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

Sponsor

Indonesia University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT06043349

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

9.1

Patients Per Site Per Month

Study Details

Study Description

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?

Condition or Disease	Intervention/Treatment	Phase
Androgenetic Alopecia	Combination Product: Platelet-Rich Plasma and Topical 5% Minoxidil Drug: Topical 5% Minoxidil	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

This study is a controlled clinical trial on male androgenetic alopecia. Research subjects will be randomly divided into two groups. The first group will receive a combination therapy of PRP injection and topical 5% minoxidil, while the second group will receive topical 5% minoxidil as monotherapy.This study is a controlled clinical trial on male androgenetic alopecia. Research subjects will be randomly divided into two groups. The first group will receive a combination therapy of PRP injection and topical 5% minoxidil, while the second group will receive topical 5% minoxidil as monotherapy.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 1, 2023

Actual Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Sep 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Group 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.	Combination Product: Platelet-Rich Plasma and Topical 5% Minoxidil The intervention group will receive three PRP injections during three months in addition to the topical 5% minoxidil.
Active Comparator: Control Group 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.	Drug: Topical 5% Minoxidil The intervention group will receive topical 5% minoxidil as standard therapy for male androgenetic alopecia.

Arm

Intervention/Treatment

Experimental: Intervention Group

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.

Combination Product: Platelet-Rich Plasma and Topical 5% Minoxidil

The intervention group will receive three PRP injections during three months in addition to the topical 5% minoxidil.

Active Comparator: Control Group

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.

Drug: Topical 5% Minoxidil

The intervention group will receive topical 5% minoxidil as standard therapy for male androgenetic alopecia.

Outcome Measures

Primary Outcome Measures

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

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".

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.