PREVENTING IRRITANT CONTACT DERMATITIS:
AN IN VIVO HUMAN STUDY
March 17, 1998

Study Director: Howard Maibach, M.D.
Principal Investigator: Hongbo Zhai, M.D.
Technical Assistance: Alessandra Pelosi, M.D.

Prepared by:
Hongbo Zhai, M.D.
Department of Dermatology
University of California
San Francisco, CA 94143

STUDY OBJECTIVE
This study was to evaluate the efficacy of a Protèque formulation against sodium lauryl sulfate (SLS) induced irritation by visual grading and bioengineering techniques in humans.

1) Visual scoring (VS) of erythema showed a decrease on the Protèque pretreated testing site in comparison to SLS only treated site; and it also significantly decreased the VS on Protèque pretreated testing site in comparison to placebo control pretreated testing site, for the five days. There was no significant difference in comparison on each day among the Protèque, vehicle, and SLS only test sites.

2) Transepidermal water loss (TEWL) on Protèque pretreated testing site was significantly decreased in comparison to SLS only treated site, and also in comparison to placebo control pretreated testing site on day 2, 4 and 5.