Effectiveness and Safety of Platelet-rich Plasma and Topical 5% Minoxidil Combination in Male Androgenetic Alopecia

Phase 4

Active, not recruiting

• Conditions: Androgenetic Alopecia
• Interventions: Combination Product: Platelet-Rich Plasma and Topical 5% Minoxidil; Drug: Topical 5% Minoxidil

• Registration Number: NCT06043349
• Lead Sponsor: Indonesia University

Brief Summary

The goal of this clinical trial is to learn about the effectiveness and safety of platelet-rich plasma (PRP) and topical 5% minoxidil combination therapy compared with topical 5% minoxidil monotherapy in male androgenetic alopecia.

The main questions it aims to answer are:

* Is there a difference in average change of hair density between groups that were given a combination of PRP injection and topical minoxidil compared to topical minoxidil as monotherapy?

* Is there a difference in average change of hair thickness between groups that were given a combination of PRP and topical minoxidil compared to topical minoxidil as monotherapy?

* Are there any differences in side effects between groups that were given combination of PRP and topical minoxidil compared to topical minoxidil as monotherapy?

Detailed Description

The trial will be held for three months in Jakarta, Indonesia. Participants are required to undergo hair examinations every 4 weeks, for a total of 4 visits. Researchers will compare groups that were given a combination of PRP and topical minoxidil compared to topical minoxidil alone as a control group. Hair density, hair thickness, and overall side effects of treatment will be measured at each visit.

Study Timeline

• Study Start: 2023-06-01
• Status Verified: 2023-09
• Primary Completion: 2023-09-01
• Study First Submitted: 2023-09-06
• Study First Submitted QC: 2023-09-12
• Last Update Submitted: 2023-09-12
• Study First Posted: 2023-09-21
• Last Update Posted: 2023-09-21
• Study Completion: 2023-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 36

Inclusion Criteria

• Men between 18 and 50 years old
• Diagnosed with grade III-VI androgenetic alopecia based on Hamilton-Norwood scale
• Willing to be the research subject and make regular follow-up visits.

Exclusion Criteria

• Conditions of baldness other than androgenetic alopecia based on anamnesis and physical examination, namely telogen effluvium, alopecia areata, trichotillomania, syphilis secondary, systemic lupus erythematosus, alopecia due to chemotherapy, autoimmune, or malignancy.
• Taking oral medications or vitamins that aim to increase the amount of hair in the last 1 month.
• Using topical medication that aims to increase the amount of hair in the last 2 weeks.
• Suffering from active bacterial, viral, or fungal infections of the scalp.
• Underwent cosmetic procedures for androgenetic alopecia treatment (such as PRP injections, laser procedures, or microneedle) within the last 3 months prior to the study.
• History of keloids.
• History of blood clotting disorders.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Platelet-Rich Plasma and Topical 5% Minoxidil	The first group, called the intervention group, will receive a combination therapy of platelet-rich plasma injection (PRP) with topical 5% minoxidil for three months. PRP injection will be given every 4 weeks with a total of three injections. Respondents will be instructed to apply topical minoxidil twice daily for three months.
Control Group	Topical 5% Minoxidil	The second group (control group) will receive topical 5% minoxidil as standard therapy. Respondents will be instructed to apply topical minoxidil twice daily for three months.

Primary Outcome Measures

Name	Time	Method
Hair Density	Three months	Change in average hair density will be reported in /cm2
Hair Thickness	Three months	Change in average hair thickness will be reported in milimeters

Secondary Outcome Measures

Name	Time	Method
Subjective side effects	Three months	The patients subjective side effects from both intervention and control group will be reported using questionnaire during follow-up visits. Subjective side effects which will be reported consist of pain, itch, and burning sensation. Each subjective complaint will be reported as "Yes" or "No". Other subjective side effects, if any, will also be noted under the term "Other".
Objective side effects	Three months	Researcher will report any objective side effects found during follow-up visits. The main objective side effects that will be reported are erythema and hypertrichosis. Each finding will be reported as "Yes" or "No". Other objective side effects, if any, will be noted under the term "Other".

Trial Locations

Locations (1)

Dr. Cipto Mangunkusumo National General Hospital; 🇮🇩 Jakarta Pusat, Greater Jakarta Area, Indonesia