| CTRI Number |
CTRI/2025/04/084602 [Registered on: 11/04/2025] Trial Registered Prospectively |
| Last Modified On: |
06/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Role of topical tofacitinib in alopecia (hair loss). |
|
Scientific Title of Study
|
A comparative randomised controlled trial evaluating the efficacy of topical tofacitinib versus topical clobetasol propionate in localised alopecia areata.
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sukarna Saha |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Science, Jodhpur |
| Address |
Room no.-105,
Dermatology OPD, AIIMS Jodhpur, Basni, Jodhpur, Rajasthan, India
Jodhpur RAJASTHAN 342005 India |
| Phone |
9954129813 |
| Fax |
|
| Email |
sukarnasaha17425@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Anupama Bains |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
All India Institute of Medical Science, Jodhpur |
| Address |
Room no.-105,
Dermatology OPD, AIIMS Jodhpur, Basni, Jodhpur, Rajasthan, India
Jodhpur RAJASTHAN 342005 India |
| Phone |
7297895727 |
| Fax |
|
| Email |
doc.trinity@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Sukarna Saha |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Science, Jodhpur |
| Address |
Room no.-105,
Dermatology OPD, AIIMS Jodhpur, Basni, Jodhpur, Rajasthan, India
Jodhpur RAJASTHAN 342005 India |
| Phone |
9954129813 |
| Fax |
|
| Email |
sukarnasaha17425@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS Jodhpur, Basni, Jodhpur, Rajasthan, India, 342005 |
|
|
Primary Sponsor
|
| Name |
AIIMS Jodhpur |
| Address |
AIIMS Jodhpur, Basni, Jodhpur, Rajasthan, India, 342005 |
| Type of Sponsor |
Government medical college |
|
|
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 Sukarna Saha |
AIIMS Jodhpur |
Room no.-105,
Dermatology OPD, AIIMS Jodhpur, Basni, Jodhpur, Rajasthan, India Jodhpur RAJASTHAN |
09954129813
sukarnasaha17425@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L638||Other alopecia areata, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Efficacy of topical clobetasol propionate in localized alopecia areata. |
Patients with localized alopecia areata over scalp with SALT score S1, more than 5 years, having stable disease.Research question is whether topical tofacitinib is better than topical clobetasol propionate.Aim of study is to compare efficacy of topical tofacitinib versus topical clobetasol propionate in localized alopecia areata.Primary objective is to compare efficacy of topical tofacitinib versus topical clobetasol propionate in localised alopecia areata by Hair Regrowth Score.Secondary objective is to compare no. of patients having 50% improvement in RGS, percentage reduction in area involved with alopecia areata in both groups, quality of life of patients using DLQI, to compare side effects profile in both groups and to assess relapse.Patients will be given topical tofacitinib 2 percent ointment twice daily and topical clobetasol propionate 0.05 percent ointment twice daily to patients with age group more than 12 years and in age group 6-12 years,clobetasol is given twice a day for 4 weeks then once a day for 4 weeks then on alternate days for 4 weeks and twice a week for 4 weeks.Total duration of treatment is 4 months.Expected outcome will be assessed by clinical picture, trichoscopy, RGS, SALT at baseline and every visit.Study duration will be approximately 18 months. |
| Intervention |
Efficacy of topical tofacitinib versus in localized alopecia areata. |
Patients with localized alopecia areata over scalp with SALT score S1, more than 5 years, having stable disease.Research question is whether topical tofacitinib is better than topical clobetasol propionate.Aim of study is to compare efficacy of topical tofacitinib versus topical clobetasol propionate in localized alopecia areata.Primary objective is to compare efficacy of topical tofacitinib versus topical clobetasol propionate in localised alopecia areata by Hair Regrowth Score.Secondary objective is to compare no. of patients having 50% improvement in RGS, percentage reduction in area involved with alopecia areata in both groups, quality of life of patients using DLQI, to compare side effects profile in both groups and to assess relapse.Patients will be given topical tofacitinib 2 percent ointment twice daily and topical clobetasol propionate 0.05 percent ointment twice daily to patients with age group more than 12 years and in age group 6-12 years,clobetasol is given twice a day for 4 weeks then once a day for 4 weeks then on alternate days for 4 weeks and twice a week for 4 weeks.Total duration of treatment is 4 months.Expected outcome will be assessed by clinical picture, trichoscopy, RGS, SALT at baseline and every visit.Study duration will be approximately 18 months. |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients who are clinically diagnosed with
localized alopecia areata over scalp.
2. SALT score S1(less than 25 percent hair loss).
3. Age group more than 5 years.
4. Stable disease without appearance of new patch or increase in size of existing patch in last 15 days and without evidence of spontaneous hair regrowth. |
|
| ExclusionCriteria |
| Details |
1. Pregnant and lactating females.
2. Patients who have received any topical treatment within the last 2 weeks or systemic corticosteroids, immunosuppressants, or oral tofacitinib in the past month.
3. Patch with atrophy or active infection at the site of patch.
4. Alopecia totalis, alopecia universalis, ophiasis, sisaipho pattern and alopecia areata involving sites other than scalp.
5. Patients with history of HIV, Hep B, Hep C, TB, leucopenia, hepatic and renal impairment.
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hair regrowth score (RGS) at end of 4 months. |
Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Number of patients having more than 50% improvement in RGS score.
2. Percentage reduction in area involved with alopecia areata in both the groups.
3. Change in SALT score
4. DIMT classification for patterns of regrowth
5. Patient satisfaction score
6. Improvement in trichoscopy parameters
7Quality of life of patients using Dermatology Life Quality Index (DLQI)
8.Side effects in both groups.
9.To assess relapse (if any) in both the groups.
|
Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks |
|
|
Target Sample Size
|
Total Sample Size="52" Sample Size from India="52"
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)
|
21/04/2025 |
| 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="0" Months="10" 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
|
The study will be conducted amongst patients of localised alopecia areata attending Dermatology, Venereology and Leprology department, AIIMS Jodhpur. The study will be including patients who are clinically diagnosed with localised alopecia areata over scalp with SALT score S1(<25% hair loss) with age group >5 years, having stable disease without appearance of new patch or increase in size of existing patch in last 15 days and without evidence of spontaneous hair regrowth. Patients who are pregnant, lactating, who had received any topical in last 2 weeks or systemic corticosteroid, immunosuppressant or oral tofacitinib in past 4 weeks, Alopecia totalis, alopecia universalis, ophiasis, sisaipho and alopecia with sites other than scalp, history of HIV, Hepatitis C, Hepatitis B, Tuberculosis, hepatic and renal impairment will be excluded from the study. The research question is whether topical tofacitinib is better than topical clobetasol propionate in patients of alopecia areata in terms of efficacy. The aim of the study is to compare the efficacy of topical tofacitinib versus topical clobetasol propionate in localised alopecia areata. The primary objective is to compare the efficacy of topical tofacitinib versus topical clobetasol propionate in localised alopecia areata in terms of Hair Regrowth Score (RGS). The secondary objective is to compare the no. of patients having >50% improvement in RGS, % reduction in area involved with alopecia areata in both groups, quality of life of patients using DLQI, to compare the side effects profile in both the groups and to assess relapse (if any) in both the groups. Patients will be given topical tofacitinib 2% ointment twice daily and topical clobetasol propionate 0.05% ointment is given twice daily to patients with age group more than 12 years and in age group 6-12 years, clobetasol is given twice a day for 4 weeks then once a day for 4 weeks then on alternate days for 4 weeks and twice a week for 4 weeks. The total duration of treatment is 4 months. At every visit, expected outcome will be assessed by clinical picture, trichoscopy, RGS, SALT at baseline and every visit. The study duration will be approximately 18 months. |