Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-30 @ 2:53 AM
Study NCT ID:
NCT07457294
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-09
First Post:
2026-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
1% Clascoterone Cream for the Treatment Acne Vulgaris
Sponsor:
Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd.
Organization:
Study Overview
Official Title:
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of 1% Clascoterone Cream in the Treatment of Acne Vulgaris
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-02
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 is a multicenter, randomized, double-blind, parallel, placebo-controlled Phase III clinical study to evaluate the efficacy and safety of 1% Clascoterone Cream in the treatment of acne vulgaris.
Target population: Participants aged ≥12 years with moderate to severe acne vulgaris who meet the inclusion criteria and none of the exclusion criteria.
Treatment: The investigational group will receive 1% Clascoterone Cream, and the control group will receive placebo. Approximately 1 g of the cream will be applied evenly to the entire face twice daily (morning and evening) for 12 weeks.
Target population: Participants aged ≥12 years with moderate to severe acne vulgaris who meet the inclusion criteria and none of the exclusion criteria.
Treatment: The investigational group will receive 1% Clascoterone Cream, and the control group will receive placebo. Approximately 1 g of the cream will be applied evenly to the entire face twice daily (morning and evening) for 12 weeks.
Detailed Description:
None
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?: