Evaluation of Efficacy and Safety of Oral Minoxidil 1 mg in Female Androgenetic Alopecia
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorIndustrial Farmacéutica Cantabria, S.A.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Diagnosed with FAGA, based on a discernible decrease in hair density (Sinclair Scale 2-4) in the centroparietal area of the scalp.
Hair color of patient provides sufficient contrast with the scalp and as confirmed by TrichoLab Virtual Tattoo® technology at Screening/Visit 1.
A personally signed and dated informed consent document indicating that the patient, has been informed of all pertinent aspects of the clinical trial.
Disqualifiers
Known hypersensitivity or known allergy to minoxidil or to any of the other components of the products.
Pregnancy or pregnancy desire during the clinical trial.
Breastfeeding/Nursing women.
Any diagnosed treated or untreated hypertension (or blood pressure values >150 mmHg systolic / >95 mmHg diastolic) as determined at Visit 1/Screening, and/or history/signs of known cardiovascular diseases (including but not limited to cardiac ischemia, congestive heart failure, cardiac arrhythmia), and patients with pathologies or punctual situations that might either be caused by or increase the risk of cardiac disorders.
Trial design
Design model
Parallel
Treatments tested in this trial
Minoxidil Tablets
DrugThe 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.
Minoxidil Topical
DrugThe 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.
Placebo oral tablet
DrugThe 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.
Vehicle solution
DrugThe 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.
Treatment groups
520 Participants
are divided into 3 treatment groupsGroup A: Active groupExperimental treatment 2 interventions
Group B: Control groupActive comparator 2 interventions
Group C: Placebo groupPlacebo comparator 2 interventions
Trial outcomes
Primary outcomes
1
Change in Target Area non vellus Hair Counts (TAHC)
This is the change in TAHC from Baseline to Week 24 (6 months). A descriptive analysis of the TAHC score at Baseline and Week 24 will be performed by treatment group (active, control and placebo). Also, a descriptive analysis of the change from Baseline to Week 24 (Week 24 - Baseline) will be performed by treatment group (active, control and placebo).
Time frame
From baseline to week 24Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Industrial Farmacéutica Cantabria, S.A.
Lead sponsor
Bioskin GmbH
Collaborator
Astrum CRO, S.L.
Collaborator
Source ClinicalTrials.gov