Clinical trial NCT05469880: Efficacy and Tolerance of Formula 609613 37 in Acneic Patients
Official title: Evaluation of the Efficacy and Tolerance of Formula 609613 37 in Acneic Patients as an Adjunct to and in Addition to 5% Benzoyl Peroxide for 6 Months
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acne
Keywords: acne
lipohydroxyacid
salicylic acid
benzoyl peroxide
dermocosmetic
Lead sponsor: Cosmetique Active International
Sponsor class: INDUSTRY
First posted: 2022-07-22
Enrollment: 100
Sex: ALL
Minimum age (years): 15
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: change in the composite score
timeFrame: from baseline to month 6
Secondary outcomes:
measure: change in the lesion count
timeFrame: from baseline to month 6
measure: change in the evaluation of skin sensitivity by the patient
timeFrame: from baseline to month 6
measure: change in the evaluation of global tolerance by the patient
timeFrame: from baseline to month 6
measure: change in the evaluation of the efficacy by the investigator and patient
timeFrame: from baseline to month 6
measure: change in the evaluation of the global efficacy by the investigator
timeFrame: from baseline to month 6
measure: change in the quality of life
timeFrame: from baseline to month 6
Other outcomes:
Locations:
Study officials:
References: