| CTRI Number |
CTRI/2024/09/073394 [Registered on: 04/09/2024] Trial Registered Prospectively |
| Last Modified On: |
28/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Biological |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparision of autologous Growth Factor Concentrate injection versus Platelet Rich Plasma injection in patients of Androgenic Alopecia receiving topical minoxidil |
|
Scientific Title of Study
|
Efficacy of autologous Growth Factor Concentrate injection and Platelet Rich Plasma injection in patients of Androgenic Alopecia receiving topical minoxidil: A randomized control trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NA |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shini Choubey |
| Designation |
Junior resident |
| Affiliation |
Kalinga Institute of Medical Sciences |
| Address |
Department of Dermatology
Kalinga Institute of Medical Sciences, PAtia, Bhubaneshwar
Khordha
ORISSA
751024
India |
| Phone |
8108306532 |
| Fax |
|
| Email |
choubeyshini@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Laxman Besra |
| Designation |
Junior resident |
| Affiliation |
Kalinga Institute of Medical Sciences |
| Address |
Department of Dermatology,
1st Floor, Old OBG Building
Kalinga Institute of Medical Sciences
Khordha
ORISSA
751024
India |
| Phone |
8108306532 |
| Fax |
|
| Email |
laxman.derm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shini Choubey |
| Designation |
Junior resident |
| Affiliation |
Kalinga Institute of Medical Sciences |
| Address |
Department of Dermatology,
1st floor, OBG Building
Kalinga Institute of Medical Sciences, Patia, Bhubaneshwar
Khordha
ORISSA
751024
India |
| Phone |
8108306532 |
| Fax |
|
| Email |
choubeyshini@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Shini Choubey |
| Address |
Department of Dermatology, 1st floor, Old OBG Building , Kalinga Institute of Medical Sciences, Bhubaneshwar, Odisha, India - 751024 |
| Type of Sponsor |
Private 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 |
| Shini Choubey |
Kalinga Institute of Medical Sciences |
KIIT road, Patia, Bhubaneshwar
Khordha
ORISSA |
8108306532
choubeyshini@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L00-L99||Diseases of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
GROWTH FACTOR CONCENTRATE INJECTIONS |
AUTOLOGOUS GROWTH FACTOR CONCENTRATE EXTRACTED USING CENTRIFUGATOR AND INJECTED IN THE SCALP AS INTRAEPIDERMAL INJECTIONS ONCE EVERY MONTH FOR 3 MONTHS |
| Comparator Agent |
PLATELET RICH PLASMA INJECTIONS |
AUTOLOGOUS PLATELET RICH PLASMA INJECTIONS USING CENTRIFUGATOR AND INJECTED IN THE SCALP AS INTRAEPIDERMAL INJECTIONS ONCE EVERY MONTH FOR 3 MONTHS |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. AGA patient: Hamilton and Norwood classification grade: II– IV in male and Ludwig classification grade – I and II female
2. Both male and female between 21-45 years of age.
3. Androgenic Alopecia patients who have not received any other systemic or topical treatment.
|
|
| ExclusionCriteria |
| Details |
Exclusion criteria:
1. Pregnant or lactating females
2. Patients with history of any existing scalp skin diseases (seborrheic dermatitis and scalp psoriasis), infections
3. Severe systemic illness (as uncontrolled DM or hypertension, liver or renal diseases)
4. Immunocompromised patients
5. Alopecia caused by other factors such as telogen effluvium, alopecia areata, or scarring alopecia.
6. Patients who are positive for HIV/ HBsAg /HCV/ VDRL. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy by comparing the final terminal and vellus hair ratio of both the groups. |
Baseline and 3rd month. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
PATIENT SATISFACTION SCORE
PAIN GRADATION |
END OF 3 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
22/09/2024 |
| 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 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
|
Androgenic alopecia
(AGA), is a common form of hair loss worldwide affecting both men and women,
leading to significant psychosocial impacts. Topical minoxidil and oral finasteride
are the only FDA-approved drugs for the treatment. With limited available drugs
and their reported side effects, newer treatment modalities such as Platelet
rich plasma (PRP), growth factor concentrate (GFC) and threads are being tried.
This study aims to evaluate and compare the efficacy of GFC and PRP injections
as an adjunct therapy to topical minoxidil in AGA patients. |