Androgenetic Alopecia
Conditions
Keywords
Platelet-Rich Plasma, Topical Minoxidil, Combination Therapy
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.
Interventions
COMBINATION_PRODUCTPlatelet-Rich Plasma and Topical 5% Minoxidil
The intervention group will receive three PRP injections during three months in addition to the topical 5% minoxidil.
DRUGTopical 5% Minoxidil
The intervention group will receive topical 5% minoxidil as standard therapy for male androgenetic alopecia.
Sponsors
Indonesia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hair Density | Three months | Change in average hair density will be reported in /cm2 |
| Hair Thickness | Three months | Change in average hair thickness will be reported in milimeters |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective side effects | 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 | 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. |
Countries
Indonesia
Outcome results
None listed