A 4-Day Study to Evaluate the Photoxicity of Diacerein 1% Topical Ointment in Healthy Volunteers
Condition: Healthy
Intervention: Diacerein 1% ointment
Intervention description: Diacerein 1% ointment and vehicle ointment were applied on Day 1 at two randomly assigned skin sites on each side of the lower thoracic area of the back according to a randomization scheme. One side of the back was irradiated on Day 2, including an untreated irradiated control site, and the other side was to remain non-irradiated.
Intervention MeSH terms: Diacerein
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Intervention model description: Phototoxicity Potential Assessment (Photopatch test). All subjects received applications of 0.2 mL of diacerein 1% ointment and vehicle ointment under occlusive patch conditions to 2 skin sites at the infrascapular area of the back for approximately 24 (±2) hours. Following the removal of the patches, one site was irradiated and one remained non-irradiated.
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study was designed to assess the phototoxic potential of diacerein 1% ointment when
      application is followed by light exposure.
    

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) 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 adverse
             events (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;

          -  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 taking medication known to cause phototoxic reactions (eg, tetracyclines,
             thiazides, nonsteroidal anti-inflammatory drugs [NSAIDs]);

          -  Has psoriasis and/or active atopic dermatitis/eczema;

          -  Has known sensitivity or allergy to constituents of 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