Acne
Conditions
Keywords
facial and truncal acne, Effaclar Duo+M, acne lesions
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.
Interventions
OTHERacneic participants group
Application of Effaclar Duo+M to the face and trunk twice daily (morning and evening) after washing with the cleansing gel.
Sponsors
Cosmetique Active International
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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). |
Countries
Brazil
Contacts
Primary ContactAlessandro Nascimento
Outcome results
None listed