| CTRI Number |
CTRI/2024/04/065133 [Registered on: 03/04/2024] Trial Registered Prospectively |
| Last Modified On: |
27/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
PMS |
|
Type of Study
|
Other (Specify) [Microneedling and Microneedling with PRP] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of
microneedling vs
microneedling with platelet rich
plasma in the treatment of male-pattern hairloss |
|
Scientific Title of Study
|
Comparative study for the efficacy of
microneedling alone and
microneedling with platelet rich
plasma in male-pattern hairloss |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Divya Aneela K |
| Designation |
Junior Resident |
| Affiliation |
Government Medical College and Hospital, Chandigarh |
| Address |
Department of Dermatology, Venereology and Leprosy
Government Medical College, Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9495791878 |
| Fax |
|
| Email |
divyaaneela@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jasleen Kaur |
| Designation |
Associate Professor |
| Affiliation |
Government Medical College and Hospital, Chandigarh |
| Address |
Department of Dermatology, Venereology and Leprosy
Government Medical College and Hospital, Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646481249 |
| Fax |
|
| Email |
jasleenksandhu21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jasleen Kaur |
| Designation |
Associate Professor |
| Affiliation |
Government Medical College and Hospital, Chandigarh |
| Address |
Department of Dermatology, Venereology and Leprosy
Government Medical College and Hospital, Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646481249 |
| Fax |
|
| Email |
jasleenksandhu21@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College and Hospital, Chandigarh |
|
|
Primary Sponsor
|
| Name |
Government Medical College and Hospital, Chandigarh |
| Address |
Government Medical College and Hospital, Sector 32B, Chandigarh |
| Type of Sponsor |
Government medical college |
|
|
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 Divya Aneela K |
Government Medical College and Hospital, Chandigarh |
Department of Dermatology Venereology and Leprosy
Government Medical College and Hospital, Chandigarh
Sector 32
Chandigarh
CHANDIGARH |
9495791878
divyaaneela@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, GMCH Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L649||Androgenic alopecia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Microneedling |
Patients in this group will receive three
sessions of microneedling at 0, 4 and 8 weeks |
| Intervention |
Microneedling with PRP |
Patients in this group will receive three
sessions of microneedling with PRP application at 0, 4 and 8 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Male |
| Details |
1. Males above the age of 18 years diagnosed with AGA Hamilton grade 3, 4, 5
2. New cases of male pattern hair loss
3. Previously treated cases not under any treatment for past 6 months
|
|
| ExclusionCriteria |
| Details |
1. Malignancy or chemotherapy
2. Hematological or autoimmune disorder
3. Thrombocyte dysfunction, bleeding disorders or on anticoagulant therapy
4. Scalp area to be treated having any infection or dermatitis
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the improvement in hair growth |
The three primary efficacy measures will be the change in total and
terminal hair count, scoring of the global photographs by evaluators and patient self assessment,
assessed in both the groups at baseline and at 4 weekly intervals at 4, 8 and 12 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Adverse Effects of Treatment |
At each follow up visits- 4, 8 & 12 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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
15/04/2024 |
| 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 Yet Recruiting |
| 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
|
A randomized comparative study is being conducted to evaluate the efficacy of microneedling alone vs microneedling with platelet rich plasma in the treatment of male pattern hairloss. Males above the age of 18 years diagnosed with AGA Hamilton grade 3, 4, 5 will be recruited and and randomly alllocated into two groups of 20 each. Only microneedling group will receive three sessions of microneedling at 0, 4 and 8 weeks. Microneedling with PRP group will receive three sessions of microneedling with PRP application at 0, 4 and 8 weeks. The efficacy and safety outcome measures will be the change in total and terminal hair count, scoring of the global photographs by evaluators, patient self assesment and adverse events, assessed in both the groups at baseline and at 4 weekly intervals at 4, 8 and 12 weeks. |