| CTRI Number |
CTRI/2025/10/095595 [Registered on: 03/10/2025] Trial Registered Prospectively |
| Last Modified On: |
19/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Comparative assessment of effectiveness and safety between topical mometasone and topical tofacitinib in patients with alopecia areata single patch a prospective, observational study |
|
Scientific Title of Study
|
Comparative study of efficacy and tolerability of topical 0.1 percent Mometasone furoate cream versus 2 percent Tofacitinib ointment in patients of Alopecia areata (single patch) in a tertiary care teaching hospital: A prospective, observational 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 Vaibhavi Kshirsagar |
| Designation |
Junior Resident |
| Affiliation |
GMC Nagpur |
| Address |
Department of Pharmacology government medical college nagpur
Nagpur
MAHARASHTRA
440027
India |
| Phone |
07798841512 |
| Fax |
|
| Email |
drkshirsagarvaibhavi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Punam Ashok Gosavi |
| Designation |
Associate Professor |
| Affiliation |
GMC Nagpur |
| Address |
Department of Pharmacology government medical college nagpur
Nagpur
MAHARASHTRA
440027
India |
| Phone |
9422579722 |
| Fax |
|
| Email |
gosavipunam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vaibhavi Kshirsagar |
| Designation |
Junior Resident |
| Affiliation |
GMC Nagpur |
| Address |
Department of Pharmacology government medical college nagpur
Nagpur
MAHARASHTRA
440027
India |
| Phone |
07798841512 |
| Fax |
|
| Email |
drkshirsagarvaibhavi@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Department of Health Research under MoHFW |
| Address |
Department of Health Research 2nd Floor , IRCS Building ,1, Delhi-110001 |
| Type of Sponsor |
Government funding agency |
|
|
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 Vaibhavi Kshirsagar |
GovernmentMedicalCollege,Nagpur |
Out Patient
Department No.41,
Department
ofDermatology,
HanumanNagar,
Ajni Rd,
MedicalChowk, Ajni,
Nagpur,Maharashtra
440003 Nagpur
MAHARASHTRA
Nagpur
MAHARASHTRA
Nagpur
MAHARASHTRA |
07798841512
drkshirsagarvaibhavi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC GMCNAGPUR |
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 |
| Intervention |
Topical
Tofacitinib |
The topical medication in this study group will be advised to be applied
once daily on affected lesion. The total period of study will be 24 weeks.
Follow up will be conducted after 2,4,8,12 weeks and at the end at week
24. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
NOT APPLICABLE |
|
| ExclusionCriteria |
| Details |
1) Multiple patches or diffuse alopecia.
2) History of autoimmune, systemic, or endocrine disorders (e.g., SLE, thyroid disease).
3)Current use of systemic immunosuppressants or corticosteroids.
4)Patient known for study drug hypersensitivity reaction.
• History of cancer.
• Positive tests for hepatitis B or C virus, tuberculin skin test, QuantiFERON TB test, and
human immunodeficiency virus.
• Pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The primary efficacy endpoint will be the
difference in the composite Severity of Alopecia
Tool (SALT) scale from baseline to 24 weeks. |
24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Safety assessment done by recording and
evaluating the spontaneously reported adverse events
by the participants.
2. To assess and compare patient’s quality of life
(QoL) using Dermatology Life Quality Index (DLQI)
from baseline to 24 weeks between two groups |
The secondary efficacy endpoint will be the
difference in the Dermatology Life Quality
Index (DQLI) from baseline to 24 weeks. |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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
|
N/A |
|
Date of First Enrollment (India)
|
02/11/2025 |
| 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)
Modification(s)
|
Not Applicable |
| 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
|
Title:
Comparative study of efficacy and tolerability of topical therapy with 0.1% Mometasone cream
versus 2 percent Tofacitinib ointment in patients of Alopecia Areata single patch in a tertiary care
teaching hospital A prospective observational study
Introduction:
Alopecia areata is a common autoimmune dermatosis characterized by non-scarring hair loss that can
affect social and psychological well-being It most often presents as single or multiple round or oval
patches Topical mometasone and topical tofacitinib are emerging nonsteroidal options targeting the
underlying autoimmune pathology Most available evidence compares each separately but head to head
comparator data is limited
Objectives:
Primary objective
To compare the efficacy of topical 2 percent Tofacitinib ointment versus 0.1% Mometasone cream
in patients of alopecia areata using Severity of Alopecia Tool SALT score from baseline to 24 weeks
Secondary objectives
To compare the tolerability of both treatments by monitoring for adverse drug reactions
To assess and compare patient quality of life using the Dermatology Life Quality Index DLQI at end of 24
weeks
Methodology:
a) Materials and Methods
This is a prospective observational comparative study to be conducted over a period of 24 months in a
tertiary care teaching hospital Patients diagnosed with single patch alopecia areata will be allocated to
either Group A topical 2 percent Tofacitinib ointment applied twice daily or Group B topical 0.1% Mometasone cream applied once daily for 24 weeks
b) Inclusion Criteria
Patients aged 18 to 50 years
Stable single patch alopecia areata of less than or equal to 5 cm size persisting for at least six months
Willingness to provide written informed consent
Treatment naive or with at least four weeks washout of prior topical or systemic AA therapy
c) Exclusion Criteria
Multiple patches or diffuse alopecia
History of autoimmune systemic or endocrine disorders
Current use of systemic immunosuppressants or corticosteroids
Known hypersensitivity to study drugs
History of cancer
Positive tests for hepatitis B or C HIV or tuberculosis
Pregnancy or lactation
d) Endpoints
Primary endpoint
Difference in composite SALT score from baseline to 24 weeks
Secondary endpoints
Incidence and severity of adverse effects
Change in DLQI between baseline and 24 weeks
e) Primary Outcome
Mean percentage improvement in patch area or SALT score at week 24
f) Secondary Outcomes
Number of patients achieving 60 percent or more regrowth
Improvement in DLQI score
Time to visible hair regrowth
Incidence of adverse events
Study Procedure:
Patients screened in dermatology OPD and those fulfilling inclusion and exclusion criteria are enrolled
after written informed consent Baseline demographic and clinical data including blood counts are
recorded Participants are randomly allocated to either group Each group is given the assigned
intervention for 24 weeks with in person follow up at weeks 2 8 and 24 and telephonic follow up at
weeks 4 and 12 SALT and DLQI scores are recorded by a dermatologist
Drug Availability:
Both medications are provided free of cost to study participants through the OPD pharmacy
Data Collection:
Demographic and clinical data including serial SALT and DLQI scores are recorded at each follow up Adverse events are monitored at each contact
Statistical Analysis:
Continuous variables are compared using students t test and categorical data using chi square or fishers
exact test Mann Whitney test is used for independent means and Friedmans test for within group SALT
score reduction P value less than 0 05 is considered statistically significant Analysis is performed using
Graph pad prism software
Ethical Consideration:
Expected Impact:
Institutional Ethics Committee approval is obtained Study is conducted as per Declaration of Helsinki
guidelines Participants rights to confidentiality and withdrawal are protected Written informed consent is
mandatory Drugs are provided at no cost
This study will provide comparative data on efficacy and safety of topical mometasone versus tofacitinib for
single patch alopecia areata thereby informing evidence based therapeutic choices in clinical practice |