Evaluation of Effaclar Duo+M on Acne Lesions in Subjects With Mild to Moderate Acne on Face and Trunk
- Conditions
- Acne
- Interventions
- Other: acneic participants group
- Registration Number
- NCT06463925
- Lead Sponsor
- Cosmetique Active International
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 65
- phototype I to VI
- mild to moderate acne on the face and trunk
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description acneic participants group acneic participants group subjects with mild to moderate facial and truncal acne
- Primary Outcome Measures
Name Time Method efficacy on total acne lesion count on face and trunk 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.
- Secondary Outcome Measures
Name Time Method Evaluation of the degree of severity of acne on the trunk 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).
Evaluation of the degree of severity of acne on the face 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).
Trial Locations
- Locations (1)
CIDP Brasil
🇧🇷Rio De Janeiro, Brazil