Acne Clinical Trial
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
Verified date | July 2022 |
Source | Cosmetique Active International |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | May 25, 2010 |
Est. primary completion date | May 25, 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 15 Years to 30 Years |
Eligibility | 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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Cosmetique Active International |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | change in the lesion count | counting of non-inflammatory (open and closed comedones) and inflammatory (papules, pustules) lesions | from baseline to month 6 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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