Clinical trial NCT05457621: Effectiveness and Tolerance of Effaclar Serum in Women With Mandibular Acne
Official title: Evaluation of the Effectiveness and Tolerance of Effaclar Ultra Concentrated Serum in Women With Mandibular Acne for 3 Months (Including 2 Months of Treatment)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acne Vulgaris
Keywords: tri-acid complex serum
mandibular acne
microcomedones
maintenance regimen
Lead sponsor: Cosmetique Active International
Sponsor class: INDUSTRY
First posted: 2022-07-14
Enrollment: 30
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants attend 7 visits (screening visit, inclusion visit, 4 intermediate visits, final visit) and make a visit by phone call at Day48 hours. They apply the investigational product once daily (evening) for 2 months on the whole face and the accompanying product twice daily for 3 months on the whole face.
Primary purpose: TREATMENT

Brief summary: The role of "dermocosmetics" in acne management is increasingly important, as many patients and even physicians now resort to them as first-line management in mild-to-moderate acne.

The aim of the study is to demonstrate the efficacy of the tested product on the appearance of acne lesions in 30 adult women suffering from acne in the mandible following an active anti-acne therapy (systemic or topical). This study includes 2 months of cosmetic treatment with EFFACLAR Ultra Concentrated Serum and one month of followup without any treatment but a moisturizer with a daily UV protection.

The investigational product has been formulated with an ultra-concentrated tri-acids complex for a synergetic action on skin and reinforced with soothing niacinamide for optimal tolerance.

This product is expected:

* to leave the skin clean and smooth,
* to help unblock pores,
* to exfoliate dead skin cells and help the skin to appear smoother, softer and pore-less,
* to be non-comedogenic.

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: change in GEA (Global Evaluation Acne) score
timeFrame: from baseline to Day84
measure: change in Adult Female Acne Scoring Tool (AFAST) score
timeFrame: from baseline to Day84
measure: change in acne count
timeFrame: from baseline to Day84
measure: change in the seborrhea evaluation
timeFrame: from baseline to Day84
Secondary outcomes:
measure: change in subject's and Investigator's global assessment of efficacy
timeFrame: from Day7 to Day84
measure: change in the quantity of sebum
timeFrame: from baseline to Day84
measure: change in the quality of life
timeFrame: Day0, Day14, Day28, Day56, Day84
measure: change in the global tolerance
timeFrame: from Day7 to Day84
measure: change in the sensitivity assessment by the investigator
timeFrame: from Day48 hours (phone call) to Day84
measure: change in the sensitivity assessment by the participant
timeFrame: from Day48 hours (phone call) to Day84
Other outcomes:
Locations:
city: Nice
country: France
facility: Centre de Pharmacologie Clinique Appliquée à la Dermatologie (CPCAD)
Study officials:
affiliation: Centre de Pharmacologie Clinique Applique a la Dermatologie
name: Catherine Queille-Roussel
role: STUDY_DIRECTOR
References: