To Evaluate Efficacy, Safety, and Tolerability of KX-826 in Male Subjects With Androgenetic Alopecia (NCT05218642) | Clinical Trial Compass
CompletedPhase 2
To Evaluate Efficacy, Safety, and Tolerability of KX-826 in Male Subjects With Androgenetic Alopecia
United States123 participantsStarted 2022-01-31
Plain-language summary
The study is a randomized, double-blind, placebo-controlled, parallel group, phase 2 study to evaluate the efficacy, safety and tolerability of KX-826 in male subjects with androgenetic alopecia.
Who can participate
Age range18 Years – 70 Years
SexMALE
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Inclusion criteria
✓. Subject is capable of giving informed consent and complying with study procedures;
✓. Subject is male between the ages of 18 and 70 years, inclusive;
✓. Subject has a clinical diagnosis of mild to moderate androgenetic alopecia; rating IIIv, IV and V on the Norwood Hamilton Scale, with a history of ongoing hair loss;
✓. Subject is willing to maintain the same hairstyle, hair length, and hair color throughout the study
✓. Subject agrees to continue his other general hair care products and regimen for the entire study;
✓. Subject is considered healthy by the Principal Investigator, based on a detailed medical history, full physical examination, clinical laboratory tests, 12-lead ECG and vital signs (systolic blood pressure ≥90 and
✓. Negative COVID-19 results within 3 days prior first dosing
Exclusion criteria
✕. Subject has any dermatological disorders of the scalp in the target region with the possibility of interfering with the application of the investigational drug, such as fungal or bacterial infections, seborrheic dermatitis, psoriasis, eczema, folliculitis, scars, or scalp atrophy;
✕. Subject has any skin pathology or condition that, in the investigator's opinion, could interfere with the evaluation of the investigational drug or requires use of interfering topical, systemic (e.g., uncontrolled thyroid disease, certain genetic disorders that involve hair growth or patterns), or surgical therapy;
. Subject has current or recent history (within 12 months) of hair weaves, non-breathable wigs, or hair bonding;
✕. Subject had scalp hair transplants at any time
✕. Subject has a history or active hair loss due to diffuse telogen effluvium, alopecia areata, scarring alopecia, trichotillomania, or conditions/ diseases other than AGA;
✕. Subject has a current or recent history (within six months) of severe dietary or weight changes or has a history of eating disorder(s); if such has resulted in hair loss;
✕. Any disorder, including but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator and could:
✕. Subject is currently enrolled in an investigational drug or device study;