CTRI

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CTRI Number

CTRI/2024/02/063353 [Registered on: 29/02/2024] Trial Registered Prospectively

Last Modified On:

22/02/2024

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug

Study Design

Randomized, Parallel Group, Multiple Arm Trial

Public Title of Study

Effect of oral tofacitinib and oral methylprednisolone mini-pulse and combination of both in alopecia areata.

Scientific Title of Study

To compare the efficacy and adverse effects of oral tofacitinib and oral methylprednisolone mini-pulse and combination of both in treatment of alopecia areata: A Randomized Controlled Trial.

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 Satyendra Kumar Singh
Designation	Professor
Affiliation	Institute of Medical Sciences Banaras Hindu University
Address	Department of Dermatology Institute of Medical Sciences Banaras Hindu University Varanasi- 221005 Varanasi UTTAR PRADESH 221005 India
Phone	9198120582
Fax
Email	drsatyendraderma@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Satyendra Kumar Singh
Designation	Professor
Affiliation	Institute of Medical Sciences Banaras Hindu University
Address	Department of Dermatology Institute of Medical Sciences Banaras Hindu University Varanasi- 221005 UTTAR PRADESH 221005 India
Phone	9198120582
Fax
Email	drsatyendraderma@gmail.com

Details of Contact Person
Public Query

Name	Dr Bhagirath Bhakar
Designation	Junior Resident
Affiliation	Institute of Medical Sciences Banaras Hindu University
Address	Department of Dermatology Institute of Medical Sciences Banaras Hindu University Varanasi- 221005 Department of Dermatology Institute of Medical Sciences Banaras Hindu University Varanasi- 221005 Varanasi UTTAR PRADESH 221005 India
Phone	9116267937
Fax
Email	bhagirathbhakar1998@gmail.com

Source of Monetary or Material Support

Institute of medical sciences, BHU, Varanasi

Primary Sponsor

Name	Institute of Medical Sciences BHU
Address	Institute of Medical Sciences Banaras Hindu University Varanasi- 221005
Type of Sponsor	Government medical college

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 Satyendra Kumar Singh	Sir Sunderlal Hospital BHU	Sir Sunderlal Hospital Department of Dermatology, OPD number-207, Banaras Hindu University Varanasi- 221005 Varanasi UTTAR PRADESH	9198120582 drsatyendraderma@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

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: L639\|\|Alopecia areata, unspecified,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	methylprednisolone	Oral methylprednisolone 32 mg on two consecutive days per week for 4 months
Intervention	tofacitinib	Oral tofacitinib 5 mg twice daily for 4 months
Comparator Agent	tofacitinib and methylprednisolone	Oral tofacitinib 5 mg twice daily and oral methylprednisolone 32 mg on two consecutive days per week for 4 months

Inclusion Criteria

Age From	18.00 Year(s)
Age To	65.00 Year(s)
Gender	Both
Details	1. Clinically diagnosed cases of alopecia areata with severity of alopecia tool (SALT) score of 10 % or over. 2. Age: 18 to 65 years 3. Patients not taking systemic drug in last 1 month and topical treatment in last 15 days. - All participants who give consent for the study

ExclusionCriteria

Details

1. Patients having history or active tuberculosis.
2. Patients with Pregnancy and lactating mother.
3. Patients with uncontrolled renal, hepatic,
hematological or heart disease.
4. Patients with diabetes mellitus and hypertension.

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
Reduction in severity of alopecia tool (SALT) score by 90%	Reduction in severity of alopecia tool (SALT) score by 90% which will assessed monthly for 4 months.

Secondary Outcome

Outcome	TimePoints
Reduction in severity of alopecia tool (SALT) score by 50% & reduction in severity of alopecia tool (SALT) score by 100%	Reduction in severity of alopecia tool (SALT) score by 50% & reduction in severity of alopecia tool (SALT) score by 100% which will be assessed monthly for 4 months.

Target Sample Size

Total Sample Size="219"
Sample Size from India="219"
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)

01/03/2024

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="1"
Months="0"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

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

All patients aged 18 to 65 years diagnosed clinically with alopecia areata coming to Dermatology OPD, SSH, BHU those who fulfill the inclusion criteria will be included in the study. All patients will be randomized equally in three groups.

Group A will be given tofacitinib 5 mg BD with supportive treatment (proton pump inhibitor, calcium and vitamin D) for 4 months.

Group B will be given oral methylprednisolone 32 mg on two consecutive days per week with supportive treatment (proton pump inhibitor, calcium and vitamin D) for 4 months.

Group C will be given both tofacitinib 5 mg BD and oral methylprednisolone 32 mg on two consecutive days per week with supportive treatment (proton pump inhibitor, calcium and vitamin D) for 4 months.

All patients will be followed every month for 7 months and response evaluation will be done by severity of alopecia tool (SALT) score. End point of treatment will be complete regrowth of hair or 4 months of treatment whichever achieved first.