This single-center, open, non-randomized study aims the efficacy evaluation of EffaclarDuo+M and Effaclar+M Purifying foaming gel on total acne lesion count, pigmented lesionsand scars for 6 months in subjects with mild to moderate facial and truncal acne.
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.
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.
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
CIDP Brasil
Rio de Janeiro 3451190, Brazil
Investigator: Alessandro Nascimento
Contact: +55 21 98726-2046
a.nascimento@cidp-cro.com
Alessandro Nascimento
+55 21 98726-2046
a.nascimento@cidp-cro.com
Renato Moura, Principal Investigator
Centre International de Développement Pharmaceutique (CIDP)