Evaluation of Efficacy and Safety of Oral Minoxidil 1 mg in Female Androgenetic Alopecia
- Conditions
- Androgenetic AlopeciaFemale Pattern Baldness
- Registration Number
- NCT05888922
- Lead Sponsor
- Industrial Farmacéutica Cantabria, S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- Female
- Target Recruitment
- 520
Inclusion Criteria:<br><br> 1. Female patients aged 18 years or older, with general good health (i.e., with no<br> history of cardiovascular disorders, or any other clinically significant disease).<br><br> 2. Diagnosed with FAGA, based on a discernible decrease in hair density (Sinclair Scale<br> 2-4) in the centroparietal area of the scalp.<br><br> 3. Hair color of patient provides sufficient contrast with the scalp and as confirmed<br> by TrichoLab Virtual Tattoo® technology at Screening/Visit 1.<br><br> 4. A personally signed and dated informed consent document indicating that the patient,<br> has been informed of all pertinent aspects of the clinical trial.<br><br> 5. Negative serum pregnancy test at Visit 1/Screening and negative urine pregnancy test<br> at Visit 2/Baseline for women of child-bearing potential (WOCBP).<br><br> 6. WOCBP must either be permanently sterile1 or agree to use a highly effective birth<br> control method (failure rate ?1% per year when used consistently and correctly)<br> throughout the clinical trial and for at least 2 weeks after last administration of<br> IPs.<br><br> Gestagens with antiandrogen properties (e.g., cyproterone acetate, dienogest) are<br> allowed if treatment is stable since the last 6 months prior to Visit 2/Baseline and<br> if used as contraceptive and planned to be continued throughout the clinical trial<br> duration.<br><br> 7. Patients willing to maintain the same hairstyle (color and hair regimen) throughout<br> the clinical trial. Hair length must remain of sufficient length to not affect<br> determination of hair density and patient should discuss with clinical trial<br> personnel before changing from Visit 2/Baseline.<br><br> 8. Patient is willing to maintain the same depilatory habits and intervals regarding<br> facial or body hair before each visit throughout duration of the clinical trial.<br><br> 9. Patient is willing and able to comply with scheduled visits, treatment plan,<br> laboratory tests and other clinical trial procedures, including daily e diary<br> recordings by the patient using an own electronic device (e.g., tablet, smartphone,<br> personal computer) and an internet connection during the clinical trial.<br><br>Exclusion Criteria:<br><br> 1. Known hypersensitivity or known allergy to minoxidil or to any of the other<br> components of the products.<br><br> 2. Pregnancy or pregnancy desire during the clinical trial.<br><br> 3. Breastfeeding/Nursing women.<br><br> 4. Any diagnosed treated or untreated hypertension (or blood pressure values >150 mmHg<br> systolic / >95 mmHg diastolic) as determined at Visit 1/Screening, and/or<br> history/signs of known cardiovascular diseases (including but not limited to cardiac<br> ischemia, congestive heart failure, cardiac arrhythmia), and patients with<br> pathologies or punctual situations that might either be caused by or increase the<br> risk of cardiac disorders.<br><br> 5. Patients with any dermatological disorders of the scalp in the target region at<br> Visit 1/Screening with the possibility of interfering with the application of the<br> IPs or examination method, such as<br><br> 1. Active moderate or severe seborrheic dermatitis under chronic treatment,<br> abrasion, actinic keratosis, or inflammatory disorders, or<br><br> 2. any local infection of the skin/subcutaneous tissues of the head within the<br> previous 3 months, or<br><br> 3. any documented history of active atopic dermatitis or psoriasis in the scalp<br> within the previous 6 months.<br><br> 4. any other types of alopecia (e.g., alopecia areata or scarring alopecia) at any<br> time point or diffuse telogen effluvium, trichotillomania, or other<br> pathological hair loss conditions/diseases other than AGA in the last 3 months<br> at the discretion of the investigator).<br><br> 6. Patients who had hair transplant surgery at any time.<br><br> 7. Patients who had hair weaving, or any other hair extension methods within the last 6<br> months prior to Visit 2/Baseline.<br><br> 8. Clinically significant abnormal laboratory values or ECG findings (if applicable) at<br> Visit 1/Screening indicative of physical illness, according to investigator<br> assessment.<br><br> 9. Both creatinine and eGFR above upper limit of normal at Visit 1/Screening.<br><br> 10. Relevant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory,<br> skin, hematological, endocrine, or neurological diseases that in the opinion of the<br> investigator may interfere with the aim of the clinical trial.<br><br> 11. Patient has used any of the following topical preparations or procedures on the<br> scalp:<br><br> 1. Topical scalp treatments for hair growth, including minoxidil within the last 6<br> months prior to Visit 2/Baseline; or hormone therapy, antiandrogens, or other<br> agents that are known to affect hair growth within 12 weeks prior to Visit<br> 2/Baseline.<br><br> 2. Topical scalp treatments that might have had ancillary effect on hair growth<br> including, but not limited to, corticosteroids, pimecrolimus, and tacrolimus<br> within the last 4 weeks prior to Visit 2/Baseline.<br><br> 3. Topical scalp over the counter (OTC) or cosmetic treatments known or reasonably<br> believed to affect hair growth (e.g., brands such as Maxilene®, Nioxin®,<br> Foltene®, etc.) or hair health or hair growth products with saw palmetto,<br> copper, etc. within the last 4 weeks prior to Visit 2/Baseline.<br><br> 4. Light or laser treatment or microneedling of scalp within the last 6 months<br> prior to Visit 2/Baseline.<br><br> 5. Platelet rich plasma (PRP) procedure on the scalp within the last 6 months<br> prior to Visit 2/Baseline.<br><br> 12. Patient has used the following systemic medications or procedures:<br><br> 1. Zidovudine, cyclosporine, diazoxide, phenytoin, systemic interferon, psoralens,<br> streptomycin, penicillamine, benoxaprofen, tamoxifen, phenothiazines, or other<br> vasodilators or antihypertensive agents such as guanethidine and derivatives<br> within the last 12 months prior to Visit 2/Baseline.<br><br> 2. Any 5 alpha reductase medications (i.e., dutasteride, finasteride [Propecia®,<br> etc.] or similar product[s]) within the last 12 months prior to Visit<br> 2/Baseline.<br><br> 3. Retinoid therapy within the last 6 months prior to Visit 2/Baseline.<br><br> 4. Beta blockers, anabolic steroids, or corticosteroids (including intramuscular<br> and intralesional injections) within 12 weeks of Visit 2/Baseline. Inhaled,<br> intranasal, or ocular corticosteroids are allowed if use is stable (defined as<br> doses and frequency unchanged for at least 4 weeks prior to Visit 2/Baseline.<br><br> 5. Drugs with antiandrogenic properties, such as flutamide, cimetidine, or<br> ketoconazole within the last 6 months prior to Visit 2/Baseline; bicalutamide<br> within 2 months and spironolactone within 1 month prior to Visit 2/Baseline.<br> Gestagens with antiandrogen properties (e.g., cyproterone acetate, dienogest)<br> are allowed if treatment is stable since the last 6 months prior to Visit<br> 2/Baseline and if used as contraceptive.<br><br> 6. Minoxidil within the last 6 months prior to Visit 2/Baseline.<br><br> 7. Prostaglandins and derivates within the last 3 months prior to Visit<br> 2/Baseline. Topical and ocular prostaglandins and its derivates a
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in Target Area non vellus Hair Counts (TAHC)
- Secondary Outcome Measures
Name Time Method