| CTRI Number |
CTRI/2023/10/058818 [Registered on: 18/10/2023] Trial Registered Prospectively |
| Last Modified On: |
16/10/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study comparing topical Methotrexatel with topical steroids in alopecia areata |
|
Scientific Title of Study
|
A Randomized comparative study of the efficacy of topical methotrexate gel 1%
versus topical betamethasone diproprionate lotion in the treatment of localized 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 Amrit Malik |
| Designation |
Junior Resident |
| Affiliation |
Mahatma Gandhi Medical College and Hospital |
| Address |
Chamber no.1, Department of Dermatology Venerology and
Leprology, Mahatma Gandhi Medical College RIICO Industrial area,
Tonk Road, Sitapura Jaipur
Jaipur
RAJASTHAN
302022
India
Jaipur
RAJASTHAN
302022
India |
| Phone |
9811122900 |
| Fax |
|
| Email |
amrit.malik259@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manisha Nijhawan |
| Designation |
Professor and HOD |
| Affiliation |
Mahatma Gandhi Medical College and Hospital |
| Address |
Chamber no.1, Department of Dermatology Venerology and
Leprology, Mahatma Gandhi Medical College RIICO Industrial area,
Tonk Road, Sitapura Jaipur
Jaipur
RAJASTHAN
302022
India
Jaipur
RAJASTHAN
302022
India |
| Phone |
9314503401 |
| Fax |
|
| Email |
m.nijhawan12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amrit Malik |
| Designation |
Junior Resident |
| Affiliation |
Mahatma Gandhi Medical College and Hospital |
| Address |
Chamber no.1, Department of Dermatology Venerology and
Leprology, Mahatma Gandhi Medical College RIICO Industrial area,
Tonk Road, Sitapura Jaipur
Jaipur
RAJASTHAN
302022
India
Jaipur
RAJASTHAN
302022
India |
| Phone |
9811122900 |
| Fax |
|
| Email |
amrit.malik259@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatama Gandhi Medical College, RIICO industrial area, Sitapura, Tonk Road, Jaipur
Rajasthan 302022 |
|
|
Primary Sponsor
|
| Name |
Amrit Malik |
| Address |
Chamber no. 1, Dept of Dermatology , Venerology and Leprology,
Mahatama Gandhi Medical College, RIICO industrial area, Sitapura,
Tonk Road, Jaipur Rajasthan 302022 |
| 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 Amrit Malik |
Mahatma Gandhi Hospital, Jaipur |
Room no. 1,
Department of Dermatology, venerology and leprology Mahatma Gandhi Hospital, RIICO Industrial area sitapura
Jaipur
RAJASTHAN |
9811122900
amrit.malik259@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Mahatma Gandhi Medical College and Hospital Jaipur |
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 |
betamethasone diproprionate 0.05% lotion |
topical application of betamethasone diproprionate 0.05% lotion in localised alopecia areata patch given twice daily for local application for 12 weeks or appearance of vellous hair whichever comes earlier |
| Intervention |
methotrexate 1 % gel |
topical application of methotrexate 1 % gel in localised patch of alopecia areata
Given twice daily local application for twelve weeks or appearance for vellous hair whichever comes earlier |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Presence of five or fewer patches of alopecia areata, involving less than 40% scalp area
2. Stable disease without the appearance of a new patch or increase in the size of the existing patch
for at least 15 days |
|
| ExclusionCriteria |
| Details |
1. Presence of atypical patterns of alopecia areata eg: ophiasis
2. Patients who have received topical or oral treatment for alopecia areata in the past 1 month
3. Patients with any other coexisting hair disorder diagnosed based on clinical history and
examination (viz., trichotillomania androgenetic alopecia, telogen effluvium)
4. Presence of any contraindication for topical corticosteroids (local skin infections, skin atrophy)
or methotrexate;
5. Pregnant and lactating women
6. Unwilling to provide informed consent
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare and study the efficacy of topical methotrexate 1% gel & topical betamethasone diproprionate 0.05% lotion in the treatment of alopecia areata |
number, size, site and shape of alopecia areata patch compared every 3 weeks at week 0, week 3, week 6, week 12 or until regrowth of short velours hair noticed on dermoscopy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the safety & tolerability of topical methotrexate 1% gel in the treatment of alopecia areata |
Evaluation of adverse effect if present & tolerability noted at week 3, week 6, week 12
|
| To evaluate the safety & tolerability of topical betamethasone diproprionate 0.05% lotion in the treatment of alopecia areata |
Evaluation of adverse effect if present & tolerability noted at week 3, week 6, week 12
|
|
|
Target Sample Size
|
Total Sample Size="88"
Sample Size from India="88"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
31/10/2023 |
| 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 will be a prospective, study conducted at Skin & VD outpatient department, Mahatma Gandhi Medical College & Hospital, Jaipur After taking written informed consent, detailed history taking and examination (including general physical examination and cutaneous examination), clinical photograph would be done. All patients will be randomized and divided into 2 groups: Group A will receive topical MTX 1% gel twice daily until complete improvement or a maximum period of 12 weeks Group B received topical steroid twice daily until complete improvement or a maximum period of 12 weeks Follow up of patients will be done at week 3, week 6, week 8 and week 12 Disease severity will be assessed at baseline and at the end of treatment using standardized scales Adverse events and laboratory parameters will be monitored throughout the study
|