Androgenetic AlopeciaPhase 2NCT06826001
Various Procedural Treatment Options for Androgenetic Alopecia
A Phase 2 study testing topical finasteride and Topical minoxidil in people with Androgenetic Alopecia, run by Sheikh Zayed Medical College at 1 site in Pakistan.
Trial summary
Androgenetic alopecia (AGA)is the most common form of alopecia. It predominantly affects males, but there has been a significant surge in female preponderance too, over the last decade Minoxidil belong to the anti-hypertensive class but it also affects the potassium channels present in vascular smooth muscles and hair… Read more about this study
- Who is it for?
- Ages 20 to 50 years, men only
- Conditions the study is for
- Androgenetic Alopecia
- What is being tested?
- topical finasteride and Topical minoxidil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 sitePakistan
- Study dates
- Feb 2025to Jul 2025
- Phase
- Phase 2
- 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 20 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Age: 20-50 years
- Gender: Male
- ANDROGENETIC ALOPECIA with AGA stage 2-6 Norwood-Hamilton -classification
- Patients not taking any treatment in last 1 month
Who cannot join
- Abrasion or abnormalities to the scalp
- Hair transplant
- Hypersensitivity
- Recent history of local infections of the head
- History of relevant significant disease active seborrheic dermatitis
- Concurrent use of :
Show all 9Show fewer
- corticosteroids
- anabolic steroids or over-the-counter 'hair restorers'
- use of drugs with anti-androgenic properties within 6 months light or laser treatment of the scalp within the last 3 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Sheikh zayed Medical College and Hospital, Rahim Yar Khan, Punjab 644200
Rahim Yar Khan, Punjab Province, 644200
Sheikh zayed Medical college rahim yar khan punjab, +92689230168, info@szmc.edu.pk
About this study
Official title: COMPARISON OF EFFICACY OF TOPICAL FINESTERIDE VERSUS TOPICAL MINOXIDAL IN TREATMENT OF ANDROGENETIC ALOPECIA
Androgenetic alopecia (AGA)is the most common form of alopecia. It predominantly affects males, but there has been a significant surge in female preponderance too, over the last decade Minoxidil belong to the anti-hypertensive class but it also affects the potassium channels present in vascular smooth muscles and hair follicles. This potassium channel activity may stimulate the microcirculation around the hair follicles and induces arteriolar vasodilation, thereby encouraging conditions conducive to hair growth Topical administration of finasteride offers the potential to reduce systemic effects related to its mechanism of action by preferentially inhibiting 5-a reductase in the scalp, as has been suggested in recent years so in this study we are going to compare efficacy of topical minoxidil versus topical finasteride in treatment of androgenetic alopecia
Read the detailed description
Androgenetic alopecia (AGA)is considered to be a very common form of alopecia. Minoxidil belong to the anti-hypertensive class but it also affects the potassium channels present in vascular smooth muscles and hair follicles. This potassium channel activity may stimulate the microcirculation around the hair follicles and induces arteriolar vasodilation, thereby encouraging conditions conducive to hair growth The clinical efficacy of oral finasteride for treating AGA is well established. Although oral finasteride is generally well tolerated Topical finasteride is a medication that is used to treat hair loss in men and women. It is a topical version of the oral medication finasteride, which works by blocking the conversion of testosterone to dihydrotestosterone (DHT), a hormone that contributes to hair loss. Topical administration of finasteride offers the potential to reduce systemic effects related to its mechanism of action by preferentially inhibiting 5-a reductase in the scalp, as has been suggested in recent years.
OBJECTIVE "To compare the efficacy of topical finasteride vs topical minoxidil in the treatment of androgenetic alopecia in tertiary care hospital"
DATA COLLECTION:
Data will be collected on prescribed proforma which is attached, at Dermatology OPD, Sheikh Zayed Hospital, Rahim Yar Khan. Patient will be selected on basis of inclusion \& exclusion criteria. Informed consent will be taken from selected patients before data collection. Study will include 190 patients which will be divided into 2 groups A \& B, 95 in each group. Group A will receive topical finasteride spray 0.25% twice daily for 12 weeks. Group B will receive topical 5% minoxidil twice daily for 12 weeks Patient will be followed at the end of 12 weeks therapy.
DATA ANALYSIS:
Data will be analyzed by SPSS (Statistical Package for the Social Sciences) v25.0.
- Conditions
- Androgenetic Alopecia
- Being tested
- topical finasteride, Topical minoxidil
- Keywords
- androgenetic alopecia, finasteride, minoxidil, hairloss
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
topical finasterideDrug
Group A will receive topical finesteride spray 0.25% twice daily for 12 weeks
Topical minoxidilDrug
Group B will receive topical 5% minoxidal twice daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Finesteride group | Active comparator | Group A will receive topical finasteride spray 0.25% twice daily for 12 weeks Receives: Drug: topical finasteride |
| Minoxidil group | Active comparator | Group B will receive topical 5% minoxidil twice daily for 12 weeks Receives: Drug: Topical minoxidil |
What is being measured
The primary outcome is the main question the study is designed to answer.
COMPARISON OF EFFICACY OF TOPICAL FINESTERIDE VERSUS TOPICAL MINOXIDAL IN TREATMENT OF ANDROGENETIC ALOPECIA
The final efficacy will be divided into following groups on the basis of Norwood-Hamilton scale from the baseline :1.Excellent efficacy: It is defined as greater than two scale change in hair density as measured from baseline . 2. moderate efficacy : It is defined as one to two scale change in hair density as measured from baseline. Percentage increase in hair density as clinically measured by the surface area from the baseline. 3.Non efficacious: It is defined as less than one scale change in hair density as measured clinically from baseline.
Measured: Clinical assessment for efficacy will be done monthly for 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study startFeb 2025 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (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.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheikh Zayed Medical College
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Farah Humera, Sheikh Zayed Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06826001
- Sponsor's protocol ID
- sheikh-ZMC-FH
- Status last verified
- Feb 2025
- First submitted
- 21 Jan 2025
- Last updated
- 13 Feb 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 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARISON OF EFFICACY OF TOPICAL FINESTERIDE VERSUS TOPICAL MINOXIDAL IN TREATMENT OF ANDROGENETIC ALOPECIA
- ClinicalTrials.gov ID
- NCT06826001
- Acronym / sponsor ID
- sheikh-ZMC-FH
- Conditions
- Androgenetic Alopecia
- Keywords
- androgenetic alopecia, finasteride, minoxidil, hairloss
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Sheikh Zayed Medical CollegeOther government
- Study start
- Feb 2025 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 13 Feb 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.
Androgenetic alopecia (AGA)is the most common form of alopecia. It predominantly affects males, but there has been a significant surge in female preponderance too, over the last decade Minoxidil belong to the anti-hypertensive class but it also affects the potassium channels present in vascular smooth muscles and hair follicles. This potassium channel activity may stimulate the microcirculation around the hair follicles and induces arteriolar vasodilation, thereby encouraging conditions conducive to hair growth Topical administration of finasteride offers the potential to reduce systemic effects related to its mechanism of action by preferentially inhibiting 5-a reductase in the scalp, as has been suggested in recent years so in this study we are going to compare efficacy of topical minoxidil versus topical finasteride in treatment of androgenetic alopecia
Detailed description
Androgenetic alopecia (AGA)is considered to be a very common form of alopecia. Minoxidil belong to the anti-hypertensive class but it also affects the potassium channels present in vascular smooth muscles and hair follicles. This potassium channel activity may stimulate the microcirculation around the hair follicles and induces arteriolar vasodilation, thereby encouraging conditions conducive to hair growth The clinical efficacy of oral finasteride for treating AGA is well established. Although oral finasteride is generally well tolerated Topical finasteride is a medication that is used to treat hair loss in men and women. It is a topical version of the oral medication finasteride, which works by blocking the conversion of testosterone to dihydrotestosterone (DHT), a hormone that contributes to hair loss. Topical administration of finasteride offers the potential to reduce systemic effects related to its mechanism of action by preferentially inhibiting 5-a reductase in the scalp, as has been suggested in recent years.
OBJECTIVE "To compare the efficacy of topical finasteride vs topical minoxidil in the treatment of androgenetic alopecia in tertiary care hospital"
DATA COLLECTION:
Data will be collected on prescribed proforma which is attached, at Dermatology OPD, Sheikh Zayed Hospital, Rahim Yar Khan. Patient will be selected on basis of inclusion \& exclusion criteria. Informed consent will be taken from selected patients before data collection. Study will include 190 patients which will be divided into 2 groups A \& B, 95 in each group. Group A will receive topical finasteride spray 0.25% twice daily for 12 weeks. Group B will receive topical 5% minoxidil twice daily for 12 weeks Patient will be followed at the end of 12 weeks therapy.
DATA ANALYSIS:
Data will be analyzed by SPSS (Statistical Package for the Social Sciences) v25.0.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Finesteride group | Active comparator | Drug: topical finasterideGroup A will receive topical finasteride spray 0.25% twice daily for 12 weeks |
| Minoxidil group | Active comparator | Drug: Topical minoxidilGroup B will receive topical 5% minoxidil twice daily for 12 weeks |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age: 20-50 years
- Gender: Male
- ANDROGENETIC ALOPECIA with AGA stage 2-6 Norwood-Hamilton -classification
- Patients not taking any treatment in last 1 month
Key exclusion criteria (9 listed)
- Abrasion or abnormalities to the scalp
- Hair transplant
- Hypersensitivity
- Recent history of local infections of the head
- History of relevant significant disease active seborrheic dermatitis
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 |
|---|---|---|
| topical finasterideGroup A will receive topical finesteride spray 0.25% twice daily for 12 weeks | Drug | Finesteride group |
| Topical minoxidilGroup B will receive topical 5% minoxidal twice daily for 12 weeks | Drug | Minoxidil group |
Primary outcome
COMPARISON OF EFFICACY OF TOPICAL FINESTERIDE VERSUS TOPICAL MINOXIDAL IN TREATMENT OF ANDROGENETIC ALOPECIA
Time frame: Clinical assessment for efficacy will be done monthly for 6 months
The final efficacy will be divided into following groups on the basis of Norwood-Hamilton scale from the baseline :1.Excellent efficacy: It is defined as greater than two scale change in hair density as measured from baseline . 2. moderate efficacy : It is defined as one to two scale change in hair density as measured from baseline. Percentage increase in hair density as clinically measured by the surface area from the baseline. 3.Non efficacious: It is defined as less than one scale change in hair density as measured clinically from baseline.
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 13 Feb 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 Phase 2 study testing topical finasteride and Topical minoxidil in people with Androgenetic Alopecia, run by Sheikh Zayed Medical College 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 4 inclusion and 9 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 13 Feb 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.
What does this 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.
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?
Contact Farah Humera, post graduate resident derma (+923328334251, drfarahumera1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COMPARISON OF EFFICACY OF TOPICAL FINESTERIDE VERSUS TOPICAL MINOXIDAL IN TREATMENT OF ANDROGENETIC ALOPECIA (time frame: Clinical assessment for efficacy will be done monthly for 6 months). 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 13 Feb 2025.