Evaluation of Oral Minoxidil 1 mg Efficacy and Safety in Female Androgenetic Alopecia: A Phase III Randomized, Double-Blind, Placebo-Controlled Trial

The primary objective of this clinical trial is to evaluate the **efficacy** of oral minoxidil 1 mg in female patients with **androgenetic alopecia**. Specifically, the study aims to demonstrate that the active treatment group, receiving oral minoxidil 1 mg once daily in combination with a topical vehicle solution, is non-inferior to the control group, which receives an oral placebo and a topical 2% minoxidil solution, in terms of changes in Target Area non-vellus Hair Counts (TAHC) from baseline to week 24. Additionally, the trial seeks to establish the superiority of the active treatment group over a placebo group, which receives an oral placebo and a topical vehicle solution, in the same efficacy measure over the same period. This is clinically relevant as it addresses the need for effective treatment options for female androgenetic alopecia, a common cause of hair loss in women.

The secondary objective is to support the safety profile of oral minoxidil 1 mg administered once daily. This aspect of the study is crucial for ensuring that the treatment is not only effective but also safe for long-term use in the target population.

The clinical trial focuses on **female androgenetic alopecia** and involves a study population exclusively composed of female participants. The age range of the participants is 18 years and older, and they are required to be in general good health, with no history of cardiovascular disorders or any other clinically significant diseases. The total number of participants is not provided by the sponsor. Participants were selected based on a diagnosis of female androgenetic alopecia, characterized by a discernible decrease in hair density in the centroparietal area of the scalp. Lifestyle considerations include maintaining the same hairstyle and depilatory habits throughout the trial. Participants must also comply with scheduled visits, treatment plans, laboratory tests, and other clinical trial procedures, including daily electronic diary recordings. The trial population does not include male subjects and is considered a vulnerable population. Key inclusion criteria include a negative pregnancy test for women of childbearing potential and the use of a highly effective birth control method throughout the trial.

The clinical trial is designed as an international, Phase III, multi-center, randomized, double-blind, placebo and active-controlled, parallel group study. The primary objective is to evaluate the efficacy and safety of oral **minoxidil** 1 mg in female patients with **androgenetic alopecia**. The trial will compare the active treatment group, receiving oral minoxidil 1 mg and a topical vehicle solution, against a control group receiving an oral placebo and a topical 2% minoxidil solution. The study aims to demonstrate that the active treatment is non-inferior to the control in terms of change in Target Area non-vellus Hair Counts (TAHC) from baseline to week 24, and to establish the superiority of the active treatment over the placebo group.

The trial is expected to last approximately 12 months, with participant involvement spanning 28 weeks. The sequence of study visits includes an initial screening visit to confirm eligibility, followed by a baseline visit where treatment begins. Subsequent follow-up visits are scheduled at weeks 12, 24, and 28, with the end-of-study visit occurring at week 28. These visits are designed to monitor efficacy and safety endpoints, including changes in TAHC, Target Area non-vellus Hair Width (TAHW), and Target Area non-vellus Hair Density (TAHD), as well as safety laboratory parameters, vital signs, and adverse events.

Participants are expected to maintain consistent hair and depilatory habits throughout the trial and must comply with scheduled visits, treatment plans, and other procedures, including daily electronic diary recordings. Conditions that may lead to early termination from the study include non-compliance with the protocol, withdrawal of consent, or the occurrence of significant adverse events. The trial is set to begin recruitment in February 2024, with an estimated end date in February 2025.

The clinical trial involves the administration of **Minoxidil 1 mg tablet** as the experimental medication. This pharmaceutical form is a tablet, and the active substance is **minoxidil**, a chemical compound. The dosage is set at 1 mg per tablet, with a maximum daily dose of 1 mg. The route of administration is oral, and the frequency is once daily (OD). The maximum treatment period is six months. Participant compliance will be monitored through regular assessments and adherence checks.

In addition to the experimental treatment, the study includes a **placebo** to Minoxidil 1 mg tablet. This placebo is administered in the same pharmaceutical form as the experimental medication, which is a tablet. The placebo is given orally once daily (OD) to maintain the blinding of the study. The placebo serves as a control to evaluate the efficacy and safety of the experimental treatment.

The trial also involves the use of **Regaxidil 20 mg/ml cutaneous solution** as a comparator treatment. This solution contains **minoxidil** as the active substance and is applied topically. The dosage is 1 ml of the solution, with a maximum daily dose of 40 mg. The solution is applied twice daily (BID) for a maximum treatment period of six months. Compliance with the topical application will be monitored through participant diaries and regular site visits.

A **placebo** to Regaxidil 20 mg/ml solution is also utilized in the study. This placebo is administered in the same form as the comparator treatment, which is a cutaneous solution. The placebo is applied topically twice daily (BID) to ensure the study's double-blind design. The placebo helps to assess the superiority of the experimental treatment over the placebo group.

Efficacy in this clinical trial will be assessed primarily through the change in Target Area non-vellus Hair Counts (TAHC) from Baseline to Week 24 (6 months). This primary endpoint will determine the effectiveness of the active treatment group, which includes oral **minoxidil** 1 mg and a topical vehicle solution, compared to the control treatment group, which consists of an oral placebo and a topical 2% minoxidil solution. The trial aims to demonstrate that the active treatment is non-inferior to the control treatment in terms of TAHC changes.

Secondary efficacy endpoints will include changes from Baseline in TAHC at Week 12, as well as changes in Target Area non-vellus Hair Width (TAHW) and Target Area non-vellus Hair Density (TAHD) at Weeks 12 and 24. Additional secondary endpoints involve the Investigator's Global Assessment (IGA) and the Women’s Androgenetic Alopecia Quality of Life (WAA-QoL) at Weeks 12 and 24. These assessments will provide a comprehensive evaluation of the treatment's impact on hair growth and patient quality of life.

The efficacy parameters will be measured and collected at specified timepoints, including Baseline, Week 12, and Week 24. The analysis will utilize validated scales and methodologies to ensure accurate and reliable data collection. The trial is designed to provide robust evidence on the efficacy of oral minoxidil as a treatment for androgenetic alopecia in female patients, offering an alternative to the topical application of minoxidil.