CTRI Number |
CTRI/2025/03/083363 [Registered on: 25/03/2025] Trial Registered Prospectively |
Last Modified On: |
24/03/2025 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Drug |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
A clinical study to evaluate the effect and safety of Topical Tacrolimus and Topical Tofacitinib ointments for treatment in patchy loss of skin pigmentation. |
Scientific Title of Study
|
An open label, randomized, comparative, study to evaluate efficacy, safety and remission period of Topical Tacrolimus 0.1 percent ointment and Topical Tofacitinib 2 percent ointment in patients with focal vitiligo. |
Trial Acronym |
NIL |
Secondary IDs if Any
|
Secondary ID |
Identifier |
IIS/2025/01 Version 1.0 dated 19-Feb-2025 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Vishalakshi Viswanath |
Designation |
Medical director |
Affiliation |
DISHA Skin and Laser Institute |
Address |
Department of Dermatology, DISHA Skin and Laser Institute, room no.101, Srushti Prime, Gokhale Rd, Naupada, Thane West
Thane MAHARASHTRA 400602 India |
Phone |
9324086679 |
Fax |
|
Email |
visha1967@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Vishalakshi Viswanath |
Designation |
Medical director |
Affiliation |
DISHA Skin and Laser Institute |
Address |
Department of Dermatology, DISHA Skin and Laser Institute, room no.101, Srushti Prime, Gokhale Rd, Naupada, Thane West
Thane MAHARASHTRA 400602 India |
Phone |
9324086679 |
Fax |
|
Email |
visha1967@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Vishalakshi Viswanath |
Designation |
Medical director |
Affiliation |
DISHA Skin and Laser Institute |
Address |
Department of Dermatology, DISHA Skin and Laser Institute, room no.101, Srushti Prime, Gokhale Rd, Naupada, Thane West
Thane MAHARASHTRA 400602 India |
Phone |
9324086679 |
Fax |
|
Email |
visha1967@gmail.com |
|
Source of Monetary or Material Support
|
Glenmark Pharmaceuticals Limited. Glenmark House, B. D. Sawant Marg, Chakala,Andheri (E), Mumbai – 400099 |
|
Primary Sponsor
|
Name |
Dr Vishalakshi Viswanath |
Address |
DISHA Skin and Laser Institute, Department of Dermatology, room no. 101, Srushti Prime, Gokhale Rd, Naupada, Thane West, Maharashtra 400602 |
Type of Sponsor |
Other [self] |
|
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 Vishalakshi Viswanath |
DISHA Skin and Laser Institute |
Department of Dermatology, room no 101, Srushti Prime, Gokhale Rd, Naupada, Thane West, Maharashtra 400602 Thane MAHARASHTRA |
9324086679
visha1967@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Suraksha-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 |
Intervention |
Topical Tacrolimus 0.1% ointment |
Twice a day for 12 weeks |
Comparator Agent |
Topical Tofacitinib 2% ointment |
Twice a day for 12 weeks |
|
Inclusion Criteria
|
Age From |
2.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
Patients eligible for enrolment in the study must meet all of the following criteria:
1. Male or female subjects aged between 02-65 years with focal vitiligo.
2. Patients with minimum of 2 lesions Excluding mucosal lesions with minimum patch size of 8 to 12 cm2 with involvement of less than 10% BSA, present on areas of face, trunk and upper limb.
3. No serious health conditions that may interfere with the study
4. The parent, guardian of child should give written Parental Consent form, Assent form, Informed Consent Form for participation in study. |
|
ExclusionCriteria |
Details |
Patients meeting any of the following criteria must not be enrolled in the study:
1. History of skin disease or presence of skin condition that would interfere with the study assessments.
2. Any clinically significant medical condition that would, in the opinion of the investigator, put the subject at undue risk or interfere with interpretation of study results.
3. Known hypersensitivity to tacrolimus, tofacitinib or any of the excipients used in the formulation.
4. Subject who have taken any treatment for vitiligo (systemic, topical or phototherapy) for 14 days prior to being randomized. |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
1. Percentage of Patients with achievement of VASI-75 or complete re-pigmentation at the end of Week 12.
2. Percentage of patients who shows relapse after achieving VASI 75. (relapse of vitiligo is defined as appearance of new lesions or increase in extent of existing lesions)
3. Percentage of patients who show relapse within 16 weeks follow-up of achieving VASI 75. |
1. Upto 12 weeks
2. From 12th week to 28th week
3. From 12th week to 28th week |
|
Secondary Outcome
|
Outcome |
TimePoints |
1. Incidence of Treatment Emergent Adverse Events till end of the study.
2. Evaluation of cutaneous tolerability in terms of redness, erythema, dryness, scaling, and burning/irritation sensation till end of the study. |
1. Upto 28 weeks
2. Upto 28 weeks |
|
Target Sample Size
|
Total Sample Size="70" Sample Size from India="70"
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
|
Phase 4 |
Date of First Enrollment (India)
|
05/04/2025 |
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="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
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
|
This is an open label, randomized, comparative, investigator initiated study to evaluate efficacy, safety and remission rate with Topical Tacrolimus 0.1% ointment vs Topical Tofacitinib 2% ointment in Indian patients with focal vitiligo. This study is planned in 70 Indian patients. Each patient will undergo 12 weeks of treatment period and further 16 weeks of follow up. Efficacy assessment will be done at all visits till week 12 and safety assessment will be done through out the study duration. |