| CTRI Number |
CTRI/2026/03/105339 [Registered on: 05/03/2026] Trial Registered Prospectively |
| Last Modified On: |
03/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparision of the efficacy of Dermaroller with Methotrexate 1 Percent gel and that of Clobetasol Propionate 0.05 Percent ointment in the treatment of Scalp Alopecia Areta |
|
Scientific Title of Study
|
A Study Of Efficacy And Safety Of Microneedle Transdermal Delivery Of Methotrexate 1 Percent Gel Versus Microneedle Transdermal Delivery Of Clobetasol Propionate 0.05 Percent Ointment In The Treatment Of Scalp 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 Rajashekar T S |
| Designation |
Professor, Department of Dermatology, Sri Devaraj Urs Medical College |
| Affiliation |
Sri Devaraj Urs Medical College |
| Address |
Room no 26, Department of Dermatology, R L Jalappa Hospital, Sri Devaraj Urs Medical College, Tamaka, Kolar
KARNATAKA
Kolar
KARNATAKA
563101
India |
| Phone |
9448316136 |
| Fax |
|
| Email |
rajashekardermat@sduaher.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Callista Juneja |
| Designation |
Junior Resident |
| Affiliation |
Sri Devaraj Urs Medical College, Tamaka, Kolar |
| Address |
Room no 26, Department of Dermatology, R L Jalappa Hospital, Sri Devaraj Urs Medical College, Tamaka, Kolar
KARNATAKA
Kolar
KARNATAKA
563101
India |
| Phone |
09987754235 |
| Fax |
|
| Email |
callistajuneja@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Callista Juneja |
| Designation |
Junior Resident |
| Affiliation |
Sri Devaraj Urs Medical College, Tamaka, Kolar |
| Address |
Room no 26, Department of Dermatology, R L Jalappa Hospital, Sri Devaraj Urs Medical College, Tamaka, Kolar
KARNATAKA
Kolar
KARNATAKA
563101
India |
| Phone |
09987754235 |
| Fax |
|
| Email |
callistajuneja@gmail.com |
|
|
Source of Monetary or Material Support
|
| RL Jalappa Hospital, Sri Devaraj Urs Medical College, Tamaka, Kolar |
|
|
Primary Sponsor
|
| Name |
Dr Rajashekar T S |
| Address |
Department of Dermatology, Sri Devaraj Urs Medical College, Kolar, Karnataka, 563101 |
| 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 Rajashekar T S |
RL Jalappa Hospital, Sri Devaraj Urs Medical College |
Room no 26,Department of
Dermatology,RL Jalappa Hospital,Sri Devaraj Urs Medical
College,Kolar,Karnataka
Kolar
KARNATAKA |
9448316136
rajashekardermat@sduaher.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Devaraj Urs Medical College, Institutional Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L639||Alopecia areata, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
MICRONEEDLE TRANSDERMAL DELIVERY OF CLOBETASOL PROPIONATE 0.05% OINTMENT |
for maximum 8 weeks at 2 weeks interval |
| Intervention |
MICRONEEDLE TRANSDERMAL DELIVERY OF METHOTREXATE 1% GEL |
for maximum 8 weeks at 2 weeks interval |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients of both genders of age more than 18 years with Localised Scalp Alopecia Areata |
|
| ExclusionCriteria |
| Details |
1.Active systemic infection or localized scalp infection requiring systemic therapy.
2.Severely Immunocompromised.
3.Uncontrolled comorbidities like Diabetes Mellitus
4.Pregnancy.
5.Patients who have undergone treatment with other modalities in past 6 weeks
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Measurement of efficacy of modalities on the basis of quartile grading scale
2.Lesional Area and Density Score
3.Severity TRichoscopy Index Alopecia Areata
4.Patient satisfaction using Likert Satisfaction Scale |
at baseline
every 2 weeks
at end of 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| post procedural side effects of Methotrexate 1% gel and Clobetasol Propionate 0.05% Ointment with Microneedle Transdermal Delivery |
at baseline
every 2 weeks
at end of 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
14/03/2026 |
| 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="0"
Months="6"
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
|
This study is to determine the efficacy of Microneedle Transdermal delivery of Methotrexate 1% Gel versus Microneedle Transdermal delivery of Clobetasol Propionate 0.05% Ointment in treatment of Scalp Alopecia Areata. As of now, no study has been done to compare these groups. Thus making this study a first of its kind. |