| CTRI Number |
CTRI/2023/08/056519 [Registered on: 16/08/2023] Trial Registered Prospectively |
| Last Modified On: |
15/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy And Safety Of injectable PRF As An Adjuvant with topical minoxidil In Treatment Of Male Patterned Baldness |
|
Scientific Title of Study
|
Efficacy And Safety Of iPRF(Injectable Platelet Rich Fibrin) As An Adjuvant In Treatment Of Male Patterned Baldness |
| 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 Balkrishna Nikam |
| Designation |
Associate Professor |
| Affiliation |
Krishna institute of medical sciences |
| Address |
Nital Skin Clinic
Sheetal Chambers, Opp Cottage Hospital, Budhwar Peth, Station Road, Karad, Dist Satara
pune bangalore highway, malkapur, karad
Satara
MAHARASHTRA
415110
India |
| Phone |
8275061393 |
| Fax |
|
| Email |
mangeshnikam@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohan Kale |
| Designation |
Head of Department |
| Affiliation |
Krishna institute of medical sciences |
| Address |
krishna institute of medical sciences karad malkapur
Satara
MAHARASHTRA
415110
India |
| Phone |
9823087223 |
| Fax |
|
| Email |
docmsk2@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Balkrishna Nikam |
| Designation |
Associate Professor |
| Affiliation |
Krishna institute of medical sciences |
| Address |
Nital Skin Clinic
Sheetal Chambers, Opp Cottage Hospital, Budhwar Peth, Station Road, Karad, Dist Satara
pune bangalore highway, malkapur, karad
Satara
MAHARASHTRA
415110
India |
| Phone |
8275061393 |
| Fax |
|
| Email |
mangeshnikam@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Krishna Institute of Medical Sciences, Karad Maharashtra 415110 |
|
|
Primary Sponsor
|
| Name |
Krishna Institute of Medical Sciences |
| Address |
Pune bangalore highway,malkapur, karad, dist Satara |
| 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 |
| Navya Pandey |
Krishna Hospital, Krishna Institute of Medical Sciences Karad |
department of dermatology opd 29
Malkapur, Karad
Satara
MAHARASHTRA |
9140195966
navya24pan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| krishna institute of medical sciences instituitional ethics committee |
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 |
| Intervention |
injectable platelet rich fibrin |
iPRF will be prepared by centrifugation and injected over scalp using insulin syringes
procedure will be repeated monthly for 6 months |
| Comparator Agent |
Platelet rich Plasma |
Centrifuged PRP will be injected over scalp using insulin syringes. Inj lignocaine will be given locally beforehand
procedure will be repeated monthly for six months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Male |
| Details |
1. Have given written consent before any treatment is commenced.
2. Be diagnosed to be suffering from male patterned baldness by assessment through Hamilton and Norwood Scale(Grade 2 to 6) clinically in DERMATOLOGY OPD
3. Have completed 18 years of age. |
|
| ExclusionCriteria |
| Details |
A. Patient having keloid scarring or keloidal tendency.
B. History of bleeding disorder and anticoagulant therapy.
C. Active skin infection over scalp.
D. Patient on any other systemic drugs therapy which in the judgement of investigator may interfere with interpretation of results.
E. Patients with known hypersensitivity to topical anaesthetic agents. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in hairloss |
Reduction in hairloss in 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| identification of better adjuvant |
new hair growth in 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
|
N/A |
|
Date of First Enrollment (India)
|
26/08/2023 |
| 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
|
none |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a randomized comparative study between PRP and iPRF treatments when given as an adjuvant along with topical minoxidil for androgenic alopecia in males. Through this study we will be comparing the efficacy and safety of both the adjuvant treatments and finding out the better one for the treatment of androgenic alopecia. |