A 4-Day Study to Evaluate the Photoxicity of Diacerein 1% Topical Ointment in Healthy Volunteers (NCT03473184) | Clinical Trial Compass
CompletedPhase 1
A 4-Day Study to Evaluate the Photoxicity of Diacerein 1% Topical Ointment in Healthy Volunteers
United States34 participantsStarted 2017-12-12
Plain-language summary
This study was designed to assess the phototoxic potential of diacerein 1% ointment when application is followed by light exposure.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 materia…
What they're measuring
1
Observed Phototoxicity
Timeframe: Days 3 and 4 (24 and 48 hours post site irradiation procedure)