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Abstract
How is the nonacnegenic potential of a topical product clinically supported? The answer to that question is in three parts: a review of available preclinical assays, a review of available clinical assays, and a proposed protocol to assess clinically the acnegenicity of topical products.
Acnegenicity has two components: comedogenicity (the noninflammatory acne lesion component; closed and open comedones) and follicular inflammation (the inflammatory acne lesion component; papules, pustules, and nodules). Preclinical assays assess either the comedogenicity component of the process of acnegenicity (rabbit ear assay) or one part of the follicular inflammation component (rabbit skin pustulogenicity assay). Data from these assays are not consistent from laboratory to laboratory. Furthermore, there is the question of the applicability of preclinical test results to human acne. The best use of these preclinical assays has been to detect strong comedogens such as chloracnegenic compounds (rabbit ear assay) or strong pustulogens such as the halides (rabbit skin pustulogenicity assay).
A comprehensive product development plan will be reviewed and a proposed modification to the 90-day over-the-counter acne monograph's effectiveness protocol will be described and proposed to support the nonacnegenic potential of topical products.