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

• ClinicalTrials.gov Identifier: NCT06043349
• Recruitment Status: Active, not recruiting
• First Posted: September 21, 2023
• Last Update Posted: September 21, 2023
• Sponsor: Indonesia University
• Information provided by (Responsible Party): Adhika Ayu Lestari, Indonesia University

Tracking Information

• First Submitted Date: September 6, 2023
• First Posted Date: September 21, 2023
• Last Update Posted Date: September 21, 2023
• Actual Study Start Date: June 1, 2023
• Actual Primary Completion Date: September 1, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 12, 2023)

• Hair Density [ Time Frame: Three months ]
  Change in average hair density will be reported in /cm2
• Hair Thickness [ Time Frame: Three months ]
  Change in average hair thickness will be reported in milimeters

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: September 12, 2023)

• Subjective side effects [ Time Frame: 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 [ Time Frame: 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".

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

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 Type: Interventional
• Study Phase: Phase 4

Study Design

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.

Masking: None (Open Label)
Primary Purpose: Treatment

• Condition: Androgenetic Alopecia

Intervention

• 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.
• Drug: Topical 5% Minoxidil
  The intervention group will receive topical 5% minoxidil as standard therapy for male androgenetic alopecia.

Study Arms

• 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.
  Intervention: Combination Product: Platelet-Rich Plasma and 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.
  Intervention: Drug: Topical 5% Minoxidil

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.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: September 12, 2023): 36
• Original Actual Enrollment: Same as current
• Estimated Study Completion Date: September 30, 2023
• Actual Primary Completion Date: September 1, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: Male
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Male patient with androgenetic alopecia

• Ages: 18 Years to 50 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Indonesia

Administrative Information

• NCT Number: NCT06043349
• Other Study ID Numbers: 23020292
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Adhika Ayu Lestari, Indonesia University
• Original Responsible Party: Same as current
• Current Study Sponsor: Indonesia University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Adhika A Lestari, MD; Faculty of Medicine, University of Indonesia

• PRS Account: Indonesia University
• Verification Date: September 2023