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

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Primary Purpose

Status

Active

Phase

Phase 4

Locations

Indonesia

Study Type

Interventional

Intervention

Platelet-Rich Plasma and Topical 5% Minoxidil

Topical 5% Minoxidil

About this trial

This is an interventional treatment trial for Androgenetic Alopecia focused on measuring Platelet-Rich Plasma, Topical Minoxidil, Combination Therapy

Eligibility Criteria

18 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

Dr. Cipto Mangunkusumo National General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Hair Density

Change in average hair density will be reported in /cm2

Hair Thickness

Change in average hair thickness will be reported in milimeters

Secondary Outcome Measures

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".

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".

Full Information

NCT ID

NCT06043349

First Posted

September 6, 2023

Last Updated

September 12, 2023

Sponsor

Indonesia University

1. Study Identification

Unique Protocol Identification Number

NCT06043349

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

June 1, 2023 (Actual)

Primary Completion Date

September 1, 2023 (Actual)

Study Completion Date

September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Indonesia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

5. 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?

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Androgenetic Alopecia

Keywords

Platelet-Rich Plasma, Topical Minoxidil, Combination Therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

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)

Allocation

Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention Group

Arm Type

Experimental

Arm Description

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.

Arm Title

Control Group

Arm Type

Active Comparator

Arm Description

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 Type

Combination Product

Intervention Name(s)

Platelet-Rich Plasma and Topical 5% Minoxidil

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Topical 5% Minoxidil

Intervention Description

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

Primary Outcome Measure Information:

Title

Hair Density

Description

Change in average hair density will be reported in /cm2

Time Frame

Three months

Title

Hair Thickness

Description

Change in average hair thickness will be reported in milimeters

Time Frame

Three months

Secondary Outcome Measure Information:

Title

Subjective side effects

Description

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".

Time Frame

Three months

Title

Objective side effects

Description

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".

Time Frame

Three months

10. Eligibility

Sex

Male

Gender Based

Yes

Gender Eligibility Description

Male patient with androgenetic alopecia

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Adhika A Lestari, MD

Organizational Affiliation

Faculty of Medicine, University of Indonesia

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dr. Cipto Mangunkusumo National General Hospital

City

Jakarta Pusat

State/Province

Greater Jakarta Area

ZIP/Postal Code

10430

Country

Indonesia

12. IPD Sharing Statement

Plan to Share IPD

No

Citations:

PubMed Identifier

35300100

Citation

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.

Results Reference

background

PubMed Identifier

31823902

Citation

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.

Results Reference

result

Androgenetic Alopecia

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial