| CTRI Number |
CTRI/2025/11/097581 [Registered on: 17/11/2025] Trial Registered Prospectively |
| Last Modified On: |
17/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Topical product] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Study of a topical product to help improve vitiligo (a long-term skin condition that results in pale white patches on the skin) in adults. |
|
Scientific Title of Study
|
A Randomized, Double-Blind, Placebo-
Controlled, Multicentred Study to
Evaluate the Efficacy and Safety of a
Topical Test Product in Trial
Participants with Non-Segmental
Vitiligo. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SKIN/IPVT/2025-01 version 1.0, Dated 11 sep 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mukta Sachdev |
| Designation |
Principal investigator |
| Affiliation |
MS Clinical Research Pvt. Ltd |
| Address |
327/15
1st main road
cambridge layout Ulsoor
Bangalore
KARNATAKA
560008
India |
| Phone |
9845044066 |
| Fax |
|
| Email |
mukta.sachdev@msclinical.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ritambhara |
| Designation |
Director business and operations |
| Affiliation |
MS Clinical Research Pvt. Ltd |
| Address |
327/15
1st main road
cambridge layout Ulsoor
Bangalore
KARNATAKA
560008
India |
| Phone |
9945952952 |
| Fax |
|
| Email |
ritambhara@msclinical.com |
|
Details of Contact Person
Public Query
|
| Name |
Soniya wills |
| Designation |
Manager operations |
| Affiliation |
MS Clinical Research Pvt. Ltd |
| Address |
327/15
1st main road
cambridge layout Ulsoor
Bangalore
KARNATAKA
560008
India |
| Phone |
9759593715 |
| Fax |
|
| Email |
soniya@msclinical.com |
|
|
Source of Monetary or Material Support
|
| ISISPHARMA, 29 avenue de la marne, Parc des 3 chênes, 59290, WASQUEHAL |
|
|
Primary Sponsor
|
| Name |
ISISPHARMA |
| Address |
29 Avenue de la Marne
Parc des 3 chênes
59290 WASQUEHAL
France |
| Type of Sponsor |
Other [Dermocosmetic industry] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Mukta Sachdev |
MS Clinical Research Pvt. Ltd |
Department of Skin Sciences, #324, Second Floor, 1st Main Road, Cambridge Layout, Ulsoor
36-1, Second Floor, 1st Main Road, Cambridge Layout, Ulsoor
Bangalore
KARNATAKA |
9845044066
mukta.sachdev@msclinical.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACE independent ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L80||Vitiligo, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
A thin layer should be applied twice daily (morning and evening). The layer should completely cover the depigmented patches extending beyond the border. |
| Comparator Agent |
Tacrolimus ointment 0.1% |
A thin layer should be applied twice daily (morning and evening). The layer should completely cover the depigmented patches extending beyond the border. |
| Intervention |
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. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
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 placebo |
From enrollement till week 24 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change from baseline in VETF scores at defined study timepoints with comparison between investigational product and placebo. |
From enrollement till week 24 |
| Difference between investigational and standard product in % repigmentation, VASI, and VETF changes at defined timepoints. |
From enrollement till week 24 |
| Safety and tolerability of test product over the treatment period at defined study timepoints. |
From enrollement till week 24 |
|
|
Target Sample Size
|
Total Sample Size="105"
Sample Size from India="105"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="3" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Vitiligo is a chronic, acquired depigmenting disorder of the skin characterized by the selective destruction of melanocytes, leading to well-demarcated white patches. It affects approximately 0.5–2% of the global population and can occur at any age, with a multifactorial etiology involving genetic, autoimmune, oxidative stress, and neurogenic factors.
Non-segmental vitiligo (NSV), the most common clinical form, is typically bilateral and symmetrical, with lesions that may progress over time and involve multiple body sites. NSV is considered an autoimmune condition, often associated with other autoimmune diseases, and is characterized by an unpredictable course with periods of stability and activity. This study aims to evaluate the therapeutic efficacy of the test product in non-segmental vitiligo (NSV), with specific focus on the extent of repigmentation, stabilization of disease progression, and improvement in patient-reported outcomes. |