| CTRI Number |
CTRI/2021/03/031963 [Registered on: 15/03/2021] Trial Registered Prospectively |
| Last Modified On: |
13/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Microneedling with topical autologous Platelet rich plasma versus intralesional Triamcinolone acetonide in Alopecia Areata |
|
Scientific Title of Study
|
Comparative evaluation of efficacy and safety of combination of microneedling with topical autologous Platelet rich plasma versus Triamcinolone acetonide in Alopecia Areata |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Surabhi Dayal |
| Designation |
Senior Professor. and Head |
| Affiliation |
Pt B.D. Sharma, PGIMS, Rohtak |
| Address |
Deptt. of Dermatology,
Venereology and Leprology
Pt B.D. Sharma, PGIMS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9896205319 |
| Fax |
|
| Email |
surabhidayal7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Surabhi Dayal |
| Designation |
Senior Professor. and Head |
| Affiliation |
Pt B.D. Sharma, PGIMS, Rohtak |
| Address |
Deptt. of Dermatology,
Venereology and Leprology
Pt B.D. Sharma, PGIMS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9896205319 |
| Fax |
|
| Email |
surabhidayal7@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mani Mehra |
| Designation |
PG Resident |
| Affiliation |
Pt B.D. Sharma, PGIMS, Rohtak |
| Address |
Skin OPD,Room no. 238
Deptt. of Dermatology,
Venereology and Leprology
Pt B.D. Sharma, PGIMS, Rohtak
Deptt. of Dermatology,
Venereology and Leprology
Pt B.D. Sharma, PGIMS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
|
| Fax |
|
| Email |
manimehra321@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pt B.D. Sharma, Post Graduate Institute of Medical Sciences, Rohtak |
|
|
Primary Sponsor
|
| Name |
Dr Surabhi Dayal |
| Address |
Senior Professor. and Head,
Deptt. of Dermatology
Pt B.D. Sharma, PGIMS, Rohtak
|
| 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 Surabhi Dayal |
Pt B.D. Sharma, PGIMS, Rohtak |
Skin OPD, Room no.238
Deptt. of Dermatology, Venereology and Leprology
Rohtak
HARYANA |
9896205319
surabhidayal7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee,Pt B.D. Sharma, PGIMS, Rohtak |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L638||Other alopecia areata, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Combination of Microneedling With Topical Autologous Platelet Rich Plasma |
Patients in this group will be treated by microneedling technique using dermaroller in combination with topical autologous platelet rich plasma at every 4 weeks interval for a total period of 16 weeks. |
| Comparator Agent |
Intralesional Triamcinolone acetonide |
Patients in this group will be treated with intralesional Injection of Triamcinolone acetonide 10 mg/ml at every 4 weeks interval for a period of 16 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Clinically diagnosed as Alopecia Areata of the scalp less than or equal to 5 patches and less than or equal to 25 % scalp involvement and who have not taken any treatment for hair loss in the past 3 months and are willing to consent for enrollment in the study |
|
| ExclusionCriteria |
| Details |
Patients with history of bleeding disorders,on anticoagulant medications,with an active infection at local site,having keloidal tendency, having psoriasis or lichen planus because of risk of Koebner phenomenon or any other dermatological disease,having alopecia totalis or alopecia universalis,who had taken any treatment for hair-loss in the past 3 months,with history of hypersensitivity to formulation used in the study,Severe systemic illness or malignancy,Pregnant and lactating mothers. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease in the mean SALT (Severity of Alopecia Areata Tool)scores from the baseline will be compared between the two groups. |
Baseline,4 weeks,8 weeks,12 weeks and 16 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
VISUAL ANALOGUE SCALE: Patients
to grade their improvement from 0 to 10 on a 10 point scale as per his/her satisfaction.
7-10: Excellent response.
4-6: Good response.
0-3: Poor response.
|
At the end of 16 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 4 |
|
Date of First Enrollment (India)
|
15/03/2021 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
40 patients of clinically diagnosed Alopecia Areata of the scalp less than or equal to 5 patches and less than or equal to 25 % scalp involvement and who have not taken any treatment for hair loss in the past 3 months and are willing to consent for enrollment in the study will be randomly divided into 2 groups of 20 each using a computer generated randomization chart.Group -1 (COMBINATION OF MICRONEEDLING WITH TOPICAL AUTOLOGOUS PLATELET RICH PLASMA GROUP): Patients in this group will be treated by microneedling technique using dermaroller in combination with topical autologous platelet rich plasma at every 4 weeks interval for a total period of 16 weeks. Group- 2 (INTRALESIONAL TRIAMCINOLONE ACETONIDE GROUP): Patients in this group will be treated with intralesional Injection of Triamcinolone acetonide 10 mg/ml at every 4 weeks interval for a period of 16 weeks. Results of both the treatments of group 1 and group 2 will be compared at the end of therapy on the basis of reduction in the mean SALT scores from the baseline and Visual Analogue Scale. |