Evaluation of Efficacy and Safety of Oral Minoxidil 1 mg in Female Androgenetic Alopecia
brief 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.
detailed description
This is a phase III, multi center, randomized, double blind, placebo and active controlled parallel group design clinical trial to evaluate the efficacy and safety of oral minoxidil 1 mg for the treatment of AGA in female\* patients aged 18 years or older, with general good health (i.e., with no history of cardiovascular disorders, or any other clinically significant disease) and without any dermatological disorders (e.g., of the scalp in the target region at Visit 1/Screening with the possibility of interfering with the application of the IPs or examination method).
Patients must show and have a history of hair density reduction in the centroparietal area of the scalp, as classified by the Sinclair Scale (Sinclair Scale 2-4).
It is planned that approximately 520 adult female patients with FAGA from 20 trial centers across 4 countries (Germany, Spain, Italy, and Portugal) will enter the clinical trial.
Eligible patients will be randomly assigned in a ratio 2:2:1 (active: control: placebo) to one of the following 3 treatment groups:
1. Active group: oral minoxidil 1 mg (1 tablet, once daily \[OD\]) + topical vehicle solution (1 ml, twice daily \[BID\]) 2. Control group: oral placebo (1 tablet, OD) + topical 2% minoxidil solution (1 ml, BID) 3. Placebo group: oral placebo (1 tablet, OD) + topical vehicle solution (1 ml, BID)
At Visit 2/Baseline, patients will receive three boxes containing 5 blister packs of 10 tablets each (a total of 50 tablets) and 4 bottles of IP solution containing 60 ml of 2% minoxidil solution each to cover 12 weeks (±7 days) of clinical trial treatment. The patients will be instructed how to apply the IPs. The first topical IP treatment will be performed under supervision at the clinical trial center, and then treatments will be performed by the patients at home (also the intake of the first tablet), as follows: Patients will administer the assigned IPs daily for 6 months-one tablet orally OD (in the evening/at night \[preferably before going to bed to minimize anti hypertensive side effects\]) and 2 ml assigned solution topically to the scalp BID (two topical applications of 1 ml each, to be performed at least 8 hours apart). Each patient will be requested to record date and time of treatments in an electronic patient dosing diary (hereinafter called "electronic diary \[e-diary\]"). At the next planned clinical trial center visit (Visit 4/Week 12), the patients will receive a new batch of clinical trial treatment for the next 12 weeks.
The clinical trial consists of a screening period (up to approximately 8 weeks, Week 8 to Day -2), a 6 month treatment period (Week 0 to 24), and a 4 week follow up period (Week 25 to 28).
official title
International Phase III, Multi Center, Randomized, Double Blind, Placebo and Active Controlled and Parallel Group Clinical Trial to Evaluate the Efficacy and Safety of Oral Minoxidil 1 mg in Female Patients With Androgenetic Alopecia