Cumulative Irritation Test

Healthy, adult volunteers of either sex will be patched daily on his/her back with multiple strengths of AN2718 in 2 different topical dosage forms and an active comparator over the course of 21 consecutive days. Twenty-four hours after each application, the patches will be removed and the site evaluated using a five-point scale for irritation.

Inclusion criteria

Subjects must meet all of the following criteria for inclusion in the study.

• Healthy volunteers of either sex, at least 18 years of age or older.
• Females must be of non-childbearing potential (i.e., post-menopausal or surgically sterile [bilateral oophorectomy and/or total hysterectomy]). All females must submit to a urine pregnancy test and have a negative result at Day 1 and at the final study visit.
• Subjects may be of any skin type or race providing their degree of skin pigmentation does not interfere with making readings of skin reactions.
• Willingness to follow the study procedures and complete the study.
• Written informed consent obtained.

Exclusion criteria

• Any skin disease that would in any way confound interpretation of the study results. Atopic dermatitis/eczema, psoriasis will be excluded.
• Chronic asthma will be excluded.
• Pregnant or nursing mothers.
• A history of sensitivity to any component of any of the formulations.
• Use of chronic medications (such as antihistamines, corticosteroids, analgesics and anti-inflammatories) for one week before and during the study.