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.

Recruiting

Conditions: Androgenic alopecia, unspecified,

Registration Number: CTRI/2025/06/088077

Lead Sponsor: Dr J Mirudula Josena

Brief Summary: Introduction

Androgenetic alopecia (AGA) is the most common nonscarringalopecia and is characterized by distinct gradual patterned hair loss. It is mediated bygenetic predisposition and excessive follicular sensitivity to androgens, mainly in males,leading to the progressive conversion of scalp terminal hair into vellus hair. Various treatmentoptions for AGA are available with varying efficacy. Only two drugs remain FDA approved that isMinoxidil and oral finasteride. However, although clinical studies have shown that minoxidil andfinasteride 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 treatingAGA associated with limited side effects. Growth factors in PRP promote hair regrowth byinducing the proliferative phase of the hair follicle. The combination of Redensyl, Capixyl, andProcapil (RCP) sourced from botanical ingredients is prepared to develop a more effectivetreatment 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 tocompare 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 malepatients 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 adultmales suffering from AGA.

JUSTIFICATION FOR STUDY

• Androgenetic alopecia is highlyprevalent but not fatal but they have a significant psychosocial impact especially on femalesand younger males.

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

• Early intervention with appropriatetherapies can delay or prevent further hair loss, and ongoing research into new treatments continues toenhance 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

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Male

Target Recruitment: 50

Inclusion Criteria

Patients with Androgenetic alopecia.
Patients who have 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the safety and effectiveness of an alternative treatment, Redensyl, Capixyl, and	Day 0, 4th week, 8th week, 12th week, 16th week, 20th week and 24th week
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 Measures

Name	Time	Method

Trial Locations

Locations (1): Chettinad Hospital and Research Institute, Chettinad Academy of Research and Education
🇮🇳
Chennai, TAMIL NADU, India
Chettinad Hospital and Research Institute, Chettinad Academy of Research and Education
🇮🇳Chennai, TAMIL NADU, India
Dr J Mirudula Josena
Principal investigator
hod.dermatology@care.edu.in