Evaluation of Efficacy and Safety of Oral Minoxidil 1 mg in Female Androgenetic Alopecia

Summary

The goal of this clinical trial is to learn about oral minoxidil 1mg in the treatment of women with androgenetic alopecia, a type of hormone-imbalanced hair loss.

The main questions to answer are to know about that minoxidil 1mg is as effective as minoxidil 2% topical solution (comparator product) and is more effective than placebo; and to ensure treatment with oral minoxidil is safe.

Participants will be assigned randomly to receive one of the following treatment combinations:

* the test product (oral minoxidil 1 mg, once/day) and the vehicle solution (vehicle means it looks like the comparator product, but it does not contain an active ingredient, 2 times/day), or
* the placebo tablet (placebo means it looks like the test product, but it does not contain an active ingredient, once/day) and the comparator product (2% minoxidil solution, 2 times/day), or
* the placebo tablet (once/day) and the vehicle solution (2 times/day).

The clinical trial will take up to 36 weeks. During this time, patients will come to the clinical trial centre for 5 times for examinations and will be called by phone twice. At the visits, the following examinations will be performed: photos of the hair will be taken to determine hair density, assessment of changes in scalp hair growth, measurement of blood pressure, pulse, and body temperature, a physical examination, blood withdrawal to determine any abnormalities in the blood, urine sampling and analysis, performance of ECG, and evaluation of hypertrichosis (i.e., excessive hair growth over the body). Furthermore, patients will be asked daily whether they had experienced any side effects or took any new medications (or changed the dose of a known medication) or underwent any medical procedure. Also, women of childbearing potential must undergo pregnancy tests in blood and urine.

Conditions

• Androgenetic Alopecia
• Female Pattern Baldness

Interventions

DRUG

Minoxidil Tablets

The clinical trial will use a block randomization scheme to assign those eligible patients to one of the three arms of the study treatment on a 2:2:1 ratio. All patients will be given a kit with oral tablets (active/placebo) 1 tablet to be taken once a day and a topical solution (active comparator/vehicle) to be applied 1 ml twice daily.

DRUG

Minoxidil Topical

The clinical trial will use a block randomization scheme to assign those eligible patients to one of the three arms of the study treatment on a 2:2:1 ratio. All patients will be given a kit with oral tablets (active/placebo) 1 tablet to be taken once a day and a topical solution (active comparator/vehicle) to be applied 1 ml twice daily.

DRUG

Placebo oral tablet

The clinical trial will use a block randomization scheme to assign those eligible patients to one of the three arms of the study treatment on a 2:2:1 ratio. All patients will be given a kit with oral tablets (active/placebo) 1 tablet to be taken once a day and a topical solution (active comparator/vehicle) to be applied 1 ml twice daily.

DRUG

Vehicle solution

The clinical trial will use a block randomization scheme to assign those eligible patients to one of the three arms of the study treatment on a 2:2:1 ratio. All patients will be given a kit with oral tablets (active/placebo) 1 tablet to be taken once a day and a topical solution (active comparator/vehicle) to be applied 1 ml twice daily.

Sponsors & Collaborators

• Bioskin GmbH

  collaborator INDUSTRY

• Astrum CRO, S.L.

  collaborator UNKNOWN

• Industrial Farmacéutica Cantabria, S.A.

  lead INDUSTRY

Principal Investigators

• Ana López-Ballesteros · Industrial Farmacéutica Cantabria, S.A.

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-10-17

Primary Completion

2026-10-31

Completion

2026-11-30

Countries

• Germany

Study Locations