Androgenetic Alopecia (AGA)
Conditions
Keywords
KX-826 AGA
Brief summary
This is a multi-center, randomized, double-blind, placebo-controlled Phase II clinical study of KX-826 in Chinese adult male patients with AGA.
Detailed description
Based on the results of the Phase I studies of KX-826 in Androgenetic Alopecia and the pre-clinical PD studies, the investigational product will be administered at 2.5 mg BID (0.25%), 5 mg QD (0.5%), and 5 mg BID (0.5%) in treatment groups A, B, and C, respectively, with 30 patients/group; a total of 30 patients will be administered in the placebo QD group (10) and placebo BID group (20). The investigational product will be administered in the evening once daily for all QD dose groups, and once in the morning and once in the evening for the BID dose groups.
Interventions
DRUGKX-826-2.5 mg (0.25%)/60 mL BID
Topical application, 7 sprays (approximately 1 mL)/time, in the target area of the scalp (8 cm × 8 cm), starting from the center of the affected area, and massage with hands for 3-5 min. This dose is used regardless of the size of the affected area. It should be used when hair and scalp are completely dry. Wash hands after use. The control product will be administered once in the morning and once in the evening.
DRUGKX-826-5 mg (5%)/60 mL QD
Topical application, 7 sprays (approximately 1 mL)/time, in the target area of the scalp (8 cm × 8 cm), starting from the center of the affected area, and massage with hands for 3-5 min. This dose is used regardless of the size of the affected area. It should be used when hair and scalp are completely dry. Wash hands after use. The control product will be administered in the evening once daily.
DRUGKX-826-5 mg (5%)/60 mL BID
Topical application, 7 sprays (approximately 1 mL)/time, in the target area of the scalp (8 cm × 8 cm), starting from the center of the affected area, and massage with hands for 3-5 min. This dose is used regardless of the size of the affected area. It should be used when hair and scalp are completely dry. Wash hands after use. The control product will be administered once in the morning and once in the evening.
OTHERPlacebo
Topical application, 7 sprays (approximately 1 mL)/time, in the target area of the scalp (8 cm × 8 cm),starting from the center of the affected area, and massage with hands for 3-5 min. This dose is used regardless of the size of the affected area. It should be used when hair and scalp are completely dry. Wash hands after use. The control product will be administered in the evening once daily for QD dose groups, and once in the morning and once in the evening for the BID dose groups.
Sponsors
Suzhou Kintor Pharmaceutical Inc,
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Agreeing to follow the study treatment regimen and visit plan, voluntarily enroll the study, and sign the informed consent form (ICF) in writing; 2. Male, aged ≥ 18 years, in good general health; 3. Clinical diagnosis of AGA; 4. Stage IIIv, IV and V according to Hamilton-Norwood scale.
Exclusion criteria
1. Patients who have used external topical drugs for alopecia sites within 3 months prior to screening; 2. Patients who have taken androgen replacement therapy； immunosuppressants, corticosteroids and other drugs that may interfere with the efficacy evaluation within 3 months prior to screening; 3. Minoxidil use within 6 months prior to screening; 4. Treatment with finasteride or dutasteride within 12 months prior to screening; Scalp radiation and/or laser or surgical therapy within 12 months prior to screening; History of malignancy; 5. Other conditions that may affect compliance or ineligibility for participation of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in non-vellus hair count in the target area (TAHC, mean change from baseline at Week 24). | mean change from baseline after 24 weeks of treatment | change in non-vellus hair count in the target area (TAHC, mean change from baseline at Week 24). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hair growth assessment (HGA), including patient self-assessment, investigator assessment, and third-party professional physician assessment | change from baseline after 6, 12, 18, and 24 weeks of treatment, assessed using a 7-category method | Hair growth assessment (HGA), including patient self-assessment, investigator assessment, and third-party professional physician assessment |
| Change in non-vellus hair diameter (width) in the target area (TAHW) (change from baseline at Weeks 6, 12, 18, 24 of treatment) | change from baseline after 6, 12, 18, and 24 weeks of treatment | Change in non-vellus hair diameter (width) in the target area (TAHW) (change from baseline at Weeks 6, 12, 18, 24 of treatment) |
Countries
China
Outcome results
None listed