Efficacy and safety of a topical test product in adults with vitiligo (a long-term skin condition that results in pale white patches on the skin)
| ISRCTN | ISRCTN86347020 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86347020 |
| Sponsor | ISISPHARMA |
| Funder | ISISPHARMA |
- Submission date
- 14/11/2025
- Registration date
- 17/11/2025
- Last edited
- 14/11/2025
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Skin and Connective Tissue Diseases
Plain English summary of protocol
Background and study aims
Vitiligo is a chronic, acquired depigmenting disorder of the skin characterized by the selective destruction of melanocytes, leading to well-demarcated white patches.
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.
Who can participate?
Male and female between 18 and 65 years old with Fitzpatrick phototype III to V having non-segmental vitiligo.
What does the study involve?
Subjects are randomly allocated to apply on the vitiligo patches either the test product, or the placebo or the tacrolimus ointment 0.1%. Vitiligo patches are evaluated at baseline, week 6, week 12, week 18 and week 24.
What are the possible benefits and risks of participating?
The possible benefits are the repigmentation of vitiligo patches, stabilization of disease progression and improvement in patient-reported outcomes.
The test product contains ingredients approved for cosmetic usage and is found to be safe to be used on human skin.
Where is the study run from?
MS clinical research, Bangalore, India
When is the study starting and how long is it expected to run for?
Enrolment: 20 December 2025 till 6 April 2026, study expected completion date : October 2026
Who is funding the study?
ISISPHARMA (France)
Who is the main contact?
Joëlle AL CHOBOQ (ISISPHARMA), jalchoboq@isispharma.com
Contact information
Principal investigator
MS Clinical Research Pvt. Ltd
327/15 1st main road cambridge layout Ulsoor
Bangalore
560008
India
| Phone | + 91 9845044066 |
|---|---|
| mukta.sachdev@msclinical.com |
Scientific
MS Clinical Research Pvt. Ltd
327/15 1st main road cambridge layout Ulsoor
Bangalore
560008
India
| Phone | + 91 9945952952 |
|---|---|
| ritambhara@msclinical.com |
Public
MS Clinical Research Pvt. Ltd
327/15 1st main road cambridge layout Ulsoor
Bangalore
560008
India
| Phone | + 91 9759593715 |
|---|---|
| soniya@msclinical.com |
Scientific
ISISPHARMA, 78 rue de la villette
Lyon
69003
France
| Phone | +33 4 28 00 05 86 |
|---|---|
| jalchoboq@isispharma.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicenter interventional double-blinded randomized controlled trial |
| Secondary study design | Randomised parallel trial |
| Scientific title | 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 |
| Study objectives | Test product is effective and safe for vitiligo |
| Ethics approval(s) |
Approved 29/10/2025, ACE independent ethics committee (2nd floor B portion, Nandanam Building, No. 1, B Channasandra, OMBR 5th Main Road, Bangalore, 560043, India; + 91 63619 87546; aceiec13@gmail.com), ref: SKIN/IPVT/2025-01 |
| Health condition(s) or problem(s) studied | Non-segmental vitiligo |
| Intervention | Participants are randomized into 3 arms: Arm 1: 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. Arm 2: Placebo (A thin layer should be applied twice daily morning and evening). The layer should completely cover the depigmented patches extending beyond the border. Arm 3: Standard treatment, 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. For all study arms, the total duration of the treatment is 24 weeks with weekly follow-ups. Randomisation process: Computer generated randomisation. |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Degree of re-pigmentation in vitiligo-affected areas measured using dermatological, instrumental, and photographic evaluations using Vitiligo Area Scoring Index (VASI) at baseline, Week 6, week 12, week 18, week 24 |
| Key secondary outcome measure(s) |
1. Dermatological examination, instrumental measurements, and standardized photographic evaluation using VETF scores at baseline, Week 6, week 12, week 18, week 24 |
| Completion date | 31/10/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | All |
| Target sample size at registration | 105 |
| Key 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. |
| Key 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. |
| Date of first enrolment | 20/12/2025 |
| Date of final enrolment | 30/03/2026 |
Locations
Countries of recruitment
- India
Study participating centre
Bangalore
560008
India
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Editorial Notes
14/11/2025: Trial's existence confirmed by ACE independent ethics committee.
