Abstract
AbstractA detailed description and application of the controlled use test in a cosmetic product safety substantiation program is provided by the authors. The key elements of protocol, product, and panelists are discussed in detail, together with the responsibilities of the study sponsor and the clinical investigator. Current modifications of the controlled use test are summarized and new modifications are proposed to expand the application of the test beyond safety parameters to effectiveness, and claim substantiation, product performance, chemical stability and microbiological integrity parameters as well. The data generated in the controlled use test is directly applicable to actual consumer use situations.
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