Health Condition 1: L80- Vitiligo
Conditions
Interventions
Intervention1: Topical test product: A thin layer should be applied twice daily (morning and evening). The layer should completely cover the depigmented patches extending beyond the border.
Control In
Sponsors
ISISPHARMA
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male & Female trial participants in general good health. 2. Trial participants in the age group of 18-65 years (both ages inclusive). 3. Trial participants with Fitzpatrick phototypes III to V. 5. Participant has not received phototherapy within the past 3 months, has not used any topical vitiligo treatment within the past 4 weeks, and is not currently undergoing any vitiligo treatment prior to the Screening Visit. 6. Trial participants free of excessive hair, acne, cuts, abrasions, fissures, wounds, lacerations, or any other active skin conditions on the test sites as determined by the dermatologist. 7. Trial participants who agree not to use any other product/treatment/home remedies except the provided products during the study period. 8. Trial participants who agree not to initiate any new dietary supplements, herbal products, or over-the-counter medications targeting skin pigmentation during the study period. 9. Trial participants agree to not change their normal hygiene and cleansing routine such as increasing or decreasing shower frequency or changing the soap or cleanser they have been using safely for the 30 days prior to enrolment. 10. Trial participants willing to avoid direct sun exposure (Use umbrella, Cap, Hat if stepping out in direct sunlight). 11. Trial participants who agree not to carry out bleaching or any other cosmetic/dermatologic procedures (including facials, chemical peels, or laser treatments) during the study period. 12. Trial participants willing to give a voluntary written informed consent, photography release and agree to come for regular follow-up.
Exclusion criteria
Exclusion criteria: 1. Trial participant with any other signs of significant local irritation or skin disease at or near the target area. 2. Trial participant currently taking any medication, which the Investigator believes may influence the study outcomes. 3. Trial participant having clinically significant systemic or cutaneous disease, chronic illness or had major surgery in the last year. 4. Trial participants unwilling to discontinue other topical products for the study duration. 5. Trial participant allergic or sensitive to bar, cleansing products, cosmetics, creams/lotions, artificial jewellery or anything else. 6. Trial participants who are pregnant and lactating (self-declared). 7. Trial participants who are currently under/planning to start hormone replacement therapies (HRT) or hormonal birth control less than 3 months prior to the study entry. 8. Any condition or circumstance that, in the opinion of the investigator, would interfere with the participant s ability to comply with the study protocol. 9. Trial participants who are an employee of sponsor or CRO.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the efficacy of the investigational product in improving and promoting re-pigmentation in vitiligo-affected areas using Vitiligo Area Scoring Index (VASI) The efficacy will be assessed based on: Changes from baseline Comparison with placeboTimepoint: From enrollement till week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in VETF scores at defined study timepoints with comparison between investigational product and placebo.Timepoint: From enrollement till week 24;Difference between investigational and standard product in % repigmentation, VASI, and VETF changes at defined timepoints.Timepoint: From enrollement till week 24;Safety and tolerability of test product over the treatment period at defined study timepoints.Timepoint: From enrollement till week 24 | — |
Countries
India
Contacts
Public ContactSoniya wills
MS Clinical Research Pvt. Ltd
Outcome results
None listed