Ignite Creation Date:
2024-05-05 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00421993
Status:
COMPLETED
Last Update Posted:
2021-02-18
First Post:
2007-01-11
Brief Title:
A Study to Demonstrate the Efficacy and Safety of AdapaleneBenzoyl Peroxide Topical Gel in Subjects With Acne Vulgaris
Sponsor:
Galderma RD
Organization:
Galderma RD
Study Overview
Official Title:
A Multi-Center Randomized Double-Blind Parallel-Group Study to Demonstrate the Efficacy and Safety of AdapaleneBenzoyl Peroxide Topical Gel Compared With Adapalene Topical Gel 01 Benzoyl Peroxide Topical Gel 25 and Topical Gel Vehicle in Subjects With Acne Vulgaris
Status:
COMPLETED
Status Verified Date:
2009-10
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:
This is a multi-center randomized double-blind parallel group study with 12 weeks of treatment of acne vulgaris Efficacy and safety evaluations will be performed at Screening safety only Baseline and Weeks 1 2 4 8 and 12 All Investigators Global Assessment evaluators and lesion counters must be trained and approved by Galderma The evaluator of a subject should remain the same during the study
The primary objective is to demonstrate the superiority in efficacy and assess safety of AdapaleneBenzoyl Peroxide Topical Gel AdapaleneBenzoyl Peroxide Gel versus Adapalene Topical Gel 01 Adapalene Monad Benzoyl Peroxide Topical Gel 25 Benzoyl Peroxide Monad and Topical Gel Vehicle Gel Vehicle in the treatment of acne vulgaris for up to 12 weeks
The primary objective is to demonstrate the superiority in efficacy and assess safety of AdapaleneBenzoyl Peroxide Topical Gel AdapaleneBenzoyl Peroxide Gel versus Adapalene Topical Gel 01 Adapalene Monad Benzoyl Peroxide Topical Gel 25 Benzoyl Peroxide Monad and Topical Gel Vehicle Gel Vehicle in the treatment of acne vulgaris for up to 12 weeks
Detailed Description:
None
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