Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06415279
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-05-10
Brief Title:
A Study to Evaluate the Reduction in Sebum Skin Oil Induced by Clascoterone Cream 1 in Acne Patients
Sponsor:
Sun Pharmaceutical Industries Limited
Organization:
Sun Pharmaceutical Industries Limited
Study Overview
Official Title:
Clinical Evaluation of the Sebum Reduction Induced by Clascoterone Cream 1
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
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:
The etiology of acne is heavily dependent on the production of sebum by the sebaceous glands that results in the growth of the bacteria c acnes If no sebum is present there is no nutritional source for the c acnes the bacteria die and acne resolves A newly FDA approved acne medication consisting of clascoterone cream 1 is believed to effectively treat acne due to a decrease in sebum production This mechanism of action has been postulated based on efficacy observed in the phase III trials that lead to its approval This research aims to demonstrate the effect of clascoterone cream 1 in sebum reduction
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