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Are There Gender Differences in Response to Positive and Negative Irritation Controls Used in Human Cumulative Irritation Studies?

Lisa V. Long1, Jeffrey E. Berg1, Jim Bowman2, Robert Harper3.

1Hill Top Research, St. Petersburg, Florida, USA; 2Hill Top Research, Miamiville, Ohio, USA, 3Harper & Associates, La Jolla, California, USA.

This retrospective analysis was conducted to evaluate whether males and females have similar response profiles to positive and negative controls commonly used in standard cumulative irritation studies. The positive irritant control was 0.1% sodium lauryl sulfate (SLS) and the negative control was 0.9% sodium chloride (saline). Data was compiled from a total of 31 cumulative irritation studies conducted between 1995 and 2002 from four different geographical locations (Scottsdale, Arizona, St. Petersburg, Florida, Miamiville, Ohio, and Winnipeg, Manitoba). The total population consisted of 822 healthy volunteers, age 18 to 85.

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