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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-07

Study Completion Date

2024-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Acne

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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acneic participants group

subjects with mild to moderate facial and truncal acne

Group Type OTHER

acneic participants group

Intervention Type OTHER

Application of Effaclar Duo+M to the face and trunk twice daily (morning and evening) after washing with the cleansing gel.

Interventions

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acneic participants group

Application of Effaclar Duo+M to the face and trunk twice daily (morning and evening) after washing with the cleansing gel.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes