Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00446043
Status:
COMPLETED
Last Update Posted:
2023-07-11
First Post:
2007-03-08
Brief Title:
Long-term Study of EfficacySafety of AdapaleneBenzoyl Peroxide Topical Gel in Acne Vulgaris Subjects
Sponsor:
Galderma RD
Organization:
Galderma RD
Study Overview
Official Title:
A Long-term Safety and Efficacy Study of a Fixed Combination of Adapalene 01 and Benzoyl Peroxide 25 Adapalene and Benzoyl Peroxide Topical Gel Gel in Subjects With Acne Vulgaris
Status:
COMPLETED
Status Verified Date:
2022-08
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 was a multi-center open-label non-comparative study that evaluated the long-term safety and efficacy profile of AdapaleneBenzoyl Peroxide Gel
Subjects were evaluated at Baseline Weeks 1 and 2 and Months 1 2 4 6 8 10 and 12
Safety was evaluated by spontaneous reports of Adverse Events AEs the Local Tolerability Assessment Erythema Scaling Dryness and StingingBurning routine laboratory testing hematology blood chemistry and urinalysis and monitoring of suspected sensitizations Efficacy was evaluated by analysis of Percent Change from Baseline in Inflammatory Noninflammatory and Total Lesion Counts and by the Subjects Assessment of Acne
Subjects were evaluated at Baseline Weeks 1 and 2 and Months 1 2 4 6 8 10 and 12
Safety was evaluated by spontaneous reports of Adverse Events AEs the Local Tolerability Assessment Erythema Scaling Dryness and StingingBurning routine laboratory testing hematology blood chemistry and urinalysis and monitoring of suspected sensitizations Efficacy was evaluated by analysis of Percent Change from Baseline in Inflammatory Noninflammatory and Total Lesion Counts and by the Subjects Assessment of Acne
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