A 21 Day Irritation Study in Healthy Volunteers With Diacerein 1% Ointment

Exclusion Criteria

• •Has any visible skin disease at the application site which, in the opinion of the Investigator, will interfere with the evaluation of the test site reaction;
• •Is using systemic/topical corticosteroids within 3 weeks prior to and/or during the study, or systemic/topical antihistamines 72 hours prior to and during the study;
• •Is not willing to refrain from using systemic/topical anti-inflammatory analgesics such as aspirin, (occasional use of acetaminophen will be permitted);
• •Is using medication which, in the opinion of the Investigator, will interfere with the study results;
• •Is unwilling or unable to refrain from the use of sunscreens, cosmetics, creams, ointments, lotions or similar products on the back during the study;
• •Has psoriasis and/or active atopic dermatitis/eczema;
• •Has a known sensitivity or allergy to constituents of the materials being evaluated including diacerein, mineral oil, petrolatum, cetyl alcohol, D\&C Yellow #10 and/or ethyl paraben;
• •Has damaged skin in or around the test sites, including sunburn, excessively deep tans, uneven skin tones, tattoos, scars, excessive hair, numerous freckles, or other disfigurations of the test site;
• •Has received treatment for any type of internal cancer within 5 years prior to study entry;
• •Has any known sensitivity to adhesives; and/or
• •Has received any investigational drug(s) within 4 weeks prior to study entry