Efficacy and Tolerance of Formula 609613 37 in Acneic Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Acne

Intervention / Treatment
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* Other: moisturizing cream and 5% benzoyl peroxide gel
* Other: anti-acne face cream and 5% benzoyl peroxide gel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: moisturizing cream and 5% benzoyl peroxide gel<br>Participants apply the 5% benzoyl peroxide gel every evening and the moisturizing cream every morning for 3 months. Then they are divided into 2 groups: one applies the anti-acne face cream every morning for 3 months and the other one the moisturizing cream every morning for 3 months. | Other: moisturizing cream and 5% benzoyl peroxide gel<br>* 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<br>|
| Experimental: anti-acne face cream and 5% benzoyl peroxide gel<br>Participants apply the 5% benzoyl peroxide gel every other night and the anti-acne face cream every morning for 3 months. Then they are divided into 2 groups: one applies the anti-acne face cream every morning for 3 months and the other one the moisturizing cream every morning for 3 months. | Other: anti-acne face cream and 5% benzoyl peroxide gel<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | from baseline to month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in the lesion count | counting of non-inflammatory (open and closed comedones) and inflammatory (papules, pustules) lesions | from baseline to month 6 | 
| change in the evaluation of skin sensitivity by the patient | evaluation of the skin sensitivity (pruritus, tingling sensation, burning sensation) on a 4-point scale (from Absent to Important) | from baseline to month 6 | 
| change in the evaluation of global tolerance by the patient | evaluation on a 4-point scale (from Nil to Excellent) | from baseline to month 6 | 
| change in the evaluation of the efficacy by the investigator and patient | evaluation on a 4-point scale (from Nil to Excellent) | from baseline to month 6 | 
| change in the evaluation of the global efficacy by the investigator | evaluation on a 6-point scale (from No lesion to Very severe) | from baseline to month 6 | 
| change in the quality of life | evaluation of the quality of life of patients with the Cardiff Acne Disability Index (CADI) score | from baseline to month 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acne, lipohydroxyacid, salicylic acid, benzoyl peroxide, dermocosmetic