To Evaluate Efficacy, Safety, and Tolerability of KX-826 in Male Subjects With Androgenetic Alopecia

Completed · Phase 2 · Has a placebo group

Conditions studied: Alopecia, Male Pattern Hair Loss

In brief

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.

Key facts

Study ID: NCT05218642
Run by: Suzhou Kintor Pharmaceutical Inc,
People needed: 123
Starts: 2022-01-31
Expected to finish: 2023-02-13
Last updated by the study team: 2023-11-22

Who can join

Age: 18 and older, up to 70. Sex: male. Healthy volunteers: accepted.

You may qualify if…

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
≤150 mmHg, diastolic blood pressure ≥50 and ≤95 mmHg and pulse rate
≥45 and ≤100 bpm; one repeat of results is allowed to evaluate out of range values);
Negative COVID-19 results within 3 days prior first dosing

You may not qualify if…

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:
Affect the safety of the subject throughout the study
Influence the findings of the studies or their interpretations
Impede the subject's ability to complete the entire duration of study
Subject is currently enrolled in an investigational drug or device study;
Subject has used an investigational drug or investigational device treatment within 30 days prior to randomization;
Subject is unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function;
Subject may be unreliable for the study including subjects who engage in excessive alcohol intake or drug abuse (defined as any illicit drug use), or subjects who are unable to return for scheduled follow-up visits;
Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody;
Subject has a known hypersensitivity or previous allergic reaction to any of the active or inactive ingredients in the investigational drug or tattoo ink.
Subject has used any of the following topical preparations or procedures on the scalp:
Topical scalp treatments for hair growth including minoxidil, hormone therapy, anti-androgens, or other agents that are known to affect hair growth within 12 weeks of randomization;
Use of hair regrowth products, including minoxidil, for >4 continuous weeks within 6 months before randomization;
Medical shampoos or solutions which include Ketoconazole or the like (e.g. Terzolin) within four weeks prior to randomization;
Topical scalp over-the-counter (OTC) or cosmetic treatments known or reasonably believed to affect hair growth (e.g., brands such as Aminexil, Maxilene, Nioxin, Foltene, etc.) or hair health or hair growth products with saw palmetto, copper, etc. within four weeks of randomization;
Topical scalp treatments that may have ancillary effect on hair growth including, but not limited to, corticosteroids, pimecrolimus, tacrolimus, and retinoids within four weeks of randomization;
Scalp procedures (surgical, laser, light, or energy treatments, microneedling, etc.) within six months of randomization;
Platelet rich plasma (PRP) procedure on the scalp at any time point.
Subject has used the following systemic medications or procedures:

Where it is running

First OC Dermatology — Fountain Valley, California, United States
Qway Research LLC — Hialeah, Florida, United States
Evoution Clinical Trials — Hialeah Gardens, Florida, United States
Anchor Medical Research, LLC — Miami, Florida, United States
Innovation Medical Group, LLC — Palmetto Bay, Florida, United States
Palm Beach Research Center — West Palm Beach, Florida, United States
DelRicht Research — Baton Rouge, Louisiana, United States
ALLCUTIS Research, LLC — Beverly, Massachusetts, United States
ALLCUTIS Research, LLC — Portsmouth, New Hampshire, United States
Clinical Trials of Texas, LLC — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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