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

Key Inclusion Criteria: * Is a healthy male or female (to be confirmed by medical history); * Is 18 years of age or older; * In the case of a female of childbearing potential, is using two acceptable forms of birth control; * In the case of a female of childbearing potential, has a negative urine pregnancy test (UPT) on Day 1 prior to randomization and are willing to submit to a UPT at the end of study (EOS); * Is free of any systemic or dermatological disorder, which, in the opinion of the Investigator, will interfere with the study results or increase the risk of AEs; * Is of any Fitzpatrick Skin Type or race, providing the skin pigmentation will allow discernment of erythema Key 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