A 4-Day Study to Evaluate the Photoxicity of Diacerein 1% Topical Ointment in Healthy Volunteers

• Status: Completed
• Trial end date: 2017-12-15
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Castle Creek Pharmaceuticals, LLC
• Treatments: Diacetylrhein

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