Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06409650
Status:
COMPLETED
Last Update Posted:
2024-05-22
First Post:
2024-05-07
Brief Title:
To Evaluate Safety and Efficacy of KX-826 in Chinese Female Subjects With Androgenetic Alopecia
Sponsor:
Suzhou Koshine Biomedica Inc
Organization:
Suzhou Kintor Pharmaceutical Inc
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 25 mg QD 25 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 Countsat Week 24 in comparison to placebo
Study Oversight
Has Oversight DMC:
None
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?:
None