| CTRI Number |
CTRI/2025/05/086230 [Registered on: 02/05/2025] Trial Registered Prospectively |
| Last Modified On: |
02/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Platelet rich fibrin / platelet rich plasma] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the Effectiveness and Safety of Platelet-Rich Fibrin vs. Platelet-Rich Plasma Injections in Treating Alopecia Areata |
|
Scientific Title of Study
|
A Comparative study of efficacy and safety of intralesional platelet rich fibrin vs intralesional platelet rich plasma in patients of alopecia areata |
| 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 Deepak soan |
| Designation |
Junior resident |
| Affiliation |
Dr RPGMC Tanda |
| Address |
Department of Dermatology venreology and leprosy
OPD 7
Dr RPGMC Tanda
Kangra
Himachal pradesh
Department of DVL
OPD7
DR RPGMC Tanda
Kangra
Himachal pradesh
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
7737638288 |
| Fax |
|
| Email |
deepsoan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof KS Mehta |
| Designation |
HOD |
| Affiliation |
Department of DVL, Dr RPGMC Tanda |
| Address |
Department of DVL Dr RPGMC Tanda Kangra Himachal pradesh
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9418457647 |
| Fax |
|
| Email |
hoddermatologytanda@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepak soan |
| Designation |
Junior resident |
| Affiliation |
Dr RPGMC Tanda |
| Address |
Department of Dermatology venreology and leprosy OPD 7
Dr RPGMC Tanda
Kangra
Himachal pradesh
Department of Dermatology venreology and leprosy OPD 7
Dr RPGMC Tanda
Kangra
Himachal pradesh
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
7737638288 |
| Fax |
|
| Email |
deepsoan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of DVL Dr RPGMC tanda Kangra H.P. |
|
|
Primary Sponsor
|
| Name |
Dr RPGMC Tanda |
| Address |
Department of DVL Dr RPGMC tanda Kangra H.P. |
| 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 Deepak soan |
Dr RPGMC Tanda |
Department of DVLDr RPGMC Tanda Kangra Himachal Pradesh
Kangra
HIMACHAL PRADESH |
07737638288
deepsoan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. Rajendra Prasad Government Medical College (Dr. RPGMC) Kangra at Tanda, Himachal Pradesh, India - 176 001 Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L639||Alopecia areata, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Patients of AA will receive intralesional injections of platelet rich plasma prepared in
departmental lab |
Half patches of AA will receive Intralesional PRP.
PRP is prepared collecting venous blood approximately 6-10 mL from the patient and placing it into tubes
containing an Anticoagulant, either acid citrate dextrose or sodium citrate solution to prevent coagulation and premature secretion of the alpha granules. Subsequently, whole blood is
centrifuged and divided into 3 layers based on specific gravity, the bottom layer contains red blood cells (RBCs) with leukocytes the middle layer is the PRP, and the top layer is platelet-poor plasma
(PPP). The platelet alpha granules secrete growth factors within 10 minutes after clotting or
activation, so PRP should be used within 10 minutes of activation for maximum benefits. |
| Intervention |
Patients of AA will receive Intralesional Platelet rich fibrin |
Half of the patches of AA will receive intralesional injections of platelet rich fibrin prepared in
departmental lab.
Preparation of Platelet Rich Fibrin Total 6ml of blood will be collected and filled in vacutainers
(without an anticoagulant) of 10 ml each and will be centrifuged immediately at 1000 rotations per
minute for 6 minutes using a centrifuge machine. The I-PRF liquid will be collected using 31G
insulin syringes and will be injected using insulin syringe with 31G needle entering 2-4 mm on the
affected scalp. A total of 1 to 2 ml of liquid will be injected at a distance of 1cm apart known as
the nappage technique once in 1 month for 6 cycles (0,1,2,3,4,5 months). The fluid was injected immediately to prevent the clotting as no anti-coagulant was used. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of AA between Age group 18 to 50 years.
2. Diagnosed clinically with alopecia areata of scalp coming to skin opd.
3. Patients willing to give consent for inclusion in study
4. Patients who have not taken medical treatment for AA in any form for the last 6 months.
5. Control group includes age and sex matched individuals without history of AA
6. Platelet count more than 1.5 lac |
|
| ExclusionCriteria |
| Details |
1. Patients with alopecia other than alopecia areata.
2. Patients with active infection at the local site.
3. Patients having keloidal tendency.
4. Patients with blood coagulopathies.
5. Platelet count less than 1.5 lacs per µl.
6. Patients who are immunosuppressed (HIV, malignancy, steroid or chemotherapy).
7. Pregnancy or lactation
8. Patients not willing to give written informed consent.
9. Patient on anticoagulation. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Investigator assessment scale |
Baseline, 2, 4, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Trichoscopic Analysis
1 Size of alopecia patch using measuring tape
2 Location Of alopecia patch |
Baseline, 2, 4, 6 months |
| Patients self-assessment |
Baseline, 2, 4, 6 months |
| Improvement assessment based on SALT score |
Baseline, 2, 4, 6 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
13/05/2025 |
| 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="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
|
Alopecia Areata is a common autoimmune disease with non-scarring type of hair loss without any clinical inflammatory signs, most treatments require multiple sittings of treatment and multiple needle pricks, some of treatment can cause atrophy, recurrence rates are also high. In this study aim is to study the efficacy and safety of platelet rich fibrin in the treatment of alopecia areata and to compare efficacy and safety of intralesional platelet rich fibrin vs intralesional platelet rich plasma in patients of alopecia areata. |