Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06415305
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-05-10
Brief Title:
A Study Evaluating the Efficacy and Safety of Clascoterone Cream 1 in Skin of Color Patients With Acne
Sponsor:
Sun Pharmaceutical Industries Limited
Organization:
Sun Pharmaceutical Industries Limited
Study Overview
Official Title:
The Efficacy and Safety of Winlevi in Skin of Color Patients With Acne
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-02
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:
Acne vulgaris is the most common skin disease in patients with skin of color and second most common in Caucasian population The global prevalence is thought to be as high as 60-80 in individuals 12-25 years of age However it is not limited to only teenagers but also to adults especially adult females The pathogenesis of acne is multifactorial Genetics may also play a role The treatment pathway should be directed to different pathogenic factors including excessive sebum production hyper keratinization P acnes and inflammation
Data is limited for skin of color patients in Phase III registration trials Data is limited because there a few studies that focus on patients with skin of color Therefore a unique study dedicated to patients with skin of color in a real-world setting will be welcome to add further evidence to phase III data
Data is limited for skin of color patients in Phase III registration trials Data is limited because there a few studies that focus on patients with skin of color Therefore a unique study dedicated to patients with skin of color in a real-world setting will be welcome to add further evidence to phase III data
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None