Health Condition 1: null- Vitiligo
Conditions
Interventions
Intervention1: Application of Melbild Solution: Melbild solution should be applied daily at bedtime on target lesion followed in the morning with exposure to sunlight for 5-10 minutes between 11 am to
Sponsors
Alkem Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and Female subject in between 18 to 65 years of age 2. Subjects diagnosed with stable vitiligo (Stable vitiligo as no new significant macules and no progression of existing macules for >= 6 months) during the screening 3. Subjects with vitiligo lesion over Body Surface area 4. Subjects who have not received any treatment for vitiligo in the last 3 months 5. Subjects willing to visit the clinic as per the predefined schedule
Exclusion criteria
Exclusion criteria: 1. Subjects with known history of skin cancer 2. Subjects with known history of photosensitive disorders 3. Subjects with known history of major medical co-morbidities like serious cardiovascular/cerebral/renal/hepatic diseases 4. Subjects on systemic therapies for vitiligo in the last 3 months 5. Subjects on topical therapyâ??s e.g. steroids class 3 or stronger in the last 3 months. 6. Subjects who has undergone recent or concurrent phototherapy like Narrow Band -UVB phototherapy, PUVA etc. 7. Subject is of reproductive potential and is not using adequate contraceptive precautions, in the judgment of the investigator 8. Subject is pregnant or breast feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in extent of repigmentation in target lesion after 12 months of treatment from Melbild Solution plus Tacrolimus 0.1% Ointment versus Tacrolimus 0.1% Ointment aloneTimepoint: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Improvement in extent of repigmentation in target lesion after 6 months of treatment from Melbild Solution plus Tacrolimus 0.1% Ointment versus Tacrolimus 0.1% Ointment alone. 2. Improvement in Patient global evaluation of vitiligo 3. Incidence of Treatment Emergent AEs amongst both groups.Timepoint: 6 months and 12 months | — |
Countries
India
Contacts
Public ContactRahul Pathak
Senior Manager - Medical Affairs
Outcome results
None listed