| CTRI Number |
CTRI/2025/07/091998 [Registered on: 30/07/2025] Trial Registered Prospectively |
| Last Modified On: |
29/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study and compare the effect of two drugs, tofacitinib vs dexamethasone in patients with vitiligo |
|
Scientific Title of Study
|
To compare the efficacy and safety of low dose tofacitinib versus oral corticosteroid (dexamethasone) mini pulse along with topical PUVAsol in stabilization and
repigmentation of cutaneous lesions in rapidly progressive vitiligo. An open label active controlled randomized study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Alka Yadav |
| Designation |
Postgraduate student |
| Affiliation |
All India Institute of Medical Science,AIIMS Rajkot |
| Address |
All India Institute of Medical Science,AIIMS Rajkot ,Khanderi, Para Pipaliya Pin- 360110
Rajkot
GUJARAT
360110
India |
| Phone |
9466068114 |
| Fax |
|
| Email |
alkayadavmbbs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yashdeep Singh Pathania |
| Designation |
Assistant professor |
| Affiliation |
All India Institute of Medical Science,AIIMS Rajkot |
| Address |
All India Institute of Medical Science,AIIMS Rajkot ,Khanderi, Para Pipaliya Pin- 360110
Rajkot
GUJARAT
360110
India |
| Phone |
|
| Fax |
|
| Email |
yashdeepsinghpathania@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Alka Yadav |
| Designation |
Postgraduate student |
| Affiliation |
All India Institute of Medical Science,AIIMS Rajkot |
| Address |
All India Institute of Medical Science,AIIMS Rajkot ,Khanderi, Para Pipaliya Pin- 360110
Rajkot
GUJARAT
360110
India |
| Phone |
9466068114 |
| Fax |
|
| Email |
alkayadavmbbs@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Alka Yadav |
| Address |
All India Institute of Medical Science,AIIMS Rajkot ,Khanderi, Para Pipaliya Pin- 360110 |
| 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 Alka Yadav |
AIIMS Rajkot All India Institute of Medical Sciences,Rajkot |
Room no 116,117 Dermatology OPD ,AIIMS Rajkot All India Institute of Medical Sciences,Rajkot,Khanderi,Parapipaliya Rajkot,Gujarat,-360006 India
Rajkot
GUJARAT |
9466068114
alkayadavmbbs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee AIIMS Rajkot All India Institute of Medical Sciences,Rajkot,Khanderi,Parapipaliya Rajkot,Gujarat,-360006 India |
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 |
Oral corticosteroid (dexamethasone) mini pulse |
Oral corticosteroid (dexamethasone) mini pulse
2.5 mg dexamethsone twice weekly with topical PUVAsol every alternate day for 3 months |
| Intervention |
oral low dose tofacitinib |
oral low dose tofacitinib 5 mg OD along with topical PUVAsol every alternate day for 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosis: Vitiligo patient with active disease i.e. VIDA 4+
2. Patients having vitiligo for more than 6 months.
3. Body surface area (BSA) involvement is less than 5 %
4. Participants must be adult of age group 18-60 years old
5. Any sex
6. Presenting to the Dermatology OPD.
7. Participants providing written informed consent. |
|
| ExclusionCriteria |
| Details |
1. Patients unwilling to give written informed consent to participate in the study.
2. Patients of vitiligo with other major dermatological ailments ( Immunobullous disease, SLE, Connective tissue diseases, Autoimmune diseases, Vasculitis).
3. Patients with underlying hepatic, renal diseases, coronary artery disease (CAD)
4. Patients with any major contraindications to the use of tofacitinib.
5. Pregnant, lactating female |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the number of patients achieving the arrest of progression of the disease i.e decrease of VIDA score by 1 point in low dose tofacitinib (Group A) and oral corticosteroid (dexamethasone) mini pulse (Group B.
2. To evaluate number of patients achieving more than 50 percent of repigmentation in each group. |
16 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the percentage of patients maintaining arrest of the disease in each group at 24 weeks.
2. To compare the patients achieving arrest of progression and repigmentation between the groups A and B at 16 and 24 weeks.
3. To evaluate change in mean VASI and mean Physician global assessment scores from baseline to end of 16 weeks and end of 24 weeks within and between groups A and B.
4. To analyse patient global assessment using patient satisfaction score and Patient reported outcome measures (PROM) VitiQoL at 16 and 24 weeks within and between group A and group B. |
at 16 and 24 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 3 |
|
Date of First Enrollment (India)
|
11/08/2025 |
| 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="2"
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
|
An open-label two-arm randomized prospective non inferior active controlled study with intention to treat to compare the efficacy and safety of low dose tofacitinib versus oral corticosteroid (dexamethasone) mini pulse along with topical PUVAsol in the stabilization and repigmentation of rapidly progressive vitiligo with Body surface area less than 5 percent.Vitiligo patient with active disease VIDA 4 and having vitiligo for more than 6 months adult of age group 18-60 years old of any sex, presenting to the Dermatology OPD and providing written informed consent. Patients unwilling to give written informed consent to participate in the study,with other major dermatological ailments (Immunobullous disease, SLE, Connective tissue diseases, Autoimmune diseases,Vasculitis),with underlying hepatic, renal diseases, coronary artery disease (CAD) or any major contraindications to the use of tofacitinib,Pregnant, lactating female will be excluded.Participants will be randomised using computer generated random number.Primary objectives are to evaluate the number of patients achieving the arrest of progression of the disease ,decrease of VIDA score by 1 point in low dose tofacitinib (Group A) and oral corticosteroid (dexamethasone) mini pulse (Group B) at 16 weeks.To evaluate number of patients achieving more than 50 percent of repigmentation in each group at 16 weeks.Secondary objectives are to evaluate the percentage of patients maintaining arrest of the disease in each group at 24 weeks.To compare the patients achieving arrest of progression and repigmentation between the groups A and B at 16 and 24 weeks.To evaluate change in mean VASI and mean Physician global assessment scores from baseline to end of 16 weeks and end of 24 weeks within and between groups A and B.To analyse patient global assessment using patient satisfaction score and Patient reported outcome measures (PROM) VitiQoL at 16 and 24 weeks within and between group A and group B. |