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CTRI Number  CTRI/2020/06/025969 [Registered on: 18/06/2020] Trial Registered Prospectively
Last Modified On: 21/10/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   STUDY TO COMPARE TOPICAL MINOXIDIL ALONE, AND TOPICAL MINOXIDIL - PLATELET RICH PLASMA THERAPY COMBINATION IN WOMEN WITH FEMALE PATTERN HAIR LOSS. 
Scientific Title of Study   EFFICACY OF TOPICAL MINOXIDIL ALONE AND TOPICAL MINOXIDIL- PLATELET RICH PLASMA COMBINATION IN WOMEN WITH FEMALE PATTERN HAIR LOSS  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Akanksha Agarwal  
Designation  Postgraduate  
Affiliation  LADY HARDINGE MEDICAL COLLEGE 
Address  LADY HARDINGE MEDICAL COLLEGE, DEPARTMENT OF DERMATOLOGY, SHAHEED BHAGAT SINGH MARG, NEW DELHI 110001

New Delhi
DELHI
110001
India 
Phone  8447933946  
Fax    
Email  akanksha20494@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vibhu Mendiratta 
Designation  Director Professor 
Affiliation  LADY HARDINGE MEDICAL COLLEGE  
Address  LADY HARDINGE MEDICAL COLLEGE, DEPARTMENT OF DERMATOLOGY, SHAHEED BHAGAT SINGH MARG, NEW DELHI 110001

New Delhi
DELHI
110001
India 
Phone  9871016304  
Fax    
Email  vibhumendiratta@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vibhu Mendiratta 
Designation  Director Professor 
Affiliation  LADY HARDINGE MEDICAL COLLEGE  
Address  LADY HARDINGE MEDICAL COLLEGE, DEPARTMENT OF DERMATOLOGY, SHAHEED BHAGAT SINGH MARG, NEW DELHI 110001

North East
DELHI
110001
India 
Phone  9871016304  
Fax    
Email  vibhumendiratta@rediffmail.com  
 
Source of Monetary or Material Support  
LADY HARDINGE MEDICAL COLLEGE, DEPARTMENT OF DERMATOLOGY, SHAHEED BHAGAT SINGH MARG NEW DELHI 110001 
 
Primary Sponsor  
Name  LADY HARDINGE MEDICAL COLLEGE 
Address  LADY HARDINGE MEDICAL COLLEGE, DEPARTMENT OF DERMATOLOGY SHAHEED BHAGAT SINGH MARG NEW DELHI 110001 
Type of Sponsor  Government 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 
Akanksha Agarwal   LADY HARDINGE MEDICAL COLLEGE   LADY HARDINGE MEDICAL COLLEGE, DEPARTMENT OF DERMATOLOGY, SHAHEED BHAGAT SINGH MARG, NEW DELHI 110001
New Delhi
DELHI 		 8447933946

akanksha20494@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE LADY HARDINGE MEDICAL COLLEGE AND ASSOCIATED HOSPITALS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L659||Nonscarring hair loss, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  2% minoxidil   Topical 2% minoxidil to be applied daily twice for six months 
Intervention  Platelet rich plasma therapy and 2% minoxidil combination   Plasma is first extracted from the venous blood from which the platelets are then concentrated by the method of centrifugation. These are then injected in to the patients scalp periodically. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Female 
Details  1. Females aged 18-55 years with a clinical and trichoscopic diagnosis of FPHL.
2. Ludwig score 1-3, all patterns of FPHL.
3. Females giving consent for photography of the scalp. 
 
ExclusionCriteria 
Details  1. Pregnant and lactating females.
2. Known case of polycystic ovarian disorder (PCOD) or presence of clinical signs suggestive of PCOD.
3. H/o oopherectomy, autoimmune or endocrinological disorder (Cushings/Addisons disease), platelet disorders, bleeding disorders, malignancy or keloidal tendency.
4. History of any treatment for hair loss in the past 90 days (oral/topical hair growth boosters/hormonal therapy/anticancer drugs or steroids).
5. Any active scalp infection.
6. Pregnant Patients with positive viral markers (HIV 1 and 2, Hepatitis B & C) or otherwise immunocompromised . 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Comparative assessment of the proportion of patients with patient satisfaction score more than 6  at 24 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
❖ Comparative assessment of the following parameters in the two groups.
1. Mean change in hair density from baseline to 6 months
2. Proportion of patients showing improved hair density on global photography.
3. Proportion of patients showing negative hair pull test at the end of 6 months.
4. Percentage of patients showing side effects of PRP therapy.

 		 Day 0, 4th, 8th, 12th, 20th and 24th week. 
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
Final Enrollment numbers achieved (Total)= "26"
Final Enrollment numbers achieved (India)="26" 
Phase of Trial   N/A 
Date of First Enrollment (India)   21/06/2020 
Date of Study Completion (India) 01/10/2021 
Date of First Enrollment (Global)  21/06/2020 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Results will be published in a scientific journal 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   Female pattern hair loss (FPHL) refers to a progressive decline in hair fibre production by scalp hair follicles and their eventual miniaturisation. Women who seek medical advice for their hair loss experience more negative body image feelings, more social anxiety and poorer self esteem and psychosocial well being than control subjects with non visible skin disease, as well as dissatisfaction with their hair. Platelet-rich plasma (PRP) is a treatment modality that has gained popularity for FPHL over the years due to its autologous nature, minimal invasiveness, absence of major side effects, better compliance and more affordable cost compared with hair restoration surgery. PRP is an autologous preparation of platelets in concentrated plasma (usually N 1,000,000 platelets/μL or 2-7 times the native concentration of whole blood). 
This study is a randomised controlled trial to assess the efficacy of minoxidil alone and minoxidil-platelet rich plasma therapy combination in women with female pattern hair loss. The randomisation will be done using computer generated randomization sequence by person not involved in the study. Sealed opaque envelopes containing group codes will be prepared. Envelopes will be sequentially numbered and kept in order according to their serial number. Envelope will be opened at the time of randomization and the patient will be allocated to their respective group.
Autologous PRP suspension (1-3ml) will be injected intradermally (as per the dimensions of the affected area. As a standard protocol which is being followed in the department, 0.1 ml is injected at a distance of 1 cm in the affected area of FPHL in minimum of 4 (monthly) sessions.)
Patient will be instructed to apply 1ml of the minoxidil 2% solution over the affected site twice daily. 

Following observations will be made ;
1. Comparative assessment of the proportion of patients with patient satisfaction score of more than 6

Comparative assessment of the following parameters in the two groups.

1. Mean change in hair density from baseline to 6 months 
2. Proportion of patients showing improved hair density on global photography.
3. Proportion of patients showing negative hair pull test at the end of 6 months.
4. Percentage of patients showing side effects of PRP therapy.




 
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