NCT06126965

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

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)

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 740 (actual)
• Sponsor: Suzhou Kintor Pharmaceutical Inc, · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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

• Androgenetic Alopecia

Interventions

Type	Name	Description
DRUG	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.
OTHER	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.

Timeline

• Start date: 2021-12-29
• Primary completion: 2024-05-31
• Completion: 2024-05-31
• First posted: 2023-11-13
• Last updated: 2024-04-03

Locations

26 sites across 1 country: China