Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06622824
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-29
Brief Title:
To Evaluate Efficacy and Safety of TopicalKX-826 Solution in Chinese Male Patients With Androgenetic Alopecia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy and Safety of Topical KX-826 Solution in Chinese Male Patients With Androgenetic Alopecia A Multicenter Randomized Double-blind Vehicle Controlled Adaptive Design Phase 23 Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a multicenter randomized double-blind vehicle controlled adaptive design phase 23 study to evaluate the efficacy and safety of topical KX-826 solution in Chinese male patients with androgenetic alopecia AGA It consisted of two phases phase 2 dose exploration trial and phase 3 confirmatory trial
Detailed Description:
In phase 2 study around 90 adult male subjects with AGA rating IIIv IV and V on Hamilton-Norwood scale were to be enrolled All subjects would be evaluated with 111 randomized to receive KX-826 05 BID KX-826 10 BID and vehicle in a double-blind fashion 30 subjects in each group and would be treated for 24 weeks at the specified dose During the study the subjects would undergo periodic efficacy and safety-related examinations and evaluation A Phase 2 statistical analysis will be performed when 90 patients complete the Week 24 visit or early withdrawal visit
Blood samples will be collected at the following time points
Day 1 3 hours pre-dose W6 Day 42 3 hours pre-dose W12 Day 84 3 hours pre-dose
In phase 3 study around 666 adult male subjects with AGA rating IIIv IV and V on Hamilton-Norwood scale were to be enrolled All subjects would be evaluated with 111 randomized to receive KX-826 05 BID KX-826 10 BID and vehicle in a double-blind fashion 222 subjects in each group and would be treated for 24 weeks at the specified dose During the study the subjects would undergo periodic efficacy and safety-related examinations and evaluation
Blood samples will be collected at the following time points
Day 1 3 hours pre-dose W6 Day 42 3 hours pre-dose W12 Day 84 3 hours pre-dose
In phase 3 study around 666 adult male subjects with AGA rating IIIv IV and V on Hamilton-Norwood scale were to be enrolled All subjects would be evaluated with 111 randomized to receive KX-826 05 BID KX-826 10 BID and vehicle in a double-blind fashion 222 subjects in each group and would be treated for 24 weeks at the specified dose During the study the subjects would undergo periodic efficacy and safety-related examinations and evaluation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None