CTRI Number |
CTRI/2023/12/060431 [Registered on: 01/12/2023] Trial Registered Prospectively |
Last Modified On: |
23/01/2025 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Drug |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
Comparing Tofacitinib and Tacrolimus Creams for Unstable Vitiligo Treatment |
Scientific Title of Study
|
A randomized study to compare the efficacy of topical tofacitinib versus topical tacrolimus in treatment of patients with unstable vitiligo |
Trial Acronym |
Nil |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Davinder Parsad |
Designation |
Professor |
Affiliation |
Post Graduate Institute of Medical Education and Research |
Address |
Room no 8 Level 2 Block F Nehru Hospital Post Graduate Institute of Medical Education and Research Sector 12 Chandigarh
Chandigarh CHANDIGARH 160012 India |
Phone |
7986359284 |
Fax |
|
Email |
parsad@mac.com |
|
Details of Contact Person Scientific Query
|
Name |
Davinder Parsad |
Designation |
Professor |
Affiliation |
Post Graduate Institute of Medical Education and Research |
Address |
Room no 8 Level 2 Block F Nehru Hospital Post Graduate Institute of Medical Education and Research Sector 12 Chandigarh
CHANDIGARH 160012 India |
Phone |
7986359284 |
Fax |
|
Email |
parsad@mac.com |
|
Details of Contact Person Public Query
|
Name |
Davinder Parsad |
Designation |
Professor |
Affiliation |
Post Graduate Institute of Medical Education and Research |
Address |
Room no 8 Level 2 Block F Nehru Hospital Post Graduate Institute of Medical Education and Research Sector 12 Chandigarh
CHANDIGARH 160012 India |
Phone |
7986359284 |
Fax |
|
Email |
parsad@mac.com |
|
Source of Monetary or Material Support
|
Post Graduate Institute of Medical Education and Research, Sector 12, Chandigarh |
|
Primary Sponsor
|
Name |
Post Graduate Institute of Medical Education and Research |
Address |
Sector 12 Chandigarh 160012 |
Type of Sponsor |
Research institution and hospital |
|
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 |
Dr Davinder Parsad |
Post Graduate Institute of Medical Education and Research, Chandigarh |
Room no 5009, Block C, Level 5, New OPD, PGIMER, Sector 12, Chandigarh Chandigarh CHANDIGARH |
7986359284
parsad@mac.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional 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 |
Topical Tacrolimus 0.1% ointment |
Topical Tacrolimus 0.1% ointment applied to vitiligo patches twice a day for 16 weeks |
Intervention |
Topical Tofacitinib 2% ointment |
Topical tofacitinib 2% ointment applied to vitiligo patches twice a day for 16 weeks |
|
Inclusion Criteria
|
Age From |
5.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
Consecutive patients with clinical diagnosis of vitiligo vulgaris and fulfilling the inclusion criteria listed below will be recruited for the study.
1. Participants aged 5 years and over with a diagnosis of non-segmental vitiligo, limited to approximately 10% or less of body surface area
2. At least two symmetrical vitiligo patches that have been active in the last 12 months (reported by the participant, or parent).
3. Participants should be willing to stop any other active therapies for their vitiligo at time of randomisation, be able to administer the treatments safely at home (able to follow the treatment instructions and children able to comply with the necessary precautions).
4. Participants also need to be willing and able to give informed consent (or parental/guardian consent in the case of children).
|
|
ExclusionCriteria |
Details |
1. Potential participants with segmental or universal vitiligo, vitiligo limited to areas contraindicated for treatment with potent topical corticosteroid (e.g., around the genitals)
2. Evidence of marked Koebner phenomenon (lesions appearing in sites of skin trauma) as such potential participants are likely to require urgent care.
3. Participants with a history of skin cancer, radiotherapy use or photosensitivity;
4. Women who are pregnant, breastfeeding or likely to become pregnant during the treatment period;
5. Those currently using immunosuppressive drugs, or involved in another clinical trial and those with allergy or contraindication to any of the drugs.
6. Potential participants are not randomised into the trial if the investigator feels that they are unable to follow the treatment instructions, or if children are unable to comply with the necessary safety precautions.
Patients receiving topical or systemic therapy of any form for vitiligo will be kept off treatment for 2 weeks prior to start of therapy (as a wash out period).
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Centralized |
Blinding/Masking
|
Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Proportion of patients reporting that their vitiligo is either ‘a lot less noticeable’ or ‘no longer noticeable’ in response to the question: ‘Compared with the start of the study, how noticeable is the vitiligo now? using the validated Vitiligo Noticeability Scale (VNS). |
16 weeks |
|
Secondary Outcome
|
Outcome |
TimePoints |
Onset of treatment response: assessed by participant & investigator for each patch of vitiligo. The question ‘Compared with the start of the study, has there been a change in the vitiligo patch?’ is asked, with the patient & investigator responding with one of the following: stayed the same, improved, got worse. |
week 4, week 8, week 12 & week 16 |
Repigmentation in each topographical area will be assessed by using Vitiligo Area Scoring Index (VASI) at every visit |
week 4, week 8, week 12 & week 16 |
Colour-match of Repigmentation: Somewhat Darker/Somewhat Lighter/Same
|
week 4, week 8, week 12 & week 16 |
Pattern of repigmentation: Diffuse/Peri-follicular/Peripheral/Combined
|
week 4, week 8, week 12 & week 16 |
Incidence of adverse effects |
week 4, week 8, week 12 & week 16 |
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="30" |
Phase of Trial
|
Phase 4 |
Date of First Enrollment (India)
|
01/12/2023 |
Date of Study Completion (India) |
31/12/2024 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
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
Modification(s)
|
Vitiligo is the commonest depigmenting skin disorder affecting people of all skin types and ethnicities. It is characterized by a selective and progressive loss of functioning melanocytes from epidermis resulting in white patches on the skin and occasionally mucosae as well. A number of treatment approaches have been tried but none of them has been universally accepted as the therapy of choice. Currently there is no cure or effective method to limit the spread of the disease. The topical calcineurin inhibitors tacrolimus (0.03% in children and 0.1% in adults) and pimecrolimus 1% are preferred to topical corticosteroids for patients with limited vitiligo involving the face or areas at high risk for skin atrophy (e.g., intertriginous areas, genitals). Individual case reports describing the efficacy and safety of topical JAKi including topical tofacitinib, topical ruxolitinib and topical brepocitinib are available. These have been tried in cases of segmental as well as non-segmental vitiligo. While topical tofacitinib and ruxolitinib had favorable outcomes, topical delgocitinib showed variable results. Most of the studies on topical JAKi in vitiligo are open label, uncontrolled studies in whom treatment has been tried in combination with other therapies. Larger randomized trials are needed to conclusively establish role of topical JAKi in management of vitiligo.
In this prospective randomised study, we intend to evaluate the efficacy and tolerability of topical tofacitinib and compare it with topical tacrolimus in 25 patients (50 patches) of limited vitiligo vulgaris with an actively spreading disease and satisfying other inclusion criterias. |