Ignite Creation Date:
2025-12-24 @ 4:59 PM
Ignite Modification Date:
2026-01-09 @ 12:54 PM
Study NCT ID:
NCT06409650
Status:
COMPLETED
Last Update Posted:
2024-05-22
First Post:
2024-05-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Evaluate Safety and Efficacy of KX-826 in Chinese Female Subjects With Androgenetic Alopecia
Sponsor:
Suzhou Koshine Biomedica, Inc.
Organization:
Study Overview
Official Title:
A Phase II, Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate the Safety and Efficacy of KX-826 Tincture for Topical Use in Chinese Adult Female Patients With Androgenetic Alopecia (AGA)
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This was a multi-center, randomized, double-blind, placebo-controlled Phase II clinical study of KX-826 Tincture in Chinese adult female subjects with AGA.
Detailed Description:
KX-826 is a new investigational androgen receptor (AR) antagonist for the treatment of female pattern hair loss (androgenetic alopecia). A total of 160 female subjects were randomized to one of four cohorts: 2.5 mg QD, 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: