Androgenetic AlopeciaPhase 3NCT05989165
Effectiveness of Combination Therapy of Microneedling and Minoxidil in Androgenetic Alopecia of Indonesian Men
A Phase 3 study testing Minoxidil 5% Topical Solution and microneedling in people with Androgenetic Alopecia, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
The goal of this clinical trial is to compare the effectiveness of combination therapy of microneedling and minoxidil in androgenetic alopecia of Indonesian men. The main questions it aims to answer are: Is there an increase in hair density with combination therapy of microneedling and minoxidil versus minoxidil… Read more about this study
- Who is it for?
- Ages 18 to 59 years, men only
- Conditions the study is for
- Androgenetic Alopecia
- What is being tested?
- Minoxidil 5% Topical Solution and microneedling
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jun 2023to 15 Sep 2023
- Phase
- Phase 3
- 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 59 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Male
- Indonesian
- Age 18-59 years
- Diagnosis of androgenetic alopecia
- Hamilton-Norwood type III-IV
Who cannot join
- Use of minoxidil or finasteride topical 1 month prior
- Use of minoxidil or finasteride oral 1 month prior
- Skin infection in the treatment area
- Cosmetic procedures for the treatment of alopecia androgenetic such as platelet rich plasma, laser therapy,or microneedling 3 months prior
- History of keloid
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to compare the effectiveness of combination therapy of microneedling and minoxidil in androgenetic alopecia of Indonesian men. The main questions it aims to answer are:
- Is there an increase in hair density with combination therapy of microneedling and minoxidil versus minoxidil monotherapy?
- Is there an increase in hair diameter with combination therapy of microneedling and minoxidil versus minoxidil monotherapy?
Participants will be divided into 2 groups. The first one will receive minoxidil monotherapy, and the second one will receive a combination therapy of microneedling and minoxidil. Researchers will compare those 2 groups to see if there is a difference of effectiveness based on hair density and diameter.
- Conditions
- Androgenetic Alopecia
- Being tested
- Minoxidil 5% Topical Solution, microneedling
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minoxidil 5% Topical SolutionDrug
Patient will be given minoxidil 5% topical solution, twice a day for 12 weeks
microneedlingDevice
Patient will be given microneedling treatment every 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Minoxidil 5% solution | Experimental | Patients will receive minoxidil 5%, twice a day, for a total duration of 12 weeks. Receives: Drug: Minoxidil 5% Topical Solution |
| Combination therapy of microneedling and minoxidil 5% solution | Experimental | Patients will receive a combination therapy of microneedling and minoxidil 5%. Minoxidil 5%, will be given twice a day for a total duration of 12 weeks. The microneedling treatment will be given every 4 weeks (week 0, week 4, week 8)for a total duration of 12 weeks. Receives: Drug: Minoxidil 5% Topical Solution; Device: microneedling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Density of hair
Increase density of hair in alopecia androgenetic patient
Measured: 12 weeks
Diameter of hair
Increase diameter of hair in alopecia androgenetic patient
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start1 Jun 2023
- Primary completion1 Sep 2023
- Study completion15 Sep 2023
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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, Kara Adistri, Universitas Indonesia
- Investigators
- Kara Adistri, MD, Principal investigator, Faculty of medicine, University of Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05989165
- Sponsor's protocol ID
- 23030294
- Status last verified
- Sep 2023
- First submitted
- 3 Aug 2023
- Last updated
- 28 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dhurat R, Sukesh M, Avhad G, Dandale A, Pal A, Pund P. A randomized evaluator blinded study of effect of microneedling in androgenetic alopecia: a pilot study. Int J Trichology. 2013 Jan;5(1):6-11. doi: 10.4103/0974-7753.114700.
PubMed 23960389Kumar MK, Inamadar AC, Palit A. A Randomized Controlled, Single-Observer Blinded Study to Determine the Efficacy of Topical Minoxidil plus Microneedling versus Topical Minoxidil Alone in the Treatment of Androgenetic Alopecia. J Cutan Aesthet Surg. 2018 Oct-Dec;11(4):211-216. doi: 10.4103/JCAS.JCAS_130_17.
PubMed 30886475
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Combination Therapy of Microneedling and Minoxidil in Androgenetic Alopecia of Indonesian Men
- ClinicalTrials.gov ID
- NCT05989165
- Acronym / sponsor ID
- 23030294
- Conditions
- Androgenetic Alopecia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- 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
- 15 Sep 2023 (actual)
- First posted
- 14 Aug 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 compare the effectiveness of combination therapy of microneedling and minoxidil in androgenetic alopecia of Indonesian men. The main questions it aims to answer are:
- Is there an increase in hair density with combination therapy of microneedling and minoxidil versus minoxidil monotherapy?
- Is there an increase in hair diameter with combination therapy of microneedling and minoxidil versus minoxidil monotherapy?
Participants will be divided into 2 groups. The first one will receive minoxidil monotherapy, and the second one will receive a combination therapy of microneedling and minoxidil. Researchers will compare those 2 groups to see if there is a difference of effectiveness based on hair density and diameter.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minoxidil 5% solution | Experimental | Drug: Minoxidil 5% Topical SolutionPatients will receive minoxidil 5%, twice a day, for a total duration of 12 weeks. |
| Combination therapy of microneedling and minoxidil 5% solution | Experimental | Drug: Minoxidil 5% Topical Solution, Device: microneedlingPatients will receive a combination therapy of microneedling and minoxidil 5%. Minoxidil 5%, will be given twice a day for a total duration of 12 weeks. The microneedling treatment will be given every 4 weeks (week 0, week 4, week 8)for a total duration of 12 weeks. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male
- Indonesian
- Age 18-59 years
- Diagnosis of androgenetic alopecia
- Hamilton-Norwood type III-IV
Key exclusion criteria (5 listed)
- Use of minoxidil or finasteride topical 1 month prior
- Use of minoxidil or finasteride oral 1 month prior
- Skin infection in the treatment area
- Cosmetic procedures for the treatment of alopecia androgenetic such as platelet rich plasma, laser therapy,or microneedling 3 months prior
- History of keloid
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 |
|---|---|---|
| Minoxidil 5% Topical SolutionPatient will be given minoxidil 5% topical solution, twice a day for 12 weeks | Drug | Combination therapy of microneedling and minoxidil 5% solution, Minoxidil 5% solution |
| microneedlingPatient will be given microneedling treatment every 4 weeks | Device | Combination therapy of microneedling and minoxidil 5% solution |
Primary outcome
Density of hair
Time frame: 12 weeks
Increase density of hair in alopecia androgenetic patient
Diameter of hair
Time frame: 12 weeks
Increase diameter of hair in alopecia androgenetic patient
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Results publication: PubMed 23960389Dhurat R, Sukesh M, Avhad G, Dandale A, Pal A, Pund P. A randomized evaluator blinded study of effect of microneedling in androgenetic alopecia: a pilot study. Int J Trichology. 2013 Jan;5(1):6-11. doi: 10.4103/0974-7753.114700.
- Results publication: PubMed 30886475Kumar MK, Inamadar AC, Palit A. A Randomized Controlled, Single-Observer Blinded Study to Determine the Efficacy of Topical Minoxidil plus Microneedling versus Topical Minoxidil Alone in the Treatment of Androgenetic Alopecia. J Cutan Aesthet Surg. 2018 Oct-Dec;11(4):211-216. doi: 10.4103/JCAS.JCAS_130_17.
- 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.
Kara Adistri, 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 3 study testing Minoxidil 5% Topical Solution and microneedling 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 28 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Density of hair (time frame: 12 weeks). 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 NCT05989165, 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 28 Sep 2023.