A Study of Sensitizing Potential of Diacerein 1% Ointment in Healthy Subjects
Condition: Healthy
Intervention: diacerein 1% ointment
Intervention description: All subjects were exposed to diacerein 1% ointment, vehicle ointment, and 0.9% saline (negative control) at 3 randomly assigned, adjacent skin sites on the infrascapular area of the back 3 times weekly for 3 weeks (9 applications) during the Induction Phase, and one time during the Challenge Phase (10 times in total).
Intervention MeSH terms: Diacerein
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Intervention model description: All subjects were exposed to diacerein 1% ointment, vehicle ointment, and 0.9% saline (negative control) at 3 randomly assigned, adjacent skin sites on the infrascapular area of the back 3 times weekly for 3 weeks (9 applications) during the Induction Phase, and one time during the Challenge Phase (10 times in total).
Masking: None (Open Label)
Enrollment: 234.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Single center, randomized, controlled, evaluator blinded, within-subject study to evaluate
      the sensitization potential of diacerein 1% ointment under occlusive conditions on normal
      skin of healthy volunteer subjects.
    

Eligibility criteria:

        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