| CTRI Number |
CTRI/2024/12/078575 [Registered on: 24/12/2024] Trial Registered Prospectively |
| Last Modified On: |
03/08/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study to compare 2 percent tofacitinib cream and calcipotriol 0.005 percent ointment in patchy hair loss over scalp |
|
Scientific Title of Study
|
A comparative study on clinical efficacy of Topical Tofacitinib 2 percent cream versus Topical Calcipotriol 0.005 percent ointment in the treatment of 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 |
DR NEHA KHAN |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
ERA S LUCKNOW MEDICAL COLLEGE AND HOSPITAL |
| Address |
Department of dermatology Era’s Lucknow Medical College and Hospital Sarfarazganj Lucknow, Uttar pradesh
Lucknow
UTTAR PRADESH
226003 India Department of dermatology Era’s Lucknow Medical College and Hospital Sarfarazganj Lucknow, Uttar pradesh
Lucknow
UTTAR PRADESH
226003 India Lucknow UTTAR PRADESH 226003 India |
| Phone |
9599915229 |
| Fax |
|
| Email |
kneha8302@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DR KSHITIJ SAXENA |
| Designation |
Professor |
| Affiliation |
Era’s Lucknow Medical College and Hospital |
| Address |
Department of dermatology Era’s Lucknow Medical College and Hospital Sarfarazganj Lucknow, Uttar pradesh
Lucknow
UTTAR PRADESH
226003 India
Lucknow UTTAR PRADESH 226003 India |
| Phone |
9208015391 |
| Fax |
|
| Email |
drkshitijsaxena@live.com |
|
Details of Contact Person Public Query
|
| Name |
DR NEHA KHAN |
| Designation |
Junior resident |
| Affiliation |
ERA S LUCKNOW MEDICAL COLLEGE AND HOSPITAL |
| Address |
Department of dermatology Era’s Lucknow Medical College and Hospital Sarfarazganj Lucknow, Uttar pradesh
Lucknow
UTTAR PRADESH
226003 India Department of dermatology Era’s Lucknow Medical College and Hospital Sarfarazganj Lucknow, Uttar pradesh
Lucknow
UTTAR PRADESH
226003 India Lucknow UTTAR PRADESH 226003 India |
| Phone |
859574206 |
| Fax |
|
| Email |
Kneha8302@gmail.com |
|
|
Source of Monetary or Material Support
|
| Era s lucknow medical college and hospital Sarfarazganj Lucknow, Uttar Pradesh 226003 India |
|
|
Primary Sponsor
|
| Name |
ERAS LUCKNOW MEDICAL COLLEGE AND HOSPITAL |
| Address |
Department of dermatology Era s lucknow medical college and hospital Sarfarazganj Lucknow, Uttar pradesh, 22600 |
| Type of Sponsor |
Private 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 NEHA KHAN |
Era Lucknow medical college and hospital Lucknow |
Department of dermatology Room No.2 Era s lucknow medical college and hospital Sarfarazganj Lucknow, Uttar Pradesh 226003
Lucknow
UTTAR PRADESH Lucknow UTTAR PRADESH |
9599915229
kneha8302@gmail.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: L639||Alopecia areata, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CALCIPOTRIOL 0.005% OINTMENT |
Calcipotriol Dose-0.005%
Frequency-Twice Daily Route- Topical application over the affected area Follow up- 4weeks, 8weeks,12weeks, 16weeks
Duration of study- 16 weeks
after completion of trial period, treatment of patient with the drug shall continue if necessary. |
| Intervention |
TOFACITINIB 2% CREAM |
Tofacitinib Dose-2% Frequency-Twice Daily Route- Topical application over the affected area
Follow up- 4weeks, 8weeks,12weeks, 16weeks
Duration of study- 16weeks
after completion of trial period, treatment of patient with the drug shall continue if necessary. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
All consenting patients of alopecia areata with SALT score less than 25% scalp involvement of either gender aged 18 years and above visiting in Dermatology OPD
|
|
| ExclusionCriteria |
| Details |
Patients who have taken any form of treatment in past 3 months
Immunocompromised patients or patients on immunosuppressive therapy will be excluded
Pregnant or lactating mothers
Patient with a history of hypersensitivity to tofacitinib or calcipotriol
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess and compare the efficacy of topical tofacitinib cream (2%) and topical calcipotriol ointment (0.005%) in promoting hair regrowth and minimizing disease progression in individuals with alopecia areata |
4 weeks,8 weeks,12 weeks, 16 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To analyse the efficacy of tofacitinib cream (2%) in alopecia areata.
To analyse the efficacy of calcipotriol ointment (0.005%) in alopecia areata.
To analyse potential side effects & patient’s tolerability associated with the use of topical tofacitinib cream (2%) & topical calcipotriol ointment (0.005%). |
4 weeks,8weeks,12weeks,16weeks |
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
12/01/2025 |
| Date of Study Completion (India) |
27/02/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="3" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
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)
|
Background: The search for effective treatment of Alopecia areata is ongoing. In the recent years JAK inhibitors and Calcipotriol have emerged as two promising treatment modalities. Objective: To evaluate and compare the therapeutic efficacy of tofacitinib cream (2%) and calcipotriolointment (0.005%) in the treatment of alopecia areata. Methods: A total of 100 alopecia areata patients were enrolled. All the patients were thoroughly examined for severity of disease using SALT scores and were randomized to receive either 2% Tofacitinib cream (n=50; mean age 28.44 years; 44% urban residents; 82% multiple patches) or 0.005% Calcipotriol ointment (n=50; mean age 26.26 years; 50% males; 84% multiple patches). Followed up was done at 4 weekly intervals upto 16 weeks. Data was statistically analyzed. Data was statistically analyzed. Results: At baseline the two groups had a comparable demographic and clinical profile. Mean SALT scores were 21.66±2.25 and 20.43±3.98 respectively in Tofacitinib and Calcipotriol groups. Significant reductions in mean SALT scores were observed from the first follow-up itself. At the last follow-up, mean reduction in SALT scores was 11.82±2.15 (53.65%) in Tofacitinib and 5.40±1.36 (26.41%) in Calcipotriolgroup. At all the follow-up intervals, mean SALT scores were significantly lower in Tofacitinib as compared to that in Calcipotriol group. Complete response rate was better in Tofacitinib than in Calcipotriol group. No major adverse effect was noted. There was no significant difference between two groups with respect to adverse drug reactions at any of the follow-up intervals. Conclusion: Tofacitinib was a better alternative than Calcipotriol.
|