Effectiveness and Safety of Platelet-rich Plasma and Topical 5% Minoxidil Combination in Male Androgenetic Alopecia
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ClinicalTrials.gov Identifier: NCT06043349 |
Recruitment Status :
Active, not recruiting
First Posted : September 21, 2023
Last Update Posted : September 21, 2023
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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 |
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Androgenetic Alopecia | Combination Product: Platelet-Rich Plasma and Topical 5% Minoxidil Drug: Topical 5% Minoxidil | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
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. |
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 : | June 1, 2023 |
Actual Primary Completion Date : | September 1, 2023 |
Estimated Study Completion Date : | September 30, 2023 |
Arm | Intervention/treatment |
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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.
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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.
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Drug: Topical 5% Minoxidil
The intervention group will receive topical 5% minoxidil as standard therapy for male androgenetic alopecia. |
- 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
- 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".
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | Male |
Gender Based Eligibility: | Yes |
Gender Eligibility Description: | Male patient with androgenetic alopecia |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06043349
Indonesia | |
Dr. Cipto Mangunkusumo National General Hospital | |
Jakarta Pusat, Greater Jakarta Area, Indonesia, 10430 |
Principal Investigator: | Adhika A Lestari, MD | Faculty of Medicine, University of Indonesia |
Other Publications:
Responsible Party: | Adhika Ayu Lestari, MD, Indonesia University |
ClinicalTrials.gov Identifier: | NCT06043349 |
Other Study ID Numbers: |
23020292 |
First Posted: | September 21, 2023 Key Record Dates |
Last Update Posted: | September 21, 2023 |
Last Verified: | September 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Platelet-Rich Plasma Topical Minoxidil Combination Therapy |
Alopecia Alopecia Areata Hypotrichosis Hair Diseases Skin Diseases |
Pathological Conditions, Anatomical Minoxidil Antihypertensive Agents Vasodilator Agents |