Ignite Creation Date:
2024-05-05 @ 11:24 PM
Last Modification Date:
2024-10-26 @ 10:33 AM
Study NCT ID:
NCT01326780
Status:
COMPLETED
Last Update Posted:
2019-10-16
First Post:
2011-03-30
Brief Title:
A Study of a New Drug Treatment for Acne
Sponsor:
Bausch Health Americas Inc
Organization:
Bausch Health Americas Inc
Study Overview
Official Title:
A Multi-Center Double-Blind Vehicle Controlled Phase II Study of JNJ 10229570-AAA for the Treatment of Acne Vulgaris
Status:
COMPLETED
Status Verified Date:
2019-10
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:
A study to determine if three different doses of a new acne treatment are safe and better at reducing facial acne than a treatment without active ingredient
Detailed Description:
Approximately 400 male and female subjects with moderate facial acne vulgaris will be enrolled in this randomized multi-center study Following satisfaction of entry criteria and screening procedures subjects will be randomized to either 12 24 or 36 facial cream JNJ 10229570-AAA or color-matched vehicle Subjects will apply the study medication once daily on the face for 12 weeks Safety will be monitored throughout the study duration Efficacy will be assessed by facial lesion counts and by the investigator global evaluation of acne severity at Baseline and at Weeks 2 4 6 8 10 and 12 Approximately 50 subjects from one investigational site also will have serums collected at Weeks 6 and 12 for evaluation of the multiple dose pharmacokinetics of JNJ 10229570-AAA cream
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