CTRI/2025/11/097722 [Registered on: 20/11/2025] Trial Registered Prospectively
Last Modified On:
20/11/2025
Post Graduate Thesis
Yes
Type of Trial
Observational
Type of Study
Follow Up Study
Study Design
Other
Public Title of Study
A study to compare the efficacy of topical Tacrolimus cream and topical Tofacitinib ointment in patients with alopecia areata single patch
Scientific Title of Study
Comparative study of efficacy and tolerability of topical therapy with 0.03% Tacrolimus cream versus 2% 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 Sayali Rodge
Designation
Junior Resident
Affiliation
GMC Nagpur
Address
Department of Pharmacology, Government Medical College,Medical chowk Nagpur,Maharashtra
Nagpur MAHARASHTRA 440003 India
Phone
09284244063
Fax
Email
sayalirodge18899@gmail.com
Details of Contact Person Scientific Query
Name
Dr Punam Gosavi
Designation
Associate Professor
Affiliation
GMC Nagpur
Address
Department of Pharmacology, Government Medical College, Medical Chowk, Nagpur
Nagpur MAHARASHTRA 440003 India
Phone
09284244063
Fax
Email
gosavipunam@gmail.com
Details of Contact Person Public Query
Name
Dr Sayali Rodge
Designation
Junior Resident
Affiliation
GMC Nagpur
Address
Department of Pharmacology, Government Medical College, Medical chowk, Nagpur
Nagpur MAHARASHTRA 440003 India
Phone
09284244063
Fax
Email
sayalirodge18899@gmail.com
Source of Monetary or Material Support
Department of Dermatology, GMC Nagpur, Medical Chowk, Nagpur, 440003
Primary Sponsor
Name
Department of Health Research under MoHFW
Address
Department of Health Research 2nd Floor, IRCS Building, 1, Red Cross Road,New Delhi - 110001
Type of Sponsor
Government funding agency
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 1
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Sayali Rodge
GovernmentMedicalCollege,Nagpur
Out Patient Department No.41, Department ofDermatology, HanumanNagar, Ajni Rd, MedicalChowk, Ajni, Nagpur,Maharashtra 440003
Nagpur
MAHARASHTRA Nagpur MAHARASHTRA
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.
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
• Multiple patches or diffuse alopecia.
• History of autoimmune, systemic, or endocrine disorders (e.g., SLE, thyroid disease).
• Current use of systemic immunosuppressants or corticosteroids.
• 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.
At the end of 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)
05/12/2025
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)
Not Yet Recruiting
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
Title of the Study Comparative study of efficacy and tolerability of topical therapy with 0.03 percent Tacrolimus 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. It has an unpredictable relapsing course, impacts quality of life and is associated with genetic and immunological factors. Standard therapy includes corticosteroids and topical tacrolimus. Janus kinase inhibitors such as tofacitinib are emerging as effective alternatives. Few head to head studies are available hence this study is planned
Purpose of the Study To compare the efficacy and tolerability of topical 2 percent tofacitinib ointment versus 0.03 percent tacrolimus cream in single patch alopecia areata patients
Objectives Primary objective To compare efficacy using Severity of Alopecia Tool SALT score from baseline to 24 weeks
Secondary objectives 1 To compare tolerability by recording adverse drug reactions 2 To assess and compare quality of life using Dermatology Life Quality Index DLQI at 24 weeks
Methodology a Materials and Methods Prospective observational comparative study conducted in Department of Dermatology at GMC Nagpur for 24 months June 2025 to May 2027. Patients with single patch alopecia areata will be enrolled
b Inclusion Criteria Age 18 to 50 years Stable single patch alopecia areata for at least 6 months patch size less than or equal to 5 cm Treatment naive or washed out from prior treatment for 4 weeks Written informed consent
c Exclusion Criteria Multiple or diffuse patches History of autoimmune systemic or endocrine disorders Use of systemic immunosuppressants Known hypersensitivity to study drugs History of cancer positive serology for HBV HCV HIV or latent TB Pregnant or lactating women
d Endpoints Primary endpoint Change in composite SALT score from baseline to 24 weeks Secondary endpoints Safety assessed by adverse events and change in DLQI score
e Outcomes Primary outcome Improvement in SALT score and percentage hair regrowth Secondary outcomes Incidence of adverse effects and improvement in DLQI score
Study Procedure Screening and diagnosis by dermatologist informed consent taken allocation into two groups Group A topical 2 percent tofacitinib twice daily Group B topical 0.03 percent tacrolimus once daily. Duration 24 weeks follow up at 2 8 and 24 weeks in person and 4 12 weeks telephonically. Efficacy assessed by SALT score tolerability by adverse event reporting and QoL by DLQI
Drug Availability Drugs will be provided free of cost through hospital OPD no financial burden on participants
Final Synopsis Sayali-AA Tofa v…
Data Collection Demographics baseline clinical parameters SALT score DLQI recorded at baseline and follow ups. Data entered in case record form and analysed
Statistical Analysis Continuous variables analysed using Student t test categorical variables with Chi square or Fisher exact test p value less than 0.05 considered significant. Mann Whitney and Friedman test used for intra and inter group comparisons. Analysis by Graph Pad Prism v8.4.2
Ethical Considerations Conducted as per Declaration of Helsinki GCP guidelines IEC approval obtained written informed consent confidentiality maintained right to withdraw ensured
Expected Impact The study is expected to provide comparative evidence on efficacy and tolerability of topical tofacitinib versus tacrolimus in alopecia areata and guide clinical decision making for better patient outcomes