Role of Melbild Solution in the treatment of Vitiligo
- Conditions
- Health Condition 1: null- Vitiligo
- Registration Number
- CTRI/2017/06/008845
- Lead Sponsor
- Alkem Laboratories Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 120
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 <= 10%
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
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
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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. <br/ ><br> <br/ ><br>2. Improvement in Patient global evaluation of vitiligo <br/ ><br> <br/ ><br>3. Incidence of Treatment Emergent AEs amongst both groups.Timepoint: 6 months and 12 months