This is a Phase 3, prospective, randomized, double-blind, placebo-controlled, parallel-group, multicenter clinical trial designed to evaluate the efficacy and safety of N1087 in women with female pattern hair loss (FPHL). Participants will receive either N1087 or placebo for 24 weeks. The study includes a titration period starting at 0.5 mg and increasing up to 2 mg daily, followed by treatment at the maximum tolerated dose. The primary objective is to assess changes in non-vellus hair density in the target scalp area after 24 weeks. Secondary objectives include changes in terminal hair density, hair thickness, global photographic assessment, quality of life, and participant satisfaction. Safety will be monitored through adverse events, vital signs, and laboratory tests. Approximately 372 participants will be randomized in a 2:1 ratio (N1087 vs. placebo) across about 10 research centers in Brazil.
This Phase 3 clinical trial is a prospective, randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy and safety of N1087 in women with female pattern hair loss (FPHL), also known as female androgenetic alopecia. FPHL is a chronic, progressive condition characterized by gradual thinning of hair and reduced density, primarily in the frontal and vertex regions of the scalp. Current treatment options are limited, and topical minoxidil, although widely used, is not approved for women in Brazil and presents adherence challenges. Low-dose oral minoxidil has shown promising efficacy and safety in clinical practice and literature, but high-quality controlled trials are lacking. Participants will be randomized in a 2:1 ratio to receive N1087 or placebo for 24 weeks. The intervention begins with an 8-week titration period (0.5 mg/day for 2 weeks, then 1 mg, 1.5 mg, and 2 mg every 2 weeks) followed by 16 weeks at the maximum tolerated dose (up to 2 mg/day). The primary endpoint is the change from baseline in non-vellus hair density (≥0.03 mm diameter) in the target area at Week 24, assessed by standardized digital phototrichogram. Secondary endpoints include changes in terminal hair density, total hair density, hair shaft thickness, reversal of follicular miniaturization, global photographic assessment (Investigator Global Assessment), quality of life (WAA-QoL questionnaire), and participant satisfaction. Safety assessments include adverse events, vital signs, ECG, and laboratory tests. The study will enroll approximately 372 participants across 10 sites in Brazil, with eligibility criteria including women aged 18-60 years, Sinclair scale 2-4, and no recent treatments for FPHL. Exclusion criteria include other causes of alopecia, uncontrolled hypertension, cardiovascular conditions, hormonal disorders, and pregnancy. The total study duration per participant is approximately 36 weeks (up to 12 weeks screening/washout, 8 weeks titration, 16 weeks treatment). A Data Monitoring Committee will oversee safety.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
372
N1087 is an oral solution administered in drops. Treatment begins with an 8-week titration period: 0.5 mg/day for 2 weeks, then 1 mg/day, 1.5 mg/day, and up to 2 mg/day every 2 weeks. After titration, participants continue for 16 weeks at the maximum tolerated dose (up to 2 mg/day). Administered orally once daily for a total of 24 weeks.
Placebo administered once daily for 24 weeks, following the same titration schedule as the experimental arm to maintain blinding.
Change from baseline in non-vellus hair density (≥0.03 mm diameter) in the target scalp area at Week 24
Non-vellus hair density (≥0.03 mm diameter) will be measured in the target scalp area using standardized digital phototrichogram. The primary endpoint is the absolute change from baseline to Week 24.
Time frame: 24 weeks
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