A Clinical Study to assess the efficacy and safety of Depiklen Depigel for the treatment of hyper-pigmentation disorders in adults
- Registration Number
- CTRI/2012/08/002897
- Lead Sponsor
- Sante Mernaud Pharmaceuticals Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
•Males and females of age group 18-60 years
•Subjects who are willing to give written informed consent.
•Subjects with Fitzpatrick Skin types II to IV
•Subjects with hyper pigmentation disorders such as Melasma and lentigo (mild to moderate).
•Patient is willing and able to comply with all trial requirements
•Having major treatment, including topical hydroquinone or tretinoin, cryotherapy, electro-surgery, trichloroacetic acid application, laser or intense pulsed light, in the 3 months before the beginning of the study
•Past history of allergy to whitening cosmetic products
•Past history of atopic dermatitis
•Habit of going to the tanning salon or frequent sun exposure longer than 4 hours per day
•Present history of mental diseases
•Previous participation in a clinical trial within 6 months.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary endpoints <br/ ><br>â?¢Changes in score of the Melasma area and severity index (MASI) <br/ ><br>â?¢Skin colour assessment using the Visual scale and with Instrument <br/ ><br>Timepoint: Visit 1 and Visit 5
- Secondary Outcome Measures
Name Time Method â?¢Digital Photographic assessment <br/ ><br>â?¢Physician global improvement assessment scores at baseline and week 12 <br/ ><br>â?¢Patient satisfaction using grading scale <br/ ><br>â?¢Melasma Quality of life questionnaire before and after the treatment. <br/ ><br>Timepoint: Visit 1 and Visit 5