Androgenetic AlopeciaPhase 4NCT06043349
Effectiveness and Safety of Platelet-rich Plasma and Topical 5% Minoxidil Combination in Male Androgenetic Alopecia
A Phase 4 study testing Platelet-Rich Plasma and Topical 5% Minoxidil and Topical 5% Minoxidil in people with Androgenetic Alopecia, run by Universitas Indonesia at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Androgenetic Alopecia
- What is being tested?
- Platelet-Rich Plasma and Topical 5% Minoxidil and Topical 5% Minoxidil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jun 2023to 30 Sep 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Dr. Cipto Mangunkusumo National General Hospital
Jakarta Pusat, Greater Jakarta Area, 10430
About this study
Official title: Effectiveness and Safety of Platelet-rich Plasma and Topical 5% Minoxidil Combination Compared to Topical 5% Minoxidil Monotherapy in Male Androgenetic Alopecia
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?
Read the 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.
- Conditions
- Androgenetic Alopecia
- Being tested
- Platelet-Rich Plasma and Topical 5% Minoxidil, Topical 5% Minoxidil
- Keywords
- Platelet-Rich Plasma, Topical Minoxidil, Combination Therapy
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet-Rich Plasma and Topical 5% MinoxidilCombination product
The intervention group will receive three PRP injections during three months in addition to the topical 5% minoxidil.
Topical 5% MinoxidilDrug
The intervention group will receive topical 5% minoxidil as standard therapy for male androgenetic alopecia.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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. Receives: Combination Product: Platelet-Rich Plasma and Topical 5% Minoxidil |
| Control Group | Active comparator | 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. Receives: Drug: Topical 5% Minoxidil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hair Density
Change in average hair density will be reported in /cm2
Measured: Three months
Hair Thickness
Change in average hair thickness will be reported in milimeters
Measured: Three months
Secondary outcomes (2)
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".
Measured: Three months
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".
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start1 Jun 2023
- Primary completion1 Sep 2023
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Androgenetic AlopeciaStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adhika Ayu Lestari, Universitas Indonesia
- Investigators
- Adhika A Lestari, MD, Principal investigator, Faculty of Medicine, University of Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06043349
- Sponsor's protocol ID
- 23020292
- Status last verified
- Sep 2023
- First submitted
- 6 Sep 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 35300100Singh 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.
PubMed 31823902
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Platelet-rich Plasma and Topical 5% Minoxidil Combination Compared to Topical 5% Minoxidil Monotherapy in Male Androgenetic Alopecia
- ClinicalTrials.gov ID
- NCT06043349
- Acronym / sponsor ID
- 23020292
- Conditions
- Androgenetic Alopecia
- Keywords
- Platelet-Rich Plasma, Topical Minoxidil, Combination Therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Combination Product: Platelet-Rich Plasma and Topical 5% MinoxidilThe 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. |
| Control Group | Active comparator | Drug: Topical 5% MinoxidilThe 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platelet-Rich Plasma and Topical 5% MinoxidilThe intervention group will receive three PRP injections during three months in addition to the topical 5% minoxidil. | Combination product | Intervention Group |
| Topical 5% MinoxidilThe intervention group will receive topical 5% minoxidil as standard therapy for male androgenetic alopecia. | Drug | Control Group |
Primary outcome
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
2 secondary outcomes
Subjective side effects
Time frame: Three months
Objective side effects
Time frame: Three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Background: PubMed 35300100Elena 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 publication: PubMed 31823902Singh 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adhika A Lestari, MD principal investigator
Faculty of Medicine, University of Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Platelet-Rich Plasma and Topical 5% Minoxidil and Topical 5% Minoxidil in people with Androgenetic Alopecia, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hair Density (time frame: Three months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06043349, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.