None listed
Conditions
Interventions
Intervention1: Depiklen: Depiklen is a cream which contains rather plant derivatives or compounds which are non-synthetic.
It is to be used daily twice for 3 months
Control Intervention1: No comparato
Sponsors
Sante Mernaud Pharmaceuticals Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoints â?¢ Changes in score of the Melasma area and severity index (MASI) â?¢ Skin colour assessment using the Visual scale and with Instrument Timepoint: Visit 1 and Visit 5 | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Digital Photographic assessment â?¢ Physician global improvement assessment scores at baseline and week 12 â?¢ Patient satisfaction using grading scale â?¢ Melasma Quality of life questionnaire before and after the treatment. Timepoint: Visit 1 and Visit 5 | — |
Countries
India
Contacts
Public ContactVikram Baburao
Sante Mernaud Pharmaceuticals
Outcome results
None listed