Health Condition 1: null- Vitiligo
Conditions
Interventions
Intervention1: 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 3 pm.
Control
Sponsors
Alkem Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Either male or female with stable (Stable vitiligo defined as no new significant macules and no progression of existing macules for >= 6 months) vitiligo in between 18 to 65 years of age 2. Subjects of vitiligo involving the face, trunk, limbs, with or without mucosal involvement (Patient with body surface area 20% to 40%) 3. Subjects who have not received any treatment in the last 3 months 4. Subjects willing to give informed consent. 5. Subjects willingness 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 with classically vitiligo affecting resistance areas like elbows, hands, knees, and feet 8. Subject is of reproductive potential and is not using adequate contraceptive precautions, in the judgment of the investigator 9. Subject is pregnant or breast feeding 10. Subjects for whom investigator has concerns regarding the subject &ability to comply with the protocol procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in extent of repigmentation in target lesion after 6 months of treatment from Melbild Solution plus PUVA versus PUVA aloneTimepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in Patient global evaluation of vitiligoTimepoint: 6 months;Incidence of Treatment Emergent AEs amongst both groupsTimepoint: 6 months | — |
Countries
India
Contacts
Public ContactRahul Pathak
Medical Advisor
Outcome results
None listed