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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| moisturizing cream and 5% benzoyl peroxide gel | Active Comparator | 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. |
|
| anti-acne face cream and 5% benzoyl peroxide gel | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| moisturizing cream and 5% benzoyl peroxide gel | Other | 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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The creams are packaged in white tubes with specific labelling that does not allow to identify them. The 5% benzoyl peroxide tubes are delivered in commercial form.
| anti-acne face cream and 5% benzoyl peroxide gel | Other | 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 |
|
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 |