A 21 Day Irritation Study in Healthy Volunteers With Diacerein 1% Ointment

Phase 1

Completed

Brief 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.

Detailed Description: This study was designed to assess the cumulative irritation potential of diacerein 1% ointment in comparison with vehicle ointment, 0.2% sodium lauryl sulfate (SLS) (positive control), and 0.9% saline (negative control) on normal skin of healthy volunteers using a cumulative irritancy patch test (CIPT) procedure applied once daily for 21 days.

Recruitment & Eligibility

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/eczema;
Has 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 drug(s) within 4 weeks prior to study entry

Arm && Interventions

Group	Intervention	Description
study in healthy volunteers	diacerein 1% ointment	diacerein 1% ointment

Primary Outcome Measures

Name	Time	Method
Skin Irritation Score	Daily for 21 days	Evaluation of the sum of all subjects' cumulative irritation scores for 21 days at each patch site. Cumulative Irritation Score is a visual score rating the degree of erythema, edema, and other signs of cutaneous irritation: Minimum = 0; Maximum = 6; higher score is worse outcome.

Secondary Outcome Measures