Evaluation of Effaclar Duo+M on Acne Lesions in Subjects With Mild to Moderate Acne on Face and Trunk

June 14, 2024 updated by: Cosmetique Active International

Evaluation of Effaclar Duo+M on Inflammatory and Non-Inflammatory Lesions in Subjects With Mild to Moderate Acne on Face and Trunk (Back and Chest)

This single-center, open, non-randomized study aims the efficacy evaluation of Effaclar Duo+M and Effaclar+M 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study will be conducted in accordance with the principles of Resolution 466/2012 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 0.05 (5% significance level) is produced by the statistical procedure.

Study Type

Interventional

Enrollment (Estimated)

65

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • phototype I to VI
  • mild to moderate acne on the face and trunk

Exclusion Criteria:

  • cutaneous pathology on the studied zone other than acne
  • topical or systemic treatment during the previous weeks liable to interfere with the assessment of the acceptability and efficacy of the studied products

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: acneic participants group
subjects with mild to moderate facial and truncal acne
Other: acneic participants group
Application of Effaclar Duo+M to the face and trunk twice daily (morning and evening) after washing with the cleansing gel.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
efficacy on total acne lesion count on face and trunk
Time Frame: from baseline to Day168
The counting is performed by region (back, chest, face, total) and type of lesion (post-inflammatory hyperpigmentation, post-inflammatory erythema, scars, pustules, nodules, papules, closed comedones, open comedones.
from baseline to Day168

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the degree of severity of acne on the face
Time Frame: from baseline to Day168
Evaluation performed thanks to the Global Evaluation Acne (GEA) scale on a 6-point score: from 0 (Clean. No lesions) to 5 (Very severe).
from baseline to Day168
Evaluation of the degree of severity of acne on the trunk
Time Frame: from baseline to Day168
Evaluation performed thanks to the Investigator Global Assessment (IGA) scale on a 6-point score: from 0 (Absent) to 5 (Very serious).
from baseline to Day168

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cosmetique Active International

Investigators

  • Principal Investigator: Renato Moura, Centre International de Développement Pharmaceutique (CIDP)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 7, 2023

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

June 5, 2024

First Submitted That Met QC Criteria

June 14, 2024

First Posted (Actual)

June 18, 2024

Study Record Updates

Last Update Posted (Actual)

June 18, 2024

Last Update Submitted That Met QC Criteria

June 14, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LRP23014-2223CBCL059 Effaclar

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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