| CTRI Number |
CTRI/2025/03/082382 [Registered on: 17/03/2025] Trial Registered Prospectively |
| Last Modified On: |
07/03/2025 |
| 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 study to compare the effectiveness of Topical Tofacitinib ointment combined with microneedling versus topical Tofacitinib ointment alone in patients of alopecia aerata |
|
Scientific Title of Study
|
A Hospital-based, Randomized Controlled Trial Comparing the Efficacy of topical 2 percent Tofacitinib ointment combined with microneedling versus topical percent ointment alone in 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 Rohit Singh Chauhan |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, Gorakhpur |
| Address |
Department of dermatology, Hospital block, AIIMS, Gorakhpur, Uttar Pradesh
Gorakhpur
UTTAR PRADESH
273001
India |
| Phone |
8887599407 |
| Fax |
|
| Email |
rohit987654321000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunil Kumar Gupta |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, Gorakhpuur |
| Address |
Department of dermatology, Hospital building, AIIMS, Gorakhpur, Uttar Pradesh
Gorakhpur
UTTAR PRADESH
273001
India |
| Phone |
9838844937 |
| Fax |
|
| Email |
dr.sunil_30@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunil Kumar Gupta |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, Gorakhpuur |
| Address |
Department of dermatology, Hospital building, AIIMS, Gorakhpur, Uttar Pradesh
Gorakhpur
UTTAR PRADESH
273001
India |
| Phone |
9838844937 |
| Fax |
|
| Email |
dr.sunil_30@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Gorakhpur, Uttar Pradesh, India, 273001 |
|
|
Primary Sponsor
|
| Name |
Dr Rohit Singh Chauhan |
| Address |
Room no 125, Boys resident hostel, AIIMS, Gorakhpur, Uttar Pradesh,273001 |
| 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 Rohit Singh Chauhan |
All India Institute of Medical Sciences, Gorakhpur |
Room no 226, Department of dermatology, Hospital block, AIIMS, Gorakhpur, Uttar Pradesh, 273001
Gorakhpur
UTTAR PRADESH |
8887599407
rohit987654321000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee, AIIMS, Gorakhpur |
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 |
Tofacitinib |
Topical 2 percent Tofacitinib ointment, one fingertip unit to be applied twice daily topically over alopecia patch for a period of 24 weeks |
| Intervention |
Tofacitinib with Microneedling |
Topical 2 percent Tofacitinib ointment, one fingertip unit to be applied twice daily topically over alopecia patch for 24 weeks and combined with microneedling sessions to be done every 4 weekly interval with 1.5 mm derma roller on the alopecia patch in similar 24 weeks period
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients between the age group of 18 to 50 yrs
Diagnosed with alopecia aerate exhibiting at least two patches of alopecia involving the scalp
No history of treatment with microneedling or within 1 month before enrollment in study
Willingness to adhere to the study protocol and attend follow-up visits
|
|
| ExclusionCriteria |
| Details |
Active scalp infections or skin diseases
systemic immunosuppressive or steroid therapy
Known hypersensitivity to tofacitinib or any other study components
Prior hair transplantation
Any coagulation disorder or thrombocytopenia
Patients having alopecia totalis and universalis
history of cancer or hepatitis B or C, tuberculin test or IGRA test and HIV virus positive patients
pregnant women and children more than 18 years of deranged biochemical profile
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Percentage improvement in the Severity of the alopecia tool score in both groups |
0, 24 weeks, 48 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Trichoscopic findings ( terminal hairs, white dots, black dots, exclaimation mark sign) |
0, 6th, 12th month |
| 2. Global photographic assessment at baseline, 6th month and 12th month and comparision between them |
o, 6th, 12th month |
| 3. Hair pull test and assessment at baseline, 6th month and 12th month and comparision between them |
0, 6th, 12th month |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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)
|
18/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
18/03/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 study is devised to compare the efficacy of topical 2% tofacitinib ointment combined with microneedling versus topical 2% tofacitinib alone in patients of alopecia areata over a 24-week treatment period. This study recruits a total of 74 patients willing to participate in the study after taking informed consent and divides into two groups each having a total number of 37 participants randomly. One group will be receiving topical 2% tofacitinib ointment twice daily to be applied over the alopecia patches on scalp combined with microneedling (using 1.5 mm dermaroller) to be done at every 4 weekly interval on alopecia patches for 24 weeks. While, other other group will only receive topical 2% tofacitinib ointment twice daily to be applied over the alopecia patches on scalp for 24 weeks. Each participants will be followed up regularly at 4 weekly interval for clinical assessment which will be recorded and to note any adverse effect if any to given therapy. At the end of 24 week outcomes will be compared in terms of percentage improvement in SALT score (severity of alopecia tool), trichoscopic findings(changes in scalp hair density, black dots, white dots, exclamation mark hairs), global photographic assessment and hair pull test in each group. Randomization will be done on the basis of computer generated randomization table with allocation concealment in opaque envelopes into above mentioned two groups. |