Phase III Study of KX-826 With Adult Male Patients With AGA

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

740 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-29

Study Completion Date

2024-05-31

Brief Summary

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This is a phase III, multi-center, randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy and safety of KX-826 for topical use in Chinese adult male patients with androgenetic alopecia (AGA).

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Detailed Description

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In this study, around 740 adult male subjects with AGA (rating IIIv, IV and V on Hamilton-Norwood scale) were to be enrolled. All subjects would be evaluated with 1:1 randomized to receive active drug or placebo in a double-blind fashion (370 subjects in each group), and would be treated for 24 weeks at the specified dose and frequency of each group. During the study, the subjects would undergo periodic efficacy and safety-related examinations and evaluation.

Conditions

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Androgenetic Alopecia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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KX-826-0.5% BID

treatment dose group of 0.5% BID(0.5%)

Group Type EXPERIMENTAL

KX-826-（5%） BID

Intervention Type DRUG

Dosage and administration: Topical application, 7 sprays (approximately 1 ml)/time, in the target area of the scalp, starting from the center of the affected area and massaging with hands until absorption. It should be used when the hair and scalp are completely dry. Wash hands after use. The randomized active drug would be administered to the scalp once in the morning and once in the evening.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Dosage and administration: Topical application, 7 sprays (approximately 1 ml)/time, in the target area of the scalp, starting from the center of the affected area and massaging with hands until absorption. It should be used when the hair and scalp are completely dry. Wash hands after use. The randomized matching placebo would be administered to the scalp once in the morning and once in the evening.

Interventions

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KX-826-（5%） BID

Dosage and administration: Topical application, 7 sprays (approximately 1 ml)/time, in the target area of the scalp, starting from the center of the affected area and massaging with hands until absorption. It should be used when the hair and scalp are completely dry. Wash hands after use. The randomized active drug would be administered to the scalp once in the morning and once in the evening.

Intervention Type DRUG

Placebo

Dosage and administration: Topical application, 7 sprays (approximately 1 ml)/time, in the target area of the scalp, starting from the center of the affected area and massaging with hands until absorption. It should be used when the hair and scalp are completely dry. Wash hands after use. The randomized matching placebo would be administered to the scalp once in the morning and once in the evening.

Intervention Type OTHER

Other Intervention Names

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KX-826-5 mg(5%)60mL BID

Eligibility Criteria

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Inclusion Criteria

1. Agree to follow the study treatment regimen and visit plan, voluntarily enroll in the study, and sign the ICF in writing;
2. Male, ≥ 18 old;
3. Clinically diagnosed as androgenetic alopecia;
4. Rating IIIv, IV and V on Hamilton-Norwood scale;

Exclusion Criteria

1. Have used androgen replacement therapy, immunosuppressants, corticosteroids and other drugs that may affect the efficacy evaluation within 3 months prior to screening;
2. Have used minoxidil within 6 months prior to screening;
3. Have used finasteride or dutasteride within 12 months prior to screening;
4. Had used topical drugs for alopecia sites within 3 months prior to screening;
5. Have received scalp radiation and/or laser or surgical therapy within 12 months prior to screening;
6. Those who, in the opinion of the investigator, have other conditions that may affect compliance or are not suitable for participation in this study.

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jianzhong Zhang

Role: PRINCIPAL_INVESTIGATOR

Peking University People's Hospital

Qinping Yang

Role: PRINCIPAL_INVESTIGATOR

Huashan Hospital

Locations

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