Phase 3 Study to Evaluate the Efficacy and Safety of Oral Minoxidil (N1087) in Men With Androgenetic Alopecia.
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age18-60
SponsorEurofarma Laboratorios S.A.
About this trial
This study is a Phase 3 clinical trial designed to evaluate the efficacy and safety of N1087 compared with placebo in adult men with androgenetic alopecia (male pattern hair loss).
The study will include male participants aged 18 to 60 years who have a clinical diagnosis of androgenetic alopecia classified as stages 3V, 4, or 5 on the Norwood-Hamilton scale. Participants will be randomly assigned, in a 2:1 ratio, to receive either N1087 or placebo. Neither the participants nor the study team will know which treatment each participant receives.
The study treatment will be taken orally once daily for a total of 24 weeks. During the first 8 weeks, the dose will be gradually increased (titration period) up to a maximum tolerated dose, not exceeding 5 mg. Participants will then continue treatment at the maximum tolerated dose for the remaining 16 weeks.
The main purpose of the study is to assess whether oral minoxidil improves hair growth. The primary outcome measure is the change from baseline in the density of non-vellus hairs in a defined target area of the scalp (vertex) after 24 weeks of treatment, measured using digital phototrichogram analysis.
Secondary objectives include evaluating changes in hair density at earlier time points, hair thickness, the proportion of terminal hairs, clinical improvement assessed by the investigator, quality of life related to hair loss, and participant satisfaction with treatment.
The safety and tolerability of oral minoxidil will also be evaluated by monitoring adverse events, vital signs, and events of special interest throughout the study. An independent Data and Safety Monitoring Committee will oversee participant safety during the trial.
This is a multicenter study conducted in Brazil, with approximately 372 participants expected to be enrolled.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male participants aged 18 to 60 years at the time of signing the informed consent form.
Clinical diagnosis of androgenetic alopecia classified as stages 3V, 4, or 5 according to the Norwood-Hamilton scale, based on the investigator's clinical assessment.
No specific treatment for androgenetic alopecia in the last 6 months, or history of specific treatment for androgenetic alopecia for up to 30 days within the last 6 months.
Willingness to comply with all study procedures and assessments, including permanent scalp tattooing and shaving of the target area.
Disqualifiers
Presence of other causes of alopecia, such as alopecia areata, scarring alopecia, traction alopecia, nutritional deficiency-related alopecia, monilethrix, trichotillomania, trichodystrophy, or chemotherapy-induced alopecia.
History of telogen effluvium within the last 6 months.
Presence of other dermatological conditions affecting the scalp, such as seborrheic dermatitis, psoriasis, eczema, or fungal infections.
Clinically relevant uncontrolled endocrine disorders that may affect the hair cycle.
Trial design
Design model
Parallel
Treatments tested in this trial
Minoxidil oral solution
DrugMinoxidil 5 mg/mL oral solution administered once daily. Treatment includes a dose titration period starting at 0.75 mg and gradually increasing to 1.25 mg, 2.5 mg, and up to a maximum dose of 5 mg or the maximum tolerated dose. The titration period lasts 8 weeks, followed by maintenance at the maximum tolerated dose through Week 24.
Placebo oral solution
DrugPlacebo oral solution drops administered once daily. The placebo follows the same dose titration schedule and treatment duration as the experimental intervention, for a total treatment duration of 24 weeks.
Treatment groups
372 Participants
are divided into 2 treatment groupsGroup A: N1087Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from baseline in non-vellus hair density in the target area of the scalp (vertex)
Change from baseline in the density of non-vellus hairs (≥ 0.03 mm in diameter) in the target area of the scalp (vertex) after 24 weeks of treatment, expressed as hairs per square centimeter (hairs/cm²). Hair density is assessed using digital phototrichogram analysis.
Time frame
Baseline to Week 24Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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