Androgenic AlopeciaPhase 3minaNCT07273799
Comparison of Outcomes Between Topical Minoxidil Versus Oral Minoxidil for the Treatment of Androgenetic Alopecia
A Phase 3 study testing Minoxidil 5 % Topical Spray and minoxidil in people with Androgenic Alopecia, run by Sheikh Zayed Federal Postgraduate Medical Institute.
Trial summary
To compare the outcome of topical minoxidil 5% spray versus oral minoxidil 2.5 mg tablet for the treatment of androgenetic alopecia in males and females. Outcomes include efficacy of the treatment, measured by reduction in hair shedding, improvement in hair density and new hair growth as assessed by physican and… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Androgenic Alopecia
- What is being tested?
- Minoxidil 5 % Topical Spray and minoxidil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 20 Dec 2025to 1 Jun 2026
- Phase
- Phase 3
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with androgenic alopecia Norwood-Hamilton class 2-6 in males and Sinclair class 2-5 in females
- History of androgentic alopecia for at least 1 year
- 18 to 50 years of age
- Willing to provide informed consent
- Willing to not use any other hair loss treatment during the treatment period
Who cannot join
- History of cardiovascular disease
- Use of some other hair restoration therapy in the past 6 months such as minoxidil, finasteride or PRP
- Presence of other causes of alopecia (e.g., alopecia areata, scarring alopecia).
- Pregnant and lactating females
- Previous Hair Transplantation
- Patients with a known hypersensitivity to the study drug or class of study drug
- Patients with co-morbid conditions like chronic liver disease, chronic kidney disease, neurological or psychiatric disorders
- Presence of any other autoimmune disease (especially thyroid disease)
About this study
To compare the outcome of topical minoxidil 5% spray versus oral minoxidil 2.5 mg tablet for the treatment of androgenetic alopecia in males and females. Outcomes include efficacy of the treatment, measured by reduction in hair shedding, improvement in hair density and new hair growth as assessed by physican and patient assessment as well as safety, defined as incidence and severity of adverse events over a treatment period of 6 months
Read the detailed description
This cohort, adaptive, randomized, double armed group, controlled, investigator-initiated interventional study is designed to demonstrate the superiority of a combination of Topical minoxidil vs oral minoxidil in patients suffering from androgenetic alopecia who consent to randomization following a new diagnosis in Pakistan.
Conditions Androgenetic Alopecia
Intervention/Treatment:
Drug: Oral Minoxidil Drug: Topical Minoxidil
- Conditions
- Androgenic Alopecia
- Being tested
- Minoxidil 5 % Topical Spray, minoxidil, Placebo Spray, Placebo Tablet or Capsule
- Keywords
- Androgenic Alopecia, Minoxidil
- 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 SprayDrug
Topical spray on hairs
minoxidilDrug
Oral minoxidil 2.5mg
Placebo SprayDrug
placebo spray
Placebo Tablet or CapsuleDrug
Placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| Disease Control | Placebo comparator | Placebo spray and palcebo tablet Receives: Drug: Placebo Spray; Drug: Placebo Tablet or Capsule |
| Minoxidil Spray Arm | Active comparator | Placebo tablet Mixidil spray Receives: Drug: Minoxidil 5 % Topical Spray; Drug: Placebo Tablet or Capsule |
| Minoxidil Tablet Arm | Active comparator | Mixidil tablet placebo spray Receives: Drug: minoxidil; Drug: Placebo Spray |
| Minoxidil Tablet + Spray Arm | Experimental | Minoxidil spray Minoxidil Tablet Receives: Drug: Minoxidil 5 % Topical Spray; Drug: minoxidil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of drug
The effectiveness of the treatment in terms of reduction in hair shedding, improvement in hair density, and new hair growth will be measured by a standardised seven point scale for physician photographic assessment and patient self assessment.
Measured: 6 months
Physician Photographic Assessment Scale
(+3 = Excellent Improvement, +2 = moderately improvement , +1 = mild improvement, 0 = no change, -1 = mild worsening, -2 =moderate worsening, -3 = severe worsening)
Measured: 6 months
Patient Satisfaction Scale
-3 Very Unsatisfied, -2 Moderately Unsatisfied, -1 Slightly Unsatisfied, 0 No Change, 1 Slightly Satisfied, 2 Moderately Satisfied, 3 Very Satisfied
Measured: 6 months
Secondary outcomes (2)
Drug Safety
It is defined as the incidence and severity of adverse events associated with oral and topical minoxidil over the treatment period. This includes localised adverse effects, such as eczema, scalp irritation, light headedness, headache or hypertrichosis, and systemic adverse effects, such as tachycardia, fluid retention and allergic reactions. All information will be recorded in a predesigned proforma.
Measured: 6 months
Severity of adverse effect (mild, moderate, severe)
Each adverse effect will be categorized as Mild, Moderate and Severe:
Mild: No interference with daily activities; may include mild scalp itching or irritation Moderate: Requires intervention (e.g., symptomatic treatment) but allows continuation of minoxidil. Severe: Interferes significantly with daily activities or presents a risk to the patient's health, potentially requiring cessation of treatment (e.g. persistent tachycardia or severe allergic reaction).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start20 Dec 2025 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgenic AlopeciaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheikh Zayed Federal Postgraduate Medical Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sohaib Ashraf, Sheikh Zayed Federal Postgraduate Medical Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07273799
- Sponsor's protocol ID
- 02-TERC/NHRC-SZH/Int-SC/651
- Acronym
- mina
- Status last verified
- Nov 2025
- First submitted
- 16 Nov 2025
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Outcomes Between Topical Minoxidil Versus Oral Minoxidil for the Treatment of Androgenetic Alopecia
- ClinicalTrials.gov ID
- NCT07273799
- Acronym / sponsor ID
- mina / 02-TERC/NHRC-SZH/Int-SC/651
- Conditions
- Androgenic Alopecia
- Keywords
- Androgenic Alopecia, Minoxidil
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sheikh Zayed Federal Postgraduate Medical InstituteUniversity, hospital or other
- Study start
- 20 Dec 2025 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 10 Dec 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.
To compare the outcome of topical minoxidil 5% spray versus oral minoxidil 2.5 mg tablet for the treatment of androgenetic alopecia in males and females. Outcomes include efficacy of the treatment, measured by reduction in hair shedding, improvement in hair density and new hair growth as assessed by physican and patient assessment as well as safety, defined as incidence and severity of adverse events over a treatment period of 6 months
Detailed description
This cohort, adaptive, randomized, double armed group, controlled, investigator-initiated interventional study is designed to demonstrate the superiority of a combination of Topical minoxidil vs oral minoxidil in patients suffering from androgenetic alopecia who consent to randomization following a new diagnosis in Pakistan.
Conditions Androgenetic Alopecia
Intervention/Treatment:
Drug: Oral Minoxidil Drug: Topical Minoxidil
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Disease Control | Placebo comparator | Drug: Placebo Spray, Drug: Placebo Tablet or CapsulePlacebo spray and palcebo tablet |
| Minoxidil Spray Arm | Active comparator | Drug: Minoxidil 5 % Topical Spray, Drug: Placebo Tablet or CapsulePlacebo tablet Mixidil spray |
| Minoxidil Tablet Arm | Active comparator | Drug: minoxidil, Drug: Placebo SprayMixidil tablet placebo spray |
| Minoxidil Tablet + Spray Arm | Experimental | Drug: Minoxidil 5 % Topical Spray, Drug: minoxidilMinoxidil spray Minoxidil Tablet |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients with androgenic alopecia Norwood-Hamilton class 2-6 in males and Sinclair class 2-5 in females
- History of androgentic alopecia for at least 1 year
- 18 to 50 years of age
- Willing to provide informed consent
- Willing to not use any other hair loss treatment during the treatment period
Key exclusion criteria (8 listed)
- History of cardiovascular disease
- Use of some other hair restoration therapy in the past 6 months such as minoxidil, finasteride or PRP
- Presence of other causes of alopecia (e.g., alopecia areata, scarring alopecia).
- Pregnant and lactating females
- Previous Hair Transplantation
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 SprayTopical spray on hairs | Drug | Minoxidil Spray Arm, Minoxidil Tablet + Spray Arm |
| minoxidilOral minoxidil 2.5mg | Drug | Minoxidil Tablet + Spray Arm, Minoxidil Tablet Arm |
| Placebo Sprayplacebo spray | Drug | Disease Control, Minoxidil Tablet Arm |
| Placebo Tablet or CapsulePlacebo tablet | Drug | Disease Control, Minoxidil Spray Arm |
Primary outcome
Efficacy of drug
Time frame: 6 months
The effectiveness of the treatment in terms of reduction in hair shedding, improvement in hair density, and new hair growth will be measured by a standardised seven point scale for physician photographic assessment and patient self assessment.
Physician Photographic Assessment Scale
Time frame: 6 months
(+3 = Excellent Improvement, +2 = moderately improvement , +1 = mild improvement, 0 = no change, -1 = mild worsening, -2 =moderate worsening, -3 = severe worsening)
Patient Satisfaction Scale
Time frame: 6 months
-3 Very Unsatisfied, -2 Moderately Unsatisfied, -1 Slightly Unsatisfied, 0 No Change, 1 Slightly Satisfied, 2 Moderately Satisfied, 3 Very Satisfied
2 secondary outcomes
Drug Safety
Time frame: 6 months
Severity of adverse effect (mild, moderate, severe)
Time frame: 6 months
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 10 Dec 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Minoxidil 5 % Topical Spray and minoxidil in people with Androgenic Alopecia, run by Sheikh Zayed Federal Postgraduate Medical Institute.
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 8 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 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
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?
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?
Efficacy of drug (time frame: 6 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 10 Dec 2025.