Androgenetic Alopecia (AGA)NCT07018349
Low Dose Oral Minoxdil in Androgenic Alopecia
A study testing 2.5% Oral minoxidil and 1% Oral Minoxidil in people with Androgenetic Alopecia (AGA), run by Jinnah Postgraduate Medical Centre at 1 site in Pakistan.
Trial summary
In order to successfully treat androgenetic alopecia (AGA), this study compares the efficacy of low-dose oral minoxidil dosages of 0.25 mg and 1 mg. It addresses a critical gap in current research, as few studies have examined the relationship between low dosage and outcomes like hair diameter, density, patient… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Androgenetic Alopecia (AGA)
- What is being tested?
- 2.5% Oral minoxidil and 1% Oral Minoxidil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jun 2025to 20 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients have a clinical and trichoscopic diagnosis of mild to severe AGA
Who cannot join
- Patients who, within three months before the trial, had undergone systemic or topical therapies for AGA
- People who suffer from additional hair loss conditions such hyperandrogenism, scarring or inflammatory alopecia, or any hormonal disorders.
- Sensitivity to minoxidil
- Patients with history of severe systemic diseases (heart, renal, or hepatic), a history of hypertension or hypotension, pregnant and breast-feeding women will also be excluded.
- Patient who will not be willing to provide written informed consents.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
In order to successfully treat androgenetic alopecia (AGA), this study compares the efficacy of low-dose oral minoxidil dosages of 0.25 mg and 1 mg. It addresses a critical gap in current research, as few studies have examined the relationship between low dosage and outcomes like hair diameter, density, patient satisfaction, and adverse effects, including hypertrichosis. Previous research suggests that low dose of oral minoxidil is a safe and well-tolerated option for hair loss, but the optimal dose for maximizing benefits while minimizing side effects remains unclear. This study aims to determine which dose offers the best balance of efficacy and safety for AGA patients.
Read the detailed description
The most prevalent kind of progressive hair loss, androgenetic alopecia (AGA), is becoming more prevalent with growing age. AGA can affect a person's quality of life. For men, it shows up as a noticeable receding frontal hairline, whereas for women, it shows up as overall hair loss with frontal hairline retention. The primary causes of the condition are 5-alpha-reductase and dihydrotestosterone (DHT), which shorten anagen cycles and decrease hair follicles. It is still unclear whether precise processes underlie AGA start and vulnerability. AGA is thought to be a polygenic disorder whose onset and progression are influenced by the interplay of environmental, endocrine, and genetic variables. Several studies have shown that AGA negatively impacts on the quality of life (QoL) and self-esteem of the patients. However, because patients' expectations of treatment outcomes are typically higher than reality, AGA has continued to be a therapeutic problem for dermatologists.
FDA-approved treatment managements for AGA at present include oral finasteride, topical minoxidil 2%-5%, and low-level light therapy. The most often recommended drug among them is topical minoxidil solution. The selection of treatments for androgenetic alopecia therapy is still difficult as it requires moral, evidence-based judgment and takes into account the demands, compliance, financial constraints, degree of hair loss, and cosmetic preferences of each patient. Despite the fact that there are several medication, surgery, light-based, and nutraceutical treatment options available to stop or reverse the progression of AGA, selecting the best treatments for this chronic condition can be challenging. This study aims to determine which dose offers the best balance of efficacy and safety for AGA patients.
This study will be an RCT study. All patients will be adequately informed about the treatment regimen, follow-ups, and likely adverse effects before the start of the study. A written consent form will be obtained from each patient.
The study's eligibility for participation will be assessed for patients with AGA with the severity ranging from mild to moderate AGA. All AGA patients will get a trichoscopy and a complete scalp examination on their first appointment in order to rule out other hair-loss conditions, such as other types of alopecia like scarring or inflammatory and alopecia areata. Each patient's AGA stage will then be ascertained using the Savin scale for female patients and the "Norwood Hamilton scale" for male patients. Individuals who meet the clinical and trichoscopic criteria for mild to moderate AGA will be assessed for trial eligibility. Before beginning therapy, testing for hematological disorders, liver, kidney, thyroid, electrolytes, and pregnancy will be conducted. At 3-month follow-up appointment, measurements of body weight and blood pressure will also be taken.
AGA patients will be randomly allocated in both groups using the envelopes method to reduce the biasness. For 3-months, patients in Group-A will get 2.5mg of minoxidil once daily, while those in Group-B will receive 1mg of minoxidil once daily orally. After starting therapy, patients will be asked to come back for evaluations 3 months later. Safety, satisfaction, and the effects of the treatment will be reported. Final outcomes will be evaluated at 3 months post treatment.
- Conditions
- Androgenetic Alopecia (AGA)
- Being tested
- 2.5% Oral minoxidil, 1% Oral Minoxidil
- Keywords
- androgenetic alopecia (AGA), Minoxdil, Low oral doses
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2.5% Oral minoxidilDrug
AGA patients will be randomly allocated in both groups using the envelopes method to reduce the biasness. For 3-months, patients in Group-A will get 2.5mg of minoxidil once daily, while those in Group-B will receive 1mg of minoxidil once daily orally. After starting therapy, patients will be asked to come back for evaluations 3 months later. Safety, satisfaction, and the effects of the treatment will be reported. Final outcomes will be evaluated at 3 months post treatment.
1% Oral MinoxidilDrug
Group-B will receive 1mg of minoxidil once daily orally
| Study group | Role | What they receive |
|---|---|---|
| Oral Minoxidil 2.5% mg | Experimental | Group-A: 2.5% mg of minoxidil once daily, orally. Receives: Drug: 2.5% Oral minoxidil |
| Oral Minoxidil 1% mg | Experimental | Group-B: 1% mg of minoxidil once daily orally. Receives: Drug: 1% Oral Minoxidil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hair count and Thickness
Three distinct areas of the scalp will be marked with jet black Micropigment to guarantee precise measurements. These sites, which will be called the vertex points, mid-frontal, and frontal, respectively, were situated 12, 16, and 24 cm from the glabella. Following the application of just one drop of pigment to the selected area, the ink will be tattooed onto the skin using an insulin needle. The tattooed regions were photographed from a distance using a dermoscopic gadget (FotoFinder System Gmbh) that was linked to a camera (Canon EOS M100 DSLR) and a mobile phone. A trichology-trained technician who was blind to the process manually counted the number of hairs in a 1 cm 2 area surrounding each marked spot. Five randomly chosen hairs near the tattooed region will have their thicknesses measured with 3D-Slicer software, and the results will be averaged.
Measured: 3 months
Photographic assessment
A standardized global pretreatment picture of the mid-anterior scalp will be taken using a digital camera in a fixed position, with the use of stereotactic positioning equipment, illumination, and styling. Additionally, close-up pictures of the tattooed areas will be taken at 12cm, 16cm, and 24cm from the glabella. A standardized seven-point rating system was used by two blind investigators to evaluate the photos separately.
Measured: 3 month
Secondary outcomes (1)
Patient satisfaction
On a scale of 1 to 10, where 10 denotes the highest level of satisfaction and 1 denotes the lowest, patients will be assessed how satisfied they are with the effects of their treatment.
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start15 Jun 2025 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion20 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgenetic Alopecia (AGA)Studies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- AGA patients will be randomly allocated in both groups using the envelopes method to reduce the biasness. For 3-months, patients in Group-A will get 2.5mg of minoxidil once daily, while those in Group-B will receive 1mg of minoxidil once daily orally.
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinnah Postgraduate Medical Centre
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hala Batool, Jinnah Postgraduate Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07018349
- Sponsor's protocol ID
- No.F.2-81/2025-GENL/258/JPMC
- Status last verified
- Jun 2025
- First submitted
- 1 Jun 2025
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- 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 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Dose Oral Minoxdil in Androgenic Alopecia
- ClinicalTrials.gov ID
- NCT07018349
- Acronym / sponsor ID
- No.F.2-81/2025-GENL/258/JPMC
- Conditions
- Androgenetic Alopecia (AGA)
- Keywords
- androgenetic alopecia (AGA), Minoxdil, Low oral doses
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Jinnah Postgraduate Medical CentreOther government
- Study start
- 15 Jun 2025 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 20 Oct 2025 (estimated)
- First posted
- 12 Jun 2025 (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.
In order to successfully treat androgenetic alopecia (AGA), this study compares the efficacy of low-dose oral minoxidil dosages of 0.25 mg and 1 mg. It addresses a critical gap in current research, as few studies have examined the relationship between low dosage and outcomes like hair diameter, density, patient satisfaction, and adverse effects, including hypertrichosis. Previous research suggests that low dose of oral minoxidil is a safe and well-tolerated option for hair loss, but the optimal dose for maximizing benefits while minimizing side effects remains unclear. This study aims to determine which dose offers the best balance of efficacy and safety for AGA patients.
Detailed description
The most prevalent kind of progressive hair loss, androgenetic alopecia (AGA), is becoming more prevalent with growing age. AGA can affect a person's quality of life. For men, it shows up as a noticeable receding frontal hairline, whereas for women, it shows up as overall hair loss with frontal hairline retention. The primary causes of the condition are 5-alpha-reductase and dihydrotestosterone (DHT), which shorten anagen cycles and decrease hair follicles. It is still unclear whether precise processes underlie AGA start and vulnerability. AGA is thought to be a polygenic disorder whose onset and progression are influenced by the interplay of environmental, endocrine, and genetic variables. Several studies have shown that AGA negatively impacts on the quality of life (QoL) and self-esteem of the patients. However, because patients' expectations of treatment outcomes are typically higher than reality, AGA has continued to be a therapeutic problem for dermatologists.
FDA-approved treatment managements for AGA at present include oral finasteride, topical minoxidil 2%-5%, and low-level light therapy. The most often recommended drug among them is topical minoxidil solution. The selection of treatments for androgenetic alopecia therapy is still difficult as it requires moral, evidence-based judgment and takes into account the demands, compliance, financial constraints, degree of hair loss, and cosmetic preferences of each patient. Despite the fact that there are several medication, surgery, light-based, and nutraceutical treatment options available to stop or reverse the progression of AGA, selecting the best treatments for this chronic condition can be challenging. This study aims to determine which dose offers the best balance of efficacy and safety for AGA patients.
This study will be an RCT study. All patients will be adequately informed about the treatment regimen, follow-ups, and likely adverse effects before the start of the study. A written consent form will be obtained from each patient.
The study's eligibility for participation will be assessed for patients with AGA with the severity ranging from mild to moderate AGA. All AGA patients will get a trichoscopy and a complete scalp examination on their first appointment in order to rule out other hair-loss conditions, such as other types of alopecia like scarring or inflammatory and alopecia areata. Each patient's AGA stage will then be ascertained using the Savin scale for female patients and the "Norwood Hamilton scale" for male patients. Individuals who meet the clinical and trichoscopic criteria for mild to moderate AGA will be assessed for trial eligibility. Before beginning therapy, testing for hematological disorders, liver, kidney, thyroid, electrolytes, and pregnancy will be conducted. At 3-month follow-up appointment, measurements of body weight and blood pressure will also be taken.
AGA patients will be randomly allocated in both groups using the envelopes method to reduce the biasness. For 3-months, patients in Group-A will get 2.5mg of minoxidil once daily, while those in Group-B will receive 1mg of minoxidil once daily orally. After starting therapy, patients will be asked to come back for evaluations 3 months later. Safety, satisfaction, and the effects of the treatment will be reported. Final outcomes will be evaluated at 3 months post treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- AGA patients will be randomly allocated in both groups using the envelopes method to reduce the biasness. For 3-months, patients in Group-A will get 2.5mg of minoxidil once daily, while those in Group-B will receive 1mg of minoxidil once daily orally.
| Arm | Type | Receives |
|---|---|---|
| Oral Minoxidil 2.5% mg | Experimental | Drug: 2.5% Oral minoxidilGroup-A: 2.5% mg of minoxidil once daily, orally. |
| Oral Minoxidil 1% mg | Experimental | Drug: 1% Oral MinoxidilGroup-B: 1% mg of minoxidil once daily orally. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients have a clinical and trichoscopic diagnosis of mild to severe AGA
Key exclusion criteria (5 listed)
- Patients who, within three months before the trial, had undergone systemic or topical therapies for AGA
- People who suffer from additional hair loss conditions such hyperandrogenism, scarring or inflammatory alopecia, or any hormonal disorders.
- Sensitivity to minoxidil
- Patients with history of severe systemic diseases (heart, renal, or hepatic), a history of hypertension or hypotension, pregnant and breast-feeding women will also be excluded.
- Patient who will not be willing to provide written informed consents.
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 |
|---|---|---|
| 2.5% Oral minoxidilAGA patients will be randomly allocated in both groups using the envelopes method to reduce the biasness. For 3-months, patients in Group-A will get 2.5mg of minoxidil once daily, while those in Group-B will receive 1mg of minoxidil once daily orally. After starting therapy, patients will be asked to come back for evaluations 3 months later. Safety, satisfaction, and the effects of the treatment will be reported. Final outcomes will be evaluated at 3 months post treatment. | Drug | Oral Minoxidil 2.5% mg |
| 1% Oral MinoxidilGroup-B will receive 1mg of minoxidil once daily orally | Drug | Oral Minoxidil 1% mg |
Primary outcome
Hair count and Thickness
Time frame: 3 months
Three distinct areas of the scalp will be marked with jet black Micropigment to guarantee precise measurements. These sites, which will be called the vertex points, mid-frontal, and frontal, respectively, were situated 12, 16, and 24 cm from the glabella. Following the application of just one drop of pigment to the selected area, the ink will be tattooed onto the skin using an insulin needle. The tattooed regions were photographed from a distance using a dermoscopic gadget (FotoFinder System Gmbh) that was linked to a camera (Canon EOS M100 DSLR) and a mobile phone. A trichology-trained technician who was blind to the process manually counted the number of hairs in a 1 cm 2 area surrounding each marked spot. Five randomly chosen hairs near the tattooed region will have their thicknesses measured with 3D-Slicer software, and the results will be averaged.
Photographic assessment
Time frame: 3 month
A standardized global pretreatment picture of the mid-anterior scalp will be taken using a digital camera in a fixed position, with the use of stereotactic positioning equipment, illumination, and styling. Additionally, close-up pictures of the tattooed areas will be taken at 12cm, 16cm, and 24cm from the glabella. A standardized seven-point rating system was used by two blind investigators to evaluate the photos separately.
1 secondary outcome
Patient satisfaction
Time frame: 3 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2.5% Oral minoxidil and 1% Oral Minoxidil in people with Androgenetic Alopecia (AGA), run by Jinnah Postgraduate Medical Centre at 1 site in Pakistan.
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 1 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: opening soon, as of the sponsor's last update on 12 Jun 2025. 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 Pakistan. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hala Batool, MBBS, FCPS Trainee (+92- 334-3414942, soomro7770@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hair count and Thickness (time frame: 3 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?
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 12 Jun 2025.