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To Evaluate Efficacy, Safety, and Tolerability of KX-826 in Male Subjects With Androgenetic Alopecia | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 2 Study in Male Subjects With Androgenetic Alopecia to Evaluate the Efficacy, Safety, and Tolerability of KX-826 Following Topical Multiple Dose Administration

NCT05218642•Suzhou Kintor Pharmaceutical Inc,

View on ClinicalTrials.gov

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.

Detailed Description

KX-826 is a new investigational androgen receptor (AR) antagonist for the treatment of male pattern hair loss (androgenetic alopecia). A total of 120 subjects will be randomized to one of four cohorts: 2.5 mg BID, 5 mg QD, 5mg BID of KX-826 or placebo (BID or QD) for 24 weeks. The primary endpoint of the study is to assess the changes from baseline in non-vellus TAHC （Target Area Hair Counts）at Week 24 in comparison to placebo

Eligibility

Age

18 - 70 years

Sex

MALE

Healthy Volunteers

Yes

Inclusion Criteria

•1. Subject is capable of giving informed consent and complying with study procedures;
•2. Subject is male between the ages of 18 and 70 years, inclusive;
•3. 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;
•4. Subject is willing to maintain the same hairstyle, hair length, and hair color throughout the study
•5. Subject agrees to continue his other general hair care products and regimen for the entire study;
•6. 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);
•7. Negative COVID-19 results within 3 days prior first dosing

Exclusion Criteria

•1. 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;
•2. 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;
•3. Subject has current or recent history (within 12 months) of hair weaves, non-breathable wigs, or hair bonding;
•4. Subject had scalp hair transplants at any time
•5. Subject has a history or active hair loss due to diffuse telogen effluvium, alopecia areata, scarring alopecia, trichotillomania, or conditions/ diseases other than AGA;
•6. 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;
•7. 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
+25 more criteria

Locations (10)

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

Key Dates

Start Date

January 31, 2022

Primary Completion Date

February 13, 2023

Completion Date

February 13, 2023

Last Updated

November 22, 2023

Enrollment

123

ACTUAL participants

Conditions

AlopeciaMale Pattern Hair Loss

Interventions

KX- 826 dosed at 2.5mg

DRUG

KX-826 dosed at 5mg

DRUG

KX-826 dosed at 5mg

DRUG

Matching placebo to KX-826

DRUG

Androgenic Alopecia TH07 Clinical Trial

NCT07435012

Androgenic Alopecia

View study

RECRUITINGPHASE1/PHASE2

A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of ALD-102 Solution in Subjects With Alopecia Areata

NCT06826196

Alopecia Areata (AA)

View study

RECRUITINGNA

Autologous Hair Follicle Secretome for Androgenic Alopecia (Single Site)

NCT07107841

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 22, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Androgenic Alopecia TH07 Clinical Trial

A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of ALD-102 Solution in Subjects With Alopecia Areata

Autologous Hair Follicle Secretome for Androgenic Alopecia (Single Site)

CorEvitas International Adolescent Alopecia Areata (AA) Drug Safety and Effectiveness Registry

Study to Evaluate the Efficacy and Safety of Deuruxolitinib in Adolescents With Severe Alopecia Areata

Combined Microneedling With Either 1% Lactic Acid Solution or Vitamin D3 or Triamcinolone Acetonide in The Treatment of Alopecia Areata