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, 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)