI RATNAKAR CLINIC Everest Shopping Centre, 3rd Floor, Opposite Railway Station,

Thane
MAHARASHTRA
421202
India 
Phone  9820338816  
Fax    
Email  nandutorse@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr RG Torsekar 
Designation  Principal Investigator 
Affiliation  SHRI RATNAKAR CLINIC 
Address  SHRI RATNAKAR CLINIC Everest Shopping Centre, 3rd Floor, Opposite Railway Station,


MAHARASHTRA
421202
India 
Phone  9820338816  
Fax    
Email  nandutorse@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Ms Prachi Parihar Saxena 
Designation  Manager, Strategy and Business Development 
Affiliation  Curatio Healthcare Pvt. Ltd. 
Address  Curatio Healthcare Pvt. Ltd. 78/88 Defence Officers Colony, Nandambakkam, Chennai

Chennai
TAMIL NADU
600032
India 
Phone  914442633357  
Fax    
Email  prachi@curatiohealthcare.com  
 
Source of Monetary or Material Support  
Curatio Healthcare Pvt. Ltd. 78/88 Defence Officers Colony, Nandambakkam, Chennai 600032  
 
Primary Sponsor  
Name  Curatio Healthcare Pvt Ltd 
Address  8/88 Defence Officers Colony, Nandambakkam, Chennai 600032  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Suneel Vartak   Dr. Suneel Vartak   Skin Clinic Flat No. 112, B-Wing , Rajan Complex, Above Annapurna Sweets , Datta Mandir Chowk, Nashik Road-422 101
Nashik
MAHARASHTRA 		 2466268

suneel.vartak@gmail.com 
Dr R Torsekar  SHRI RATNAKAR CLINIC  Everest Shopping Centre, 3rd Floor, Opposite Railway Station, Dombivali (W)- 421 202. Thane
Thane
MAHARASHTRA 		 9820338816

nandutorse@yahoo.com 
Dr Vinay Saraf  Skin & Laser Clinic   109, Jawahar Nagar, Road No. 1, Goregaon (W), Mumbai-62
Mumbai
MAHARASHTRA 		 9821238668

drvsaraf@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Clinical Ethics Forum, Mumbai  Approved 
Clinical Ethics Forum, Mumbai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  mild to moderate Psoriasis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Clobetasol Gel (Clobetasol Propionate USP 0.05% w/w with Tetrahydropiperine 0.5% )  Apply Vaseline Petroleum Jelly over the affected areas. Apply approximately 0.25-0.5 gms of 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  
Comparator Agent  Tenovate Cream (Clobetasol Propionate BP 0.05% w/w)  Apply Vaseline Petroleum Jelly over the affected areas. Apply approximately 0.25-0.5 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  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1. Voluntary men/women with clinically diagnosed mild to moderate stable, chronic, plaque psoriasis.
2. 2. 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 18 – 55 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.
 
 
ExclusionCriteria 
Details  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 Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   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 
In use skin safety of Clobetasol gel (Clobetasol Propionate USP 0.05% w/w) and Clobetasol Cream (Clobetasol Propionate BP 0.05% w/w).  •Day 0, 10 days,20 days and 30 days 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
Final Enrollment numbers achieved (Total)= "28"
Final Enrollment numbers achieved (India)="28" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   25/02/2013 
Date of Study Completion (India) 28/05/2013 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  


  • 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.

 
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