Efficacy and safety of oral minoxidil in women with hormone-imbalanced hair loss

Phase 1

Conditions: Female androgenetic alopecia
MedDRA version: 21.1Level: PTClassification code: 10068168Term: Androgenetic alopecia Class: 100000004858
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Therapeutic area: Diseases [C] - Hormonal diseases [C19]

Registration Number: CTIS2023-503383-17-01

Lead Sponsor: Industrial Farmaceutica Cantabria S.A.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 440

Inclusion Criteria

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) (26) 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, Negative serum pregnancy test at Visit 1/Screening and negative urine pregnancy test at Visit 2/Baseline for WOCBP, WOCBP[1] must either be permanently sterile[1] or agree to use a highly effective birth control method (failure rate ?1% per year when used consistently and correctly)[2] throughout the clinical trial and for at least 2 weeks after last administration of IPs. Gestagens with antiandrogen properties (e.g., cyproterone acetate, dienogest) are allowed if treatment is stable since the last 6 months prior to Visit 2/Baseline and if used as contraceptive and planned to be continued throughout the clinical trial duration. For footnotes ([1] and [2]) please refer to the CTP., Patients willing to maintain the same hairstyle (color and hair regimen) throughout the clinical trial. Hair length must remain of sufficient length to not affect determination of hair density and patient should discuss with clinical trial personnel before changing from Visit 2/Baseline, Patient is willing to maintain the same depilatory habits and intervals regarding facial or body hair before each visit throughout duration of the clinical trial, Patient is willing and able to comply with scheduled visits, treatment plan, laboratory tests and other clinical trial procedures, including daily e diary recordings by the patient using an own electronic device (e.g., tablet, smartphone, personal computer) and an internet connection during the clinical trial

Exclusion Criteria

Known hypersensitivity or known allergy to minoxidil or to any of the other components of the products, Patients who had hair transplant surgery at any time, Patients who had hair weaving, or any other hair extension methods within the last 6 months prior to Visit 2/Baseline, Patients with concurrent use of any occlusive bandages on the treatment area, Clinically significant abnormal laboratory values or ECG findings (if applicable) at Visit 1/Screening indicative of physical illness, according to investigator assessment, Creatinine above upper limit of normal or eGFR < 60 mL/min/1.73 m², calculated by the Modification of Diet in Renal Disease (MDRD) equation, or abnormal albumin-creatinine ratio at Visit 1/Screening, Relevant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, hematological, endocrine, or neurological diseases that in the opinion of the investigator may interfere with the aim of the clinical trial, Presence or history of either untreated or treated latent or active Mycobacterium tuberculosis TBC infection according to patient information, Manifest hypothyroidism at Visit 1/Screening (TSH above upper limit normal and T4 below lower limit normal), Patient has used any of the following topical preparations or procedures on the scalp: a.Any topical scalp treatment at Visit 1/Screening and Visit 2/Baseline. b. Topical scalp treatments for hair growth, including minoxidil within the last 6 months prior to Visit 2/Baseline; or hormone therapy, antiandrogens, or other agents that are known to affect hair growth within 12 weeks prior to Visit 2/Baseline. c.Topical scalp treatments that might have had ancillary effect on hair growth including, but not limited to, corticosteroids, pimecrolimus, and tacrolimus within the last 4 weeks prior to Visit 2/Baseline. d.Topical scalp over the counter (OTC) or cosmetic treatments known or reasonably believed to affect hair growth (e.g., brands such as Maxilene®, Nioxin®, Foltene®, etc.) or hair health or hair growth products with saw palmetto, copper, etc. within the last 4 weeks prior to Visit 2/Baseline. e.Light or laser treatment or microneedling of scalp within the last 6 months prior to Visit 2/Baseline. f. Platelet rich plasma (PRP) procedure on the scalp within the last 6 months prior to Visit 2/Baseline, Patient has used the following systemic medications or procedures: a.Zidovudine, cyclosporine, diazoxide, phenytoin, systemic interferon, psoralens, streptomycin, penicillamine, benoxaprofen, tamoxifen, phenothiazines, or other vasodilators or antihypertensive agents such as guanethidine and derivatives within the last 12 months prior to Visit 2/Baseline. b.Any 5 alpha reductase medications (i.e., dutasteride, finasteride [Propecia®, etc.] or similar product[s]) within the last 12 months prior to Visit 2/Baseline. c.Retinoid therapy within the last 6 months prior to Visit 2/Baseline. d.Beta blockers, anabolic steroids, or corticosteroids (including intramuscular and intralesional injections) within 12 weeks of Visit 2/Baseline. Inhaled, intranasal, or ocular corticosteroids are allowed if use is stable (defined as doses and frequency unchanged for at least 4 weeks prior to Visit 2/Baseline. e.Drugs with antiandrogenic properties, such as flutamide, cimetidine, or ketoconazole within the last 6 months prior to Visit 2/Baseline; bicalutamide within 2 months and spironolactone within 1 month prior to Visit 2/Baseline. Gestagens with antiandrogen p