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CTRI Number  CTRI/2024/07/070098 [Registered on: 05/07/2024] Trial Registered Prospectively
Last Modified On: 05/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study to compare minoxidil lotion and minoxidil plus platelet rich plasma therapy in male pattern hairloss 
Scientific Title of Study   Trichoscopic comparison of 5% minoxidil lotion monotherapy versus its combination with autologous platelet rich plasma therapy in androgenetic alopecia 
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 GOPAL PRASAD PODDAR 
Designation  Junior Resident 
Affiliation  Era’s Lucknow Medical College and Hospital 
Address  Department of dermatology Era’s Lucknow Medical College and Hospital Sarfarazganj Lucknow, Uttar pradesh

Lucknow
UTTAR PRADESH
226003
India 
Phone  09634063680  
Fax    
Email  poddargopal19@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR KSHITIJ SAXENA 
Designation  Professor  
Affiliation  Era’s Lucknow Medical College and Hospital 
Address  Department of Dermatology Era ‘s Lucknow Medical College and Hospital Sarfarazganj Lucknow, Uttar pradesh

Lucknow
UTTAR PRADESH
226003
India 
Phone  9208015391  
Fax    
Email  drkshitijsaxena@live.com  
 
Details of Contact Person
Public Query
 
Name  DR GOPAL PRASAD PODDAR 
Designation  Junior Resident 
Affiliation  Era’s Lucknow Medical College and Hospital  
Address  Department of dermatology Era’s Lucknow Medical College and Hospital Sarfarazganj Lucknow, Uttar pradesh

Lucknow
UTTAR PRADESH
226003
India 
Phone  09634063680  
Fax    
Email  poddargopal19@gmail.com  
 
Source of Monetary or Material Support  
Era s lucknow medical college and hospital Sarfarazganj Lucknow, Uttar Pradesh 226003 India  
 
Primary Sponsor  
Name  ERA S LUCKNOW MEDICAL COLLEGE AND HOSPITAL 
Address  Department of dermatology Era s lucknow medical college and hospital Sarfarazganj Lucknow, Uttar pradesh, 226003  
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR GOPAL PRASAD PODDAR  Era s lucknow medical college and hospital  Department of dermatology Room No.2 Era s lucknow medical college and hospital Sarfarazganj Lucknow, Uttar Pradesh 226003
Lucknow
UTTAR PRADESH 
9634063680

poddargopal19@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Eras Lucknow Medical College and Hospital, Lucknow  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L649||Androgenic alopecia, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  5% MINOXIDIL  Minoxidil Dose-5% Frequency-Twice Daily Route- Topical application over the scalp Follow up- 3weeks, 6weeks,9weeks, 12weeks Duration of study- 12 weeks after completion of trial period, treatment of patient with the drug shall continue if necessary.  
Comparator Agent  5% MINOXIDIL AND PLATELET RICH PLASMA THERAPY  Minoxidil 5% + Platelet rich plasma therapy Dose(Minoxidil)- 5% Frequency(Minoxidil 5%)-Twice Daily Frequency(Platelet rich plasma therapy)-Thrice weekly Route (Minoxidil 5%)- Topical application over the scalp Route(Platelet rich plasma therapy)- intradermal Follow up- 3weeks, 6weeks,9weeks, 12weeks Duration of study- 12 weeks after completion of trial period, treatment of patient with the drug shall continue if necessary.  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Male 
Details  All consenting male patients in the age group of 20–50 years with AGA stage II–VI Norwood-Hamilton classification visiting in dermatology OPD. 
 
ExclusionCriteria 
Details  1.Patients who have taken any form of treatment in past three months.
2.Patient with a history of hypersensitivity to minoxidil.
3.Patient with a history of bleeding disorders, on anticoagulants medications (aspirin, warfarin, heparin) and and with positive viral markers.
4.Patients with active infection at local site, nonpatterned alopecia, keloidal tendency, history of psoriasis, lichen planus and vitiligo.
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Alternation 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
•To trichoscopically assess and compare the effectiveness of 5% minoxidil alone and its combination with platelet rich plasma therapy.  Baseline,3 Weeks,6 Weeks,9 Weeks,12 Weeks 
 
Secondary Outcome  
Outcome  TimePoints 
•To trichoscopically evaluate the response in patient with 5% minoxidil monotherapy in individuals with AGA.
•To trichoscopically evaluate the synergistic effects of the combined therapy of 5% minoxidil & PRP in individuals with AGA.
•To analyze potential side effects during the course of treatment.

 
Baseline,3 Weeks,6 Weeks,9 Weeks,12 weeks 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   16/07/2024 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

A total of 60 patients of androgenetic alopecia visiting dermatology OPD of Era’s Lucknow Medical College and Hospital fulfilling inclusion criteria will be enrolled in our study. Written and informed consent from patients will be taken prior to participation in study. Patients will be randomly divided into two groups  A and B each containing 30  individuals each. History, clinical examination with trichoscopic evaluation and photographic documentation will be done before the start of the treatment and then at each visit (baseline,3weeks,6weeks,9 weeks and 12 weeks) and results will be tabulated in respective tables. In group A- each patient will be advised minoxidil (5%) twice daily application over scalp for 3weeks with follow up at every 3 week. In group B- each patient will be advised minoxidil (5%) twice daily application over scalp for 3 weeks with platelet rich plasma therapy sessions over scalp at every 3 weeks with follow up at every 3week. Under aseptic precautions, around 16ml of peripheral blood will be collected from the median cubital vein and transferred into a sodium citrate vacutainer. The tubes will be  rotated in a centrifuge machine (REMI) at 2,000 revolutions per minute for 6 minutes and the Buffy coat along with the plasma will be collected with the help of a pipette in another test tube. This tube will again be subjected to asecond centrifugation at 4000 revolutions per minute for 10 minutes. The upper layer containing platelet poor plasma will be discarded, and the lower layer of the PRP will be collected in another clean tube. Multiple PRP injections of 0.1 ml will be given at each site in a linear pattern 1 cm apart using the nappage technique.

 
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