| CTRI Number |
CTRI/2024/03/064873 [Registered on: 28/03/2024] Trial Registered Prospectively |
| Last Modified On: |
28/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [PLASMA RICH FIBRIN] |
| Study Design |
Other |
|
Public Title of Study
|
To compare the efficacy and safety of injectable platelet rich fibrin therapy and topical minoxidil (5%) fortified with finasteride (0.1%) in the treatment of androgenetic alopecia |
|
Scientific Title of Study
|
The efficacy and safety of injectable platelet rich fibrin (PRF) therapy and topical minoxidil (5%) fortified with finasteride (0.1%) in the treatment of androgenetic alopecia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nitika Dhiman |
| Designation |
Junior Resident |
| Affiliation |
Dr Rajendra Prasad Government Medical College Kangra at Tanda |
| Address |
Department of dermatology venerology and leprosy, dr rpgmc kangra at tanda
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9805335376 |
| Fax |
|
| Email |
rubbybeeru@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K S Mehta |
| Designation |
Professor and head |
| Affiliation |
Dr Rajendra Prasad Government Medical College Kangra at Tanda |
| Address |
Department of dermatology venerology and leprosy, dr rpgmc kangra at tanda
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9418457647 |
| Fax |
|
| Email |
drkaranindermehta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nitika Dhiman |
| Designation |
Junior Resident |
| Affiliation |
Dr Rajendra Prasad Government Medical College Kangra at Tanda |
| Address |
Department of dermatology venerology and leprosy, dr rpgmc kangra at tanda
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9805335376 |
| Fax |
|
| Email |
rubbybeeru@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Rajendra Prasad Government Medical College Kangra at Tanda |
|
|
Primary Sponsor
|
| Name |
Dr Rajendra Prasad Medical College Kangar at Tanda |
| Address |
DR Rajendra Prasad Medical College Kangra at Tanda |
| 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 |
| Nitika Dhiman |
Dr Rajendra Prasad Government Medical College Kangra at Tanda |
Opd -8 , Department of dermatology venerology and leprosy
Kangra
HIMACHAL PRADESH |
9805335376
rubbybeeru@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DR RPGMC KANGRA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L648||Other androgenic alopecia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Plasma rich fibrin |
Plasma rich fibrin obtained from patient blood and injected in the scalp of the patient and then results will evaluated
time duration 1 year |
| Comparator Agent |
Topical minoxidil 5% fortified with finasteride 0.1% |
Applied on scalp
time duration 1 year |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Male |
| Details |
Age group 18-50 years
Presenting with patterned hair loss
Males - norwood hamilton grade 3,4,5
Patients who have not taken medical treatment for aga in any form for the last 6 months
|
|
| ExclusionCriteria |
| Details |
Patients with alopecia other than androgenetic alopecia
Patient with active infection at the local site
Patient have keloidal tendency
Patient with blood coagulopathies
Platelet count less than 1.5 lac/ul
Patients who are immunocompromised(hiv, malignancy, steroid or chemotherapy)
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Efficacy and safety of injectable platelet rich fibrin therapy and topical minoxidil(5%) fortified with finasteride(0.1%) in the treatment of androgenetic alopecia |
52 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| reported adverse events of the procedure in both intervention & comparator agent |
52 weeks |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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 2 |
|
Date of First Enrollment (India)
|
07/04/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
07/03/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [rubbybeeru@gmail.com].
- For how long will this data be available start date provided 20-06-2023 and end date provided 30-07-2025?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
Androgenetic Alopecia is a nonscarring alopecia
that affects both men and women. The onset of Androgenetic Alopecia
is usually gradual and the condition slowly develops over the years. It is characterized by a progressive
miniaturization of hair follicles with a characteristic pattern distribution in
genetically predisposed men and women. Is the most frequent type of hair loss
in both sexes. Although
Androgenetic Alopecia is more frequent in adults, it can also appear in
adolescents , though its prevalence among this younger population is not well
established. Treatments include
pharmacotherapy, surgery, and cosmetic aids. Despite the demand, there are only
two FDA-approved medications to treat Androgenetic Alopecia: the potassium
channel opener Minoxidil, and the DHT synthesis inhibitor Finasteride, both
effective at controlling AGA with long-term daily use. However, they are
costly, require lifelong treatment and may have side effects. Medical therapy
is most effective when started in the early phases of hair loss and patients
may elect to be treated non-surgically only. Undoubtedly, medical therapy will
play a central role as an adjunct to surgical treatment by preventing the loss
of surrounding native hair and thus enhancing the overall esthetic result. PRF is actually a new
platelet concentrate concept which accumulates platelets and the released
cytokines in a fibrin clot. Advanced-PRF (A-PRF) and Injectable-PRF (i-PRF), on
the other hand, are different from conventional PRF and is based on the concept
that low speed of centrifugation, yields maximum results and significantly
higher number of leukocytes, platelets, and growth factor
concentration-enhancing the regeneration process. This study aims to compare the efficacy and safety of intradermal platelet rich plasma (PRF) therapy and topical minoxidil (5%) fortified with finasteride (0.1%) in the treatment of androgenetic alopecia.
|