Androgenetic AlopeciaPhase 2/3NCT05990400
Effectiveness and Safety of Topical Finasteride and Minoxidil Combination Compared to Topical Minoxidil for The Treatment of Male Androgenetic Alopecia
A Phase 2/3 study testing Finasteride and Minoxidil in people with Androgenetic Alopecia, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
A double-blind, randomized, controlled trial of 40 male patients with androgenetic alopecia was conducted. All subject were randomized to receive either combination of minoxidil 5% topical and finasteride 0,1% topical or minoxidil 5% topical Read more about this study
- Who is it for?
- Ages 18 to 59 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Androgenetic Alopecia
- What is being tested?
- Finasteride and Minoxidil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 May 2023to 30 Dec 2023
- Phase
- Phase 2/3
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male aged from 18-59 years diagnosed with androgenic alopecia
- Androgenic alopecia type III-V according to Hamilton-Norwood criteria
- Willing to participate in this research by signing the consent form after receiving an explanation from the researcher
- Willing to not cutting the hair nor coloring the hair during the study
Who cannot join
- Diagnosed with other infectious or inflammatory skin disease in the scalp
- Using oral medications or vitamins that aim to increase the amount of hair in the last 1 month
- Using topical medication that aim to increase the amount of hair in the last 2 weeks
- Undergoing cosmetic procedure for AGA therapy such as low-level laser therapy (LLLT) procedures, platelet-rich plasma (PRP) injections, or microneedling within the last 3 months
- Have sexual disorder such as decreased libido
- Have a history of allergy or irritant contact dermatitis to the minoxidil and finasteride
Trial locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
University Indonesia
Jakarta, Other (Non U.s.), 10250
Farah F Lubis, MD, 081385088998, farahfaulinlubis@gmail.com
About this study
A double-blind, randomized, controlled trial of 40 male patients with androgenetic alopecia was conducted. All subject were randomized to receive either combination of minoxidil 5% topical and finasteride 0,1% topical or minoxidil 5% topical
Read the detailed description
All subject were randomized to receive either combination of minoxidil 5% topical and finasteride 0,1% topical or minoxidil 5% topical The primary outcome was increase of the hair density and hair diameter (mean thickness) measured by trichoscan Measurements were done at baseline and every four weeks for twelve weeks. Additionally, side effects of therapy was also measured.
- Conditions
- Androgenetic Alopecia
- Being tested
- Finasteride, Minoxidil
- Keywords
- Finasteride topical, Minoxidil topical, Male androgenetic alopecia
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FinasterideDrug
finasteride topical 0,1%
MinoxidilDrug
minoxidil topical 5%
| Study group | Role | What they receive |
|---|---|---|
| Combination of minoxidil 5% topical and finasteride 0,1% topical group | Experimental | Combination of minoxidil 5% solutio and finasteride 0,1% solutio which has administered topically Receives: Drug: Finasteride; Drug: Minoxidil |
| Minoxidil 5% topical group | Active comparator | Minoxidil 5% solutio which has administered topically Receives: Drug: Minoxidil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hair density
Density of the hair is the number of hair strands per square inch of the scalp measured by trichoscan
Measured: 4 times of measurement in 3 months
Hair diameter (mean thickness)
Hair diameter is the midline of the hair shaft measured by trichoscan
Measured: 4 times of measurement in 3 months
Side effects
Incidence of side effects
Measured: 4 times of measurement in 3 months
Secondary outcomes (3)
Velus hair percentage ( hair rate vellus)
Vellus hair is a hair that is less than 30 micrometer in diameter, lacks a medulla hair, and is 2 cm in length measured by trichoscan
Measured: 4 times of measurement in 3 months
Terminal hair percentage (hair rate terminal)
Terminal hair is a hair that has a hair more than 60 micrometer, contains the medulla and can be up to 100 cm in length measured by trichoscan
Measured: 4 times of measurement in 3 months
Dermoscopy
Dermoscopy is a non-invasive technique that allows more detailed examination of the scalp and hair shaft under magnification
Measured: 4 times of measurement in 3 months
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 May 2023
- Primary completion30 Oct 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible subjects were randomized to receive either combination of minoxidil 5% topical and finasteride 0,1% topical or minoxidil 5% topical. The allocation sequence was generated with a computer by an analyst.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Farah Faulin Al Fauz Lubis, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05990400
- Sponsor's protocol ID
- 23030293
- Status last verified
- Sep 2023
- First submitted
- 4 Aug 2023
- Last updated
- 22 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Topical Finasteride and Minoxidil Combination Compared to Topical Minoxidil for The Treatment of Male Androgenetic Alopecia
- ClinicalTrials.gov ID
- NCT05990400
- Acronym / sponsor ID
- 23030293
- Conditions
- Androgenetic Alopecia
- Keywords
- Finasteride topical, Minoxidil topical, Male androgenetic alopecia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Oct 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- 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.
A double-blind, randomized, controlled trial of 40 male patients with androgenetic alopecia was conducted. All subject were randomized to receive either combination of minoxidil 5% topical and finasteride 0,1% topical or minoxidil 5% topical
Detailed description
All subject were randomized to receive either combination of minoxidil 5% topical and finasteride 0,1% topical or minoxidil 5% topical The primary outcome was increase of the hair density and hair diameter (mean thickness) measured by trichoscan Measurements were done at baseline and every four weeks for twelve weeks. Additionally, side effects of therapy was also measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Eligible subjects were randomized to receive either combination of minoxidil 5% topical and finasteride 0,1% topical or minoxidil 5% topical. The allocation sequence was generated with a computer by an analyst.
| Arm | Type | Receives |
|---|---|---|
| Combination of minoxidil 5% topical and finasteride 0,1% topical group | Experimental | Drug: Finasteride, Drug: MinoxidilCombination of minoxidil 5% solutio and finasteride 0,1% solutio which has administered topically |
| Minoxidil 5% topical group | Active comparator | Drug: MinoxidilMinoxidil 5% solutio which has administered topically |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male aged from 18-59 years diagnosed with androgenic alopecia
- Androgenic alopecia type III-V according to Hamilton-Norwood criteria
- Willing to participate in this research by signing the consent form after receiving an explanation from the researcher
- Willing to not cutting the hair nor coloring the hair during the study
Key exclusion criteria (6 listed)
- Diagnosed with other infectious or inflammatory skin disease in the scalp
- Using oral medications or vitamins that aim to increase the amount of hair in the last 1 month
- Using topical medication that aim to increase the amount of hair in the last 2 weeks
- Undergoing cosmetic procedure for AGA therapy such as low-level laser therapy (LLLT) procedures, platelet-rich plasma (PRP) injections, or microneedling within the last 3 months
- Have sexual disorder such as decreased libido
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 |
|---|---|---|
| Finasteridefinasteride topical 0,1% | Drug | Combination of minoxidil 5% topical and finasteride 0,1% topical group |
| Minoxidilminoxidil topical 5% | Drug | Combination of minoxidil 5% topical and finasteride 0,1% topical group, Minoxidil 5% topical group |
Primary outcome
Hair density
Time frame: 4 times of measurement in 3 months
Density of the hair is the number of hair strands per square inch of the scalp measured by trichoscan
Hair diameter (mean thickness)
Time frame: 4 times of measurement in 3 months
Hair diameter is the midline of the hair shaft measured by trichoscan
Side effects
Time frame: 4 times of measurement in 3 months
Incidence of side effects
3 secondary outcomes
Velus hair percentage ( hair rate vellus)
Time frame: 4 times of measurement in 3 months
Terminal hair percentage (hair rate terminal)
Time frame: 4 times of measurement in 3 months
Dermoscopy
Time frame: 4 times of measurement in 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Finasteride and 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 4 inclusion and 6 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 22 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Farah F Lubis, MD (081385088998, farahfaulinlubis@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hair density (time frame: 4 times of measurement in 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Sep 2023.