A 6-Week Study to Evaluate the Photoallergic Potential of Diacerein 1% Ointment in Healthy Volunteers
Condition: Healthy
Intervention: Diacerein 1% ointment
Intervention description: During the 3-week Induction Phase, diacerein 1% ointment and vehicle ointment were applied under fully occlusive patch conditions to two randomly assigned skin sites on the infrascapular region of the back twice each week for approximately 24 hours (±4 hours). After patch removal, one application site and an untreated control site was irradiated, and all sites were evaluated 24 hours, 48 hours, and 72 hours later. Following a rest period, during the Challenge Phase, the study products were applied to two naive sites once for approximately 24 hours (±4 hours). After patch removal, one application site and an untreated control site was irradiated, and all sites were evaluated 24 hours, 48 hours, and 72 hours later. A Re-Challenge was to be performed if a response observed during the Challenge Phase indicated photosensitization.
Intervention MeSH terms: Diacerein
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      A study in healthy male and female adult volunteers to determine the potential of diacerein
      1% ointment to induce a photoallergic skin reaction using a controlled photopatch testing
      procedure.
    

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 an acceptable form of
             birth control;

          -  In the case of a female of childbearing potential, has a negative urine pregnancy test
             (UPT) at Day 1 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 a history of photosensitivity or photoallergy;

          -  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);

          -  Are taking medication known to cause phototoxic reactions (eg, tetracyclines,
             thiazides, nonsteroidal anti-inflammatory drugs [NSAIDS]);

          -  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;

          -  Had 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 drugs(s) with 4 weeks prior to study entry