A 21 Day Irritation Study in Healthy Volunteers With Diacerein 1% Ointment (NCT03472534) | Clinical Trial Compass
CompletedPhase 1
A 21 Day Irritation Study in Healthy Volunteers With Diacerein 1% Ointment
United States46 participantsStarted 2018-01-09
Plain-language summary
Single center, randomized, controlled, evaluator blinded, within-subject study to evaluate the irritation potential of diacerein1% ointment on normal skin of healthy volunteers, using a cumulative irritancy patch test (CIPT) procedure.
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) 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…