Clinical trial

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

Name
23020292
Description
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?
Trial arms
Trial start
2023-06-01
Estimated PCD
2023-09-01
Trial end
2023-09-30
Status
Active (not recruiting)
Phase
Early phase I
Treatment
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.
Arms:
Intervention Group
Topical 5% Minoxidil
The intervention group will receive topical 5% minoxidil as standard therapy for male androgenetic alopecia.
Arms:
Control Group
Size
36
Primary endpoint
Hair Density
Three months
Hair Thickness
Three months
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 36, 'type': 'ACTUAL'}}
Updated at
2023-09-21

1 organization

2 products

1 indication

Product
Minoxidil