Effectiveness and Tolerance of Effaclar Serum in Women With Mandibular Acne

The study is performed in the Centre de Pharmacologie Clinique Appliqué à la Dermatologie (CPCAD), authorized by the French Regional Agency of Health (ARS) to perform biomedical research (Site agreement n°: 2016-04).

This clinical trial protocol and all amendments will be reviewed and approved by an appropriate Independent Ethics Committee (IEC) (Comité de Protection des Personnes (CPP)) located in France. The clinical trial cannot start before CPP approval.

The clinical trial is conducted under the sponsorship of Sponsor in compliance with the applicable international and local regulatory requirements as well as applicable International Council on Harmonisation (ICH) guidelines and in accordance with the Standard Operating Procedures (SOPs) for clinical trial conduct and monitoring from the assigned monitor.

All statistical tests will be two-sided and at the 5% level of significance. Normality tests will be at the 1% level of significance (Shapiro-Wilk).

Regarding the analysis of efficacy endpoints, quantitative parameters are analyzed using a linear mixed model for repeated measurements with Baseline and Time as fixed effects and Subject as random effect. Each time-point is compared to Baseline using a Dunes adjustment for multiplicity correction. For each fitted model, residual plots will be used to check the model assumptions. If there is an obvious deviation to these assumptions, the analysis is done on the rank-transformed data. Ordinal parameters (GEA) are analyzed using a cumulative link mixed model for repeated measurements with Baseline and Time as fixed effects and Subject as random effect. Each time-point will be compared to Baseline using a Dunnett adjustment for multiplicity correction.

The analysis of cosmeticity/acceptability questionnaire is descriptive only and for the analysis of safety endpoints, no statistical analysis is performed on safety. The data are presented descriptively.

As for the sample size determination, a total of 30 subjects completing the whole study allows to answer to the study objectives.

Clinical Research Associates (CRAs) and other applicable personnel are trained prior to study initiation to familiarize CRAs with the disease, the Standard Operating Procedures (SOP), the protocol and other study specific items.

Regarding the data management, the study data will be collected on an electronic data capture (EDC) set up by the Contract Research Organization (CRO). Computerized edit checks and review processes will be performed on an ongoing basis until all data clarifications are resolved. The data will be exported from a special database to be stored in appropriate format. After all data clarifications are resolved, coding is approved, and subject's evaluability is determined, the database will be locked.

Inclusion criteria

• female subjects aged 20 years or above
• phototype II to IV
• mandibular acne (with or without diffuse acne)
• at baseline (Day0) a AFAST (Adult Female Acne Scoring Tool) score of 1 or 2 in the mandibular area and not over
• 15 non-inflammatory lesions and 5 inflammatory lesions minimum (screening and baseline)
• microcomedones on the mandibular area (visible with Vivacube measurement),

Exclusion criteria

• men
• female subject pregnant or lactating or who intends to conceive a child during the clinical trial or within one month after the last clinical trial visit
• facial acne without mandibular acne
• still undergoing medical treatment for acne at baseline (D0)
• intensively exposed to UV within the month preceding the baseline visit
• history of any severe disease or current condition (based on subject's interview and/or results of screening physical examination) which, in the opinion of the Investigator would put the subject at risk by participating in the study or would interfere significantly with the evaluation of study results (e.g. cancer, immune disorders)