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

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

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?

Study Overview

• Status: Active, not recruiting
• Conditions: Androgenetic Alopecia
• Intervention / Treatment: Combination product: Platelet-Rich Plasma and Topical 5% Minoxidil; Drug: Topical 5% Minoxidil

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 Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 4

Contacts and Locations

Study Locations

• Indonesia
  • Greater Jakarta Area
    • Jakarta Pusat, Greater Jakarta Area, Indonesia, 10430
      • Dr. Cipto Mangunkusumo National General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hair Density	Change in average hair density will be reported in /cm2	Three months
Hair Thickness	Change in average hair thickness will be reported in milimeters	Three months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective side effects	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".	Three months
Objective side effects	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".	Three months

Collaborators and Investigators

• Sponsor: Indonesia University
• Investigators: Principal Investigator: Adhika A Lestari, MD, Faculty of medicine, University of Indonesia

Publications and helpful links

General Publications

• Elena EP, Irina OS. Combination therapy with platelet-rich plasma and minoxidil leads to better clinical results than monotherapy with these methods in men with androgenetic alopecia. Int J Trichology. 2022 Jan-Feb;14(1):1-7. doi: 10.4103/ijt.ijt_50_19. Epub 2022 Feb 1.
• Singh SK, Kumar V, Rai T. Comparison of efficacy of platelet-rich plasma therapy with or without topical 5% minoxidil in male-type baldness: A randomized, double-blind placebo control trial. Indian J Dermatol Venereol Leprol. 2020 Mar-Apr;86(2):150-157. doi: 10.4103/ijdvl.IJDVL_589_18.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Actual): September 1, 2023
• Study Completion (Estimated): September 30, 2023

Study Registration Dates

• First Submitted: September 6, 2023
• First Submitted That Met QC Criteria: September 12, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 12, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Combination Therapy; Platelet-Rich Plasma; Topical Minoxidil
• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata; Antihypertensive Agents; Vasodilator Agents; Minoxidil
• Other Study ID Numbers: 23020292

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No