| CTRI Number |
CTRI/2025/06/089408 [Registered on: 24/06/2025] Trial Registered Prospectively |
| Last Modified On: |
23/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [growth factors] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of efficacy between two modalities of treatment in diffuse hairloss. |
|
Scientific Title of Study
|
Efficacy of autologous platelet rich plasma(PRP) versus growth factor concentrate(GFC) in moderate androgenetic alopecia: a randomized open-label trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Yogindher singh |
| Designation |
Assistant Professor |
| Affiliation |
Sri Venkateshwaraa medical college hospital |
| Address |
Sri Venkateshwaraa medical college hospital ariyur Puducherry
Department of D.V.L
Room no. - 110
Pondicherry
PONDICHERRY
605102
India |
| Phone |
06382353526 |
| Fax |
|
| Email |
yogindher4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yogindher singh |
| Designation |
Assistant Professor |
| Affiliation |
Sri Venkateshwaraa medical college hospital |
| Address |
Sri Venkateshwaraa medical college hospital ariyur Puducherry
Department of D.V.L
Room no. - 110
Pondicherry
PONDICHERRY
605102
India |
| Phone |
06382353526 |
| Fax |
|
| Email |
yogindher4@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yogindher singh |
| Designation |
Assistant Professor |
| Affiliation |
Sri Venkateshwaraa medical college hospital |
| Address |
Sri Venkateshwaraa medical college hospital ariyur Puducherry
Department of D.V.L
Room no. - 110
Pondicherry
PONDICHERRY
605102
India |
| Phone |
06382353526 |
| Fax |
|
| Email |
yogindher4@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Venkateshwaraa medical college hospital, Ariyur, Puducherry- 605 102, INDIA |
|
|
Primary Sponsor
|
| Name |
Dr Yogindher Singh |
| Address |
Sri Venkateshwaraa medical college hospital Ariyur Puducherry- 605 102, INDIA |
| Type of Sponsor |
Other [self-funded] |
|
|
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 Yogindher singh |
Sri venkateshwaraa medical college hospital |
Sri Venkateshwaraa medical college hospital ariyur Puducherry- 605 102
Department of D.V.L
Room no.- 110
Pondicherry
PONDICHERRY |
06382353526
yogindher4@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Venkateshwaraa Medical College (Institutional Ethics Committee) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L649||Androgenic alopecia, unspecified, (2) ICD-10 Condition: L649||Androgenic alopecia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Growth factor concentrate (GFC) |
GFC Two GFC gel tube will be taken
8ml of patient’s whole blood will be infused into each tube, inverted for 6-10 times and kept for 30 minutes.
Then both tubes will be centrifuged at 3600 rpm for 10 minutes.
Separated plasma will be loaded in insulin syringe (5ml) and injected over low density area of scalp (pre-anesthetized).
Minoxidil 5% OD application will be followed for both groups.
Total 4 sessions. (4 months) |
| Intervention |
platelet rich plasma (PRP) |
PRP and GFC will be done every month (minimum of 4 sessions)
PRP Two PRP tubes with anticoagulant citrate dextrose (ACD) will be taken.
7ml of patients whole blood will be infused into each tube.
Then both the tubes will be centrifuged at 1800 rpm for 10 mins.
Following which the separated plasma will be withdrawn and collected in red vacutainer and subjected to second spin with 3600 rpm for 15 mins.
Now the centrifuged platelet rich plasma will be loaded in insulin syringe and injected (5ml) over pre-anesthetized scalp (low density areas).
Topical anesthetic cream (5% lidocaine and prilocaine) is applied to the areas to be treated 45 minutes before the injection.
Total of 4 sessions. (4 month)
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with androgenetic alopecia (Hamilton-Norwood grade 2-4; Ludwigs scale grade 1 and 2)
|
|
| ExclusionCriteria |
| Details |
Patients age less than 18 years.
Patients with infective and inflammatory scalp dermatoses.
Patients with scarring alopecia.
Patients with blood diathesis.
Patients on treatment for AGA in last 3 months.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcomes Global photographic assessment of improvement at the vertex and frontal view. Graded 1 to 7 as dense, moderate, minimal regrowth and dense, moderate, minimal, no loss. First three grades were considered as responders and latter four as non responders.
From baseline to 16 weeks terminal hair count, total hair density, proportion of anagen hairs will be assessed and documented.
|
Primary outcomes Global photographic assessment of improvement at the vertex and frontal view. Graded 1 to 7 as dense, moderate, minimal regrowth and dense, moderate, minimal, no loss. First three grades were considered as responders and latter four as non responders.
From baseline to 16 weeks terminal hair count, total hair density, proportion of anagen hairs will be assessed and documented.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary outcomes as subject satisfaction with hair fall, hair density & texture on a scale of 1-10 .
|
every 3rd 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
|
N/A |
|
Date of First Enrollment (India)
|
04/07/2025 |
| 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
|
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [yogindher4@gmail.com].
- For how long will this data be available start date provided 10-08-2025 and end date provided 10-08-2030?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Androgenetic alopecia (AGA) is the most often encountered chronic non-scarring form of hair loss. It
affects both men and women. It is androgen dependent and characterised by
progressive thinning of hair, reduced density, and recession of hair line. Hair
is considered an important
component of self-image. Hair loss affects the self-esteem of an individual
and can lead to impaired quality of life. There are various treatment options
available for AGA. Platelet rich plasma (PRP) is a centrifuged analogous
concentration of platelets which have growth factors which have significant effect
on hair growth. Growth factor concentrate (GFC)
therapy is modified PRP technique which have gained
attention in the treatment of AGA in recent times. To our knowledge there is a
paucity of studies comparing the outcomes of PRP and GFC for treatment of AGA. Hence,
we aim to compare the efficacy of both in Indian patients.
|