| CTRI Number |
CTRI/2024/08/072542 [Registered on: 16/08/2024] Trial Registered Prospectively |
| Last Modified On: |
14/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of the effectiveness of Intralesional Methotrexate with Intralesional Triamcinolone Acetonide in the treatment of Localized patchy hair loss of the scalp. |
|
Scientific Title of Study
|
Comparison of the effectiveness of Intralesional Methotrexate with Intralesional Triamcinolone Acetonide in the treatment of Localized Alopecia Areata of the scalp - A Randomized controlled Trial.
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
KARTHIYAINI A |
| Designation |
PG student in MD DVL |
| Affiliation |
Aarupadai Veedu medical college and hospital,Pondicherry |
| Address |
Department of dermatology Aarupadai Veedu Medical college and Hospital,
Kirumampakkam,
Pondicherry
Pondicherry
PONDICHERRY
607402
India |
| Phone |
8110883943 |
| Fax |
|
| Email |
yainijessie1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sheela Kuruvila |
| Designation |
Professor and HOD in MD DVL |
| Affiliation |
Aarupadai Veedu medical college and hospital,Pondicherry |
| Address |
Department of Dermatology,
Aarupadai Veedu Medical college and Hospital,
Kirumampakkam,
Pondicherry
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9047038527 |
| Fax |
|
| Email |
sheela.kuruvila@avmc.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
KARTHIYAINI A |
| Designation |
PG student in MD DVL |
| Affiliation |
Aarupadai Veedu medical college and hospital,Pondicherry |
| Address |
Department of Dermatology,
Aarupadai Veedu Medical college and Hospital,
Kirumampakkam,
Pondicherry
Pondicherry
PONDICHERRY
607402
India |
| Phone |
8110883943 |
| Fax |
|
| Email |
yainijessie1997@gmail.com |
|
|
Source of Monetary or Material Support
|
| Aarupadai veedu medical college and hospital |
|
|
Primary Sponsor
|
| Name |
Karthiyaini A |
| Address |
Department of Dermatology,
Aarupadai veedu medical college and hospital,
Kirumampakkam,
Pondicherry
607402
|
| 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 Karthiyaini A |
AARUPADAI VEEDU MEDICAL COLLEGE AND HOSPITAL |
A block division
Room no:21
Department of Dermatology
Pondicherry
PONDICHERRY |
8110883943
yainijessie1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AVMC INSTITUTIONAL HUMAN ETHICAL COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: L63||Alopecia areata, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intralesional Methotrexate |
I/L Methotrexate (25mg/ml )
(Max.dose-5mg)
sessions will be repeated every 3 weeks for maximum three sessions and patients will be assessed on each follow-up and finally at 9th week and 12th week
Total duration - 3 months |
| Comparator Agent |
Intralesional Triamcinolone Acetonide |
I/L Triamcinolone Acetonide (10mg/ml) (Max.dose-10mg)
Sessions will be repeated every 3 weeks for maximum three sessions and patients will be assessed on each follow-up and finally at 9th week and 12th week.
Total duration- 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Adult patients with Localized Alopecia Areata of the scalp with ≤ 3 patches
2.Patients who did not receive any specific treatment for Alopecia Areata or regrowth of hair during the last 3 months.
|
|
| ExclusionCriteria |
| Details |
1.Pregnant and lactating women
2.Chronic hepatic or hematological disorders
3.Patients on systemic corticosteroids or other Immunosuppressants
4.Local infections
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To Compare the effectiveness of Intralesional Methotrexate and Intralesional Triamcinolone Acetonide in the treatment of localized Alopecia areata of the scalp clinically using SALT score and Regrowth scale.
|
Sessions will be repeated every 3 weeks for maximum three sessions(0,3,6weeks) and patient will be evaluated at 9th week and12th week.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the Trichoscopic changes following treatment of localized alopecia areata of scalp with Intralesional Methotrexate & Intralesional Triamcinolone Acetonide. |
Sessions will be repeated every 3 weeks for maximum three sessions(0,3,6weeks) & patient will be evaluated at 9th week and12th week.
|
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 1 |
|
Date of First Enrollment (India)
|
26/08/2024 |
| 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="0"
Months="3"
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
|
Alopecia areata (AA) is an autoimmune disorder characterized by clearly defined areas of non-scarring hair loss. Various therapeutic modalities are present such as corticosteroids, phototherapy, anthralin, topical minoxidil, immunotherapy with varying response.Intralesional( I/L) Triamcinolone Acetonide (TrA) is regarded as the preferred treatment for Localized AA in adults involving less than 50% of the scalp, although it has numerous adverse effects. Systemic MTX has been successfully used to treat AA, although it comes with a number of adverse effects and requires periodic laboratory monitoring.So, our aim is to evaluate the efficacy of intralesional MTX as a therapeutic option compared to Triamcinolone acetonide |