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CTRI Number  CTRI/2025/06/088077 [Registered on: 02/06/2025] Trial Registered Prospectively
Last Modified On: 30/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Preventive 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparing Minoxidil vs a Redensyl- based formula, Both combined with PRP therapy, for treating Male pattern baldness in men (18-55years) at a Kelambakkam hospital. 
Scientific Title of Study   A COMPARATIVE STUDY OF TOPICAL 5 PERCENT MINOXIDIL WITH PLATELET RICH PLASMA THERAPY VERSUS TOPICAL REDENSYL, CAPIXYL AND PROCAPIL COMBINATION WITH PLATELET RICH PLASMA THERAPY IN THE TREATMENT OF ANDROGENETIC ALOPECIA IN MEN AGED 18-55 YEARS AT A TERTIARY HEALTH CARE CENTRE IN KELAMBAKKAM 
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 J Mirudula Josena 
Designation  Post graduate resident 
Affiliation  Chettinad Hospital and Research Institute, Chettinad Academy of Research and Education 
Address  Department of Dermatology, Venereology and Leprosy. OP no:18
Chettinad Hospital and Research Institute, Chettinad Health City, Rajiv Gandhi Salai (OMR), Kelambakkam, Tamilnadu
Chennai
TAMIL NADU
603103
India 
Phone  044-47428101  
Fax    
Email  mirudulajosena18@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Gopalakrishnan K 
Designation  Professor and HOD 
Affiliation  Chettinad Hospital and Research Institute, Chettinad Academy of Research and Education 
Address  Department of Dermatology, Venereology and Leprosy. OP no:18
Chettinad Hospital and Research Institute, Chettinad Health City, Rajiv Gandhi Salai, (OMR, Chennai), Kelambakkam
Chennai
TAMIL NADU
603103
India 
Phone  044-47428101  
Fax    
Email  gopukris83@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Gopalakrishnan K 
Designation  Professor and HOD 
Affiliation  Chettinad Hospital and Research Institute, Chettinad Academy of Research and Education 
Address  Department of Dermatology, Venereology and Leprosy. OP no:18
Chettinad Hospital and Research Institute, Chettinad Health City, Rajiv Gandhi Salai, (OMR, Chennai), Kelambakkam
Chennai
TAMIL NADU
603103
India 
Phone  044-47428101  
Fax    
Email  gopukris83@gmail.com  
 
Source of Monetary or Material Support  
Chettinad Hospital and Research Institute 
 
Primary Sponsor  
Name  Dr J Mirudula Josena  
Address  Gardenia, Plot 7s, 94/1ab Blue Beach, Neelankarai, Chennai-600115 
Type of Sponsor  Other [Self] 
 
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 J Mirudula Josena  Chettinad Hospital and Research Institute, Chettinad Academy of Research and Education  Department of Dermatology, Venereology and Leprosy, OP no: 18, Chettinad Health City, Rajiv Gandhi Salai, (OMR, Chennai), Kelambakkam, Tamil Nadu-603 103 India.
Chennai
TAMIL NADU 
044 47428101

hod.dermatology@care.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Chettinad Academy of Research and Education, Institutional Human Ethics Committee for Student Research (CARE IHEC-I)  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 
Comparator Agent  Topical 5 percent Minoxidil with platelet rich plasma  Patients will receive PRP therapy once every 4 weeks (total-6 sessions) with topical medications every-day. PRP will be prepared by collecting 9ml of fresh blood in sodium citrate-containing bottles under aseptic precaution. The protocol of soft spin (2000revolution/minute for 6 minutes) and hard spin (4000revolutions/minute for 10minutes) is done. After collecting concentrated plasma, 1cc syringes are used to inject it intradermally. Patients will be instructed to use Topical 5 Percent Minoxidil to the scalp in the mornings and evenings 1 ml each time. Duration: 6 months 
Intervention  Topical Redensyl, Capixyl, Procapil combination with platelet rich plasma  Patients will receive PRP therapy once every 4 weeks (total-6 sessions) with topical medications every-day. PRP will be prepared by collecting 9ml of fresh blood in sodium citrate-containing bottles under aseptic precaution. The protocol of soft spin (2000revolution/minute for 6 minutes) and hard spin (4000revolutions/minute for 10minutes) is done. After collecting concentrated plasma, 1cc syringes are used to inject it intradermally. Patients will be instructed to use Topical Redensyl, Capixyl, Procapil combination to the scalp in the mornings and evenings 1 ml each time. Duration: 6 months  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Male 
Details  Patients with Androgenetic alopecia.
Patients who have Grade II-V AGA (According to Norwood-Hamilton Classification) 
 
ExclusionCriteria 
Details  Patients with dermatological diseases other than AGA on their head skin.
Patients with endocrine disorders, metabolic disorders, platelet disorders, hypertension, and cardiovascular problems 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the safety and effectiveness of an alternative treatment, Redensyl, Capixyl, and
Procapil (RCP) with PRP and commonly used Minoxidil 5 Percent solution with PRP in adult male patients suffering from Androgenetic Alopecia (AGA). 
Day 0, 4th week, 8th week, 12th week, 16th week, 20th week and 24th week 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   01/07/2025 
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)  Open to Recruitment 
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  

Introduction

 Androgenetic alopecia (AGA) is the most common nonscarring alopecia and is characterized by distinct gradual patterned hair loss. It is mediated by genetic predisposition and excessive follicular sensitivity to androgens, mainly in males, leading to the progressive conversion of scalp terminal hair into vellus hair. Various treatment options for AGA are available with varying efficacy. Only two drugs remain FDA approved that is Minoxidil and oral finasteride. However, although clinical studies have shown that minoxidil and finasteride have positive therapeutic outcomes, their use can have certain side-effects. Autologous platelet-rich plasma therapy has captured attention as a safe and easy method for treating AGA associated with limited side effects. Growth factors in PRP promote hair regrowth by inducing the proliferative phase of the hair follicle. The combination of Redensyl, Capixyl, and Procapil (RCP) sourced from botanical ingredients is prepared to develop a more effective treatment option for patients without side effects and thus the formula is available for long-term use. To combat AGA, combination therapy is a new dictum. Hence, in this study, we aimed to compare the safety and effectiveness of an alternative treatment, Redensyl, Capixyl, and Procapil (RCP) with PRP and commonly used Minoxidil 5%solution with PRP in adult male patients suffering from AGA.

 Study Objectives

 To compare the effectiveness and safety of topical 5% minoxidil with PRP and topical Redensyl, Capixyl and Procapil combination with PRP in adult males suffering from AGA.

JUSTIFICATION FOR STUDY

• Androgenetic alopecia is highly prevalent but not fatal but they have a significant psychosocial impact especially on females and younger males. 

• It affects the quality of life, body image, self-esteem and emotional health and may even trigger neurotic conditions like anxiety and depression. • It’s important to provide these patients with the best possible care.

• Early intervention with appropriate therapies can delay or prevent further hair loss, and ongoing research into new treatments continues to enhance the options available

METHODOLOGY:

SOURCE OF DATA: Patients visiting the Dermatology OP, CHRI. 

INCLUSION CRITERIA: • Male patients • Age: 18-55 years • Patients with Androgenetic alopecia • Patients who has Grade II-V AGA (According to Norwood-Hamilton Classification) 

EXCLUSION CRITERIA: • Patients with dermatological diseases other than AGA on their head skin • Patients with endocrine disorders,

metabolic disorders, platelet disorders, hypertension, and cardiovascular problems

• Patients who fulfil the inclusion criteria will be allocated to the study.

 •Informed consent letter will be obtained from the patient in their regional language after

explaining the study in detail to them. 

• Detailed history will be noted. 

• Patients will be graded, according to the modified Norwood-Hamilton classification (Grade 1-Grade7) Grade 7 being

severe. 

• Patients will receive PRP therapy once every 4 weeks (total-6 sessions) with topical medications every-day. PRP will be prepared by collecting 9ml of fresh blood in sodium citrate- containing bottles under aseptic precaution. The protocol of soft spin (2000revolution/minute for 6 minutes) and hard spin (4000revolutions/minute for10minutes) is done. After collecting concentrated plasma, 1cc syringes are used to inject it intradermally. • Patients will be instructed to use Topical medications to the scalp in the mornings and evenings 1 ml each time. 

• Patient will be reviewed from the start of the study and every 4 weeks after, up to 24 weeks (end of the study) 

• At each time point of the evaluation, the patients are expected to visit the clinic and the condition of their hair, the follow-up plan of their topical serum treatment, and adverse effects, if any, will be recorded.

 • Researcher will use the five-point evaluation, self-evaluation form and photographs for Global photographic evaluation 

• Five-point evaluation to assess increase in hair density, A significant recovery- Intensive hair growth A moderate recovery- Average hair growth A slight recovery-Minimal hair growth No change- No hair growth detectable, using the naked eye. Worsening-A decrease in hair growth 

• Self-evaluation form- Patients assess their scalp hair by choosing the answer for four questions on treatment efficacy and three questions on satisfaction with appearance. • Global photographic Assessment (GPA) scale will be performed during which lighting and position were identical, at the beginning of the study and at the end of 12th and 24th week visits by the researcher. Scaling includes, 0: <25% ,1: 26%-50%, 2: 51%-75%, 3: >75% • All the data collected will be entered into an excel sheet and the prevalence of basal characteristic in relation with the comparative use of both the treatment will be noted.

Study outcome or end points
To compare the safety and effectiveness of an alternative treatment, Redensyl, Capixyl, and Procapil (RCP) with PRP and commonly used Minoxidil 5%solution with PRP in adult male patients suffering from AGA.

Ethical Considerations
Any risk to the subject associated with the study: None. Maintenance of confidentiality of records: The data will be used for study purpose only and full confidentiality of the subjects will
be maintained. Provision of treatment for research related injury: None. If any complications occur, then I will provide free treatment in the hospital. Freedom of individuals to participate
and to withdraw from the research at any time with-out penalty or loss of benefits to which the subject would otherwise have been entitled- Participation in this study is voluntary.
Requirement of blood samples: Yes, blood samples are required for PRP therapy Costs and source of investigations and drugs: He/She will not be charged consultation

Study Duration: 6 Months
 
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