The objective of an acnegenicity or comedogenicity study is to support the non-comedogenic/non-acnegenic claim for a product under normal or exaggerated use conditions. This study may be combined with a Safety-In-Use study to also determine the potential of the product to irritate the skin. For statistical relevance, it is recommended that no fewer than 30 subjects complete the study, however, the more subjects tested, the more reliable the results will be. The duration of the study is typically four weeks or six weeks, with daily (or more frequent) applications to the face. Eurofins CRL technical staff can help advise on study design for your specific product.
Individual units of the test product must be provided by you, the Sponsor, in a quantity sufficient to last each subject for the number of required uses. Eurofins CRL staff will label each unit with identifying study and subject numbers prior to distribution. At the baseline visit, potential subjects will be evaluated to confirm the absence of irritation or abnormal dermal conditions on the face. Qualified subjects who have self-assessed normal to oily or “acne-prone” skin will then have a count of inflammatory lesions (papules and pustules) and non-inflammatory lesions (open and closed comedones) performed by a dermatologist or trained staff. Subjects are then provided with the test products, instructions for use, and a daily diary in which to record each use. At the end of the specified study period, subjects return for a final, post-use evaluation. Lesion counts are repeated and total number of each lesion type is recorded. If desired, a final questionnaire may be provided for completion by each subject in order to obtain consumer opinion of product attributes.
Interpretation & Reporting of Results
Following study completion, the change in lesion counts from baseline to final visit is determined for each lesion type (papules, pustules, open comedones, and closed comedones). If no statistically significant increase in non-inflammatory lesions exists, the non-comedogenic claim can be made. If there is no statistically significant increase in total lesion count, combining inflammatory and non-inflammatory lesions, the non-acnegenic claim is supported.
At the request of the Sponsor, topline results may be provided verbally or in writing after statistical analysis has been performed. A written Final Report follows shortly thereafter.
Scheduling an Acnegenicity/Comedogenicity Study
To schedule, please contact your Client Services representative at 732-981-1616 or contact us by e-mail: firstname.lastname@example.org