Efficacy and Tolerance of Formula 609613 37 in Acneic Patients

Cosmetique Active International100 enrolled

Overview

Acne affects most adolescents and young adults with varying severity and presentation. For early or localized forms, the first-line treatment is usually local. The available treatments often lead to local irritation, particularly during the first few weeks of use. This is why creams containing exfoliating agents have long been used in acne, as they are considered to allow a faster disappearance of superficial lesions. The objective of this 6-month double-blind study is to demonstrate in 100 acneic patients the interest of an anti-acne face cream as an adjunct to and in addition to a 5% benzoyl peroxide gel.

The study is conducted in accordance with the protocol and the legislative and regulatory provisions in force (after obtaining authorization of the French health authorities and the favorable opinion of the ethics committee). Regarding the statistical analysis, two different analysis are performed: * Descriptive analysis: quantitative variables are described by the mean and standard deviation and qualitative variables by the raw number of each modality and the corresponding percentage. * Comparative analysis: for quantitative variables, inter-group comparisons are made by a Student's T-test or a non parametric Mann-Whitney test if necessary. For qualitative variables, comparisons are made using a Chi-square test, if the expected number of participants is less than 5, Fischer's exact test on a 4-box contingency tables is used. A significant level of p \<0.05 is considered as significant. A double-data entry is carried out then a comparison of the two databases is performed. Finally internal and external consistency tests are planned. Missing data are described and possibly analyzed.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

100

Conditions

Acne

Interventions

moisturizing cream and 5% benzoyl peroxide gelOTHER

Group A: Eclaran 5% every evening and formula 609567 49 every morning, for 3 months. Then the group is divided: Group A1/ formula 609613 37 and Group A2/ formula 609567 49 every morning, for the next 3 months

anti-acne face cream and 5% benzoyl peroxide gelOTHER

Group B: Eclaran 5% every other night and 609613 37 every morning, for 3 months. Then the group is divided: Group B1/ 609613 37 and Group B2/ formula 609567 49 every morning, for the next 3 months

Eligibility

Sex: ALLMin age: 15 YearsMax age: 30 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * acneic facial skin * between 20 and 50 non-inflammatory lesions on the face * between 10 and 40 superficial inflammatory lesions on the face * no local acneic treatment in the previous 15 days * no treatment with isotretinoin in the previous 3 months * agreeing to apply only the study products Exclusion Criteria: * less than 20 or more than 50 non-inflammatory lesions on the face * less than 10 or more than 40 superficial inflammatory lesions on the face * prescription of a local acne treatment for less than 15 days * prescription of an antibiotic treatment for less than 1 month * prescription of an isotretinoin treatment for less than 3 months * changing toiletries and hygiene products regularly

Outcomes

Primary Outcomes

change in the composite score

the investigator evaluates i) the skin sensitivity (erythema, desquamation) and ii) the global tolerance on a 4-point scale (i) from Absent to Important and ii) from Nil to Excellent)