Ignite Creation Date:
2024-07-17 @ 10:59 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06463925
Status:
RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-06-05
Brief Title:
Evaluation of Effaclar DuoM on Acne Lesions in Subjects With Mild to Moderate Acne on Face and Trunk
Sponsor:
Cosmetique Active International
Organization:
Cosmetique Active International
Study Overview
Official Title:
Evaluation of Effaclar DuoM on Inflammatory and Non-Inflammatory Lesions in Subjects With Mild to Moderate Acne on Face and Trunk Back and Chest
Status:
RECRUITING
Status Verified Date:
2024-06
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 single-center open non-randomized study aims the efficacy evaluation of Effaclar DuoM and EffaclarM Purifying foaming gel on total acne lesion count pigmented lesions and scars for 6 months in subjects with mild to moderate facial and truncal acne
Detailed Description:
The study will be conducted in accordance with the principles of Resolution 4662012 of the Conselho Nacional de Saúde do Brasil3 ethical principles from the Declaration of Helsinki and subsequent modifications and Good Clinical Practice
Statistical methodology
Quantitative variables or those that can reasonably be treated as such are summarized using the minimum maximum measures of central tendency such as the mean and median measures of dispersion such as the standard deviation SD Qualitative variables are summarized in the form of counts and percentages
Significance level
The null hypothesis will generally be rejected if a p-value less than 005 5 significance level is produced by the statistical procedure
Statistical methodology
Quantitative variables or those that can reasonably be treated as such are summarized using the minimum maximum measures of central tendency such as the mean and median measures of dispersion such as the standard deviation SD Qualitative variables are summarized in the form of counts and percentages
Significance level
The null hypothesis will generally be rejected if a p-value less than 005 5 significance level is produced by the statistical procedure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None