| CTRI Number |
CTRI/2024/01/061349 [Registered on: 11/01/2024] Trial Registered Prospectively |
| Last Modified On: |
27/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to find the effect of Tofacitinib film forming lotion compared to mometasone solution in baldhead patients |
|
Scientific Title of Study
|
Clinical Evaluation of Efficacy and Safety of Tofacitinib Film Forming Topical Lotion 2% Versus Momate® Lotion (Mometasone Furoate Topical Solution 0.1% w v) in the Management of Patients with Alopecia Areata - An Open Label, Comparative, Active Controlled, Randomized, Parallel, Prospective, Multi-Center Clinical Study
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| HHCL/01-11/22, Version No. 1.0; Version date: 02-11-2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shoba jagdish chandra |
| Designation |
Head of the Department (HOD) |
| Affiliation |
Hetero Healthcare Limited |
| Address |
Department of clinical pharmacology and therapeutics, Hetero Healthcare Limited, Sy No. 80 84 Melange Towers, 4th floor, C-wing pratika Nagar, Madhapur
Hyderabad
TELANGANA
500081
India |
| Phone |
9704416425 |
| Fax |
|
| Email |
shobhaudutha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shoba jagdish chandra |
| Designation |
Head of the Department (HOD) |
| Affiliation |
Hetero Healthcare Limited |
| Address |
Department of clinical pharmacology and therapeutics, Hetero Healthcare Limited, Sy No. 80 84 Melange Towers, 4th floor, C-wing pratika Nagar, Madhapur
Hyderabad
TELANGANA
500081
India |
| Phone |
9704416425 |
| Fax |
|
| Email |
shobhaudutha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr P Narender reddy |
| Designation |
Clinical Research Associate II |
| Affiliation |
Hetero Healthcare Limited |
| Address |
Department of clinical pharmacology and therapeutics, Hetero Healthcare Limited, Sy No. 80 84 Melange Towers, 4th floor, C-wing pratika Nagar, Madhapur
Hyderabad
TELANGANA
500081
India |
| Phone |
9030343543 |
| Fax |
|
| Email |
narenderreddy.pdgla@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hetero Healthcare Limited, Sy No. 80 84 Melange Towers, 4th floor, C Wing Pratika Nagar, Madhapur, Hyderabad, 500 081
Telangana |
|
|
Primary Sponsor
|
| Name |
Hetero Healthcare Limited |
| Address |
Sy No. 80 84 Melange Towers, 4th floor, C Wing Pratika Nagar, Madhapur, Hyderabad, 500 081 Telangana |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Avula Rajamma |
ACSR Government Medical college and Hospital |
Assistant professor, DVL Department, Dargamitta, SPSR-524004.
Nellore
ANDHRA PRADESH |
9908773534
avularajamma@gmail.com |
| Dr Sharmila P Patil |
Dr D Y Patil Hospital |
Professor and Head of department, Department of Dermatology, OPD 54-55, Ayyappa Road, Dr D Y Patil Vidyanagar, Sector 5, Nerul. Navi mumbai 400706
Mumbai
MAHARASHTRA |
8850635503
drsharmilapatil@gmail.com |
| Dr Nipul Vallabhadas Vara |
Government Medical collge and Sir Sayajirao General Hospital (SSGH) |
Assistant Professor, Department of Dermatology, Ground floor,
Jail Road, Indira Avenue, Sayajigunj,
Vadodara - 390001
Vadodara
GUJARAT |
9426074084
nipulvara@gmail.com |
| Dr Vaggu Anand Kumar |
Krishna Institute of Medical Sciences Hospital |
Consultant Dermotologist, Cosmetologist, Department of Dermactology, Begumpet 1-8, 31/1, Minister Road, Krishna Nagar Cologny, Ramgopalpet, Secunderabad 500 003
Hyderabad
TELANGANA |
9885899341
anand2derma@yahoo.co.in |
| Dr M Roopa Shree |
Kurnool Medical College |
Assistant Professor, Department of DVL, Admnistrative Building, First floor, Room No 2, Budhawara
Peta, Kurnool-518002
Kurnool
ANDHRA PRADESH |
8374352104
mroopashree31@gmail.com |
| Dr EswariL |
Victoria Hospital |
Associate professor, Department of Dermatology, BMCRI, City Market, Fort Road,560002
Bangalore
KARNATAKA |
9845935375
eshwaril@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Ethics committee of BMCRI, Bangalore Medical college and Research Institute. |
Approved |
| IEC, Padamshree D. Y. Patel Medical College, Hospital & Research Centre |
Approved |
| Institutional Ethics Committee for Human Research, Department of Pharmacology, Medical College and SSG Hospital |
Approved |
| Institutional Ethics Committee, A C SUBBA REDDY GOVERNMENT MEDICAL COLLEGE AND HOSPITAL |
Approved |
| Institutional Ethics Committee, Kurnool Medical College/Govt.General Hospital |
Approved |
| KIMS Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
| Status |
| No Objection Certificate |
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L639||Alopecia areata, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Momate® Lotion (Mometasone Furoate Topical Solution 0.1% w/v) |
Lotion will be applied as a thin layer to the affected scalp area of hair loss once a day.
Duration of comparator agent has been for 12 weeks |
| Intervention |
Tofacitinib Film Forming Topical Lotion 2% w/v |
One ml will be applied twice daily at approximately 12-hour intervals (total daily dose of 2 mL) to the target scalp area of hair loss.
Duration of intervention has been for 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients aged 18 – 50 years of either gender with clinical diagnosis of alopecia areata.
2. Patients in good health with no evidence of systemic illness.
3. Willing to report response to treatment as per protocol during the study period.
4. Willing to give written informed consent. |
|
| ExclusionCriteria |
| Details |
1. Any subject who is currently experiencing significant spontaneous regrowth of terminal hair.
2. Any subject treated with a topical, intralesional or systemic agent likely to cause regrowth in alopecia areata within the past month.
3. Patients who concomitantly using systemic drugs (steroids, cytotoxic agents (methotrexate, azathioprine), vasodilators, antihypertensive agents, anticonvulsant drugs, beta-adrenergic receptor blockers, diuretics, spironolactone, diazoxide, cyclosporine, or ketoconazole.
4. Patients with H / O Tuberculosis or any serious illness.
5. H/ o hypersensitivity to study medication.
6. Participating in other clinical trials |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
- Change in SALT score
- Percent scalp hair regrowth based on extent of absolute hair loss (percent scalp hair regrowth based on extent of absolute hair loss. (percent scalp hair regrowth based on SALT score). |
Week 4, week 8 and week 12 (end of study) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Treatment Emergent Adverse Events (TEAEs) |
Week 4, Week 8 and Week 12 |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
18/01/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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)
|
This is an Open Label, Comparative, Active Controlled, Randomized, Parallel, Prospective, Multi-Center Clinical Study. The primary objective of this trial is to evaluate the clinical efficacy of Tofacitinib film forming topical lotion 2% as compared to Momate® Lotion (Mometasone Furoate Topical Solution USP 0.1% w/v) in the management of patients with alopecia areata. The secondary objective of this trial is to assess the safety of Tofacitinib film forming topical lotion 2% as compared to Momate® Lotion (Mometasone Furoate Topical Solution USP 0.1% w/v) in the management of patients with alopecia areata. |