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

• Status: Completed
• Trial end date: 2018-01-30
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: Castle Creek Pharmaceuticals, LLC
• Collaborator: TKL Research, Inc.
• 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) 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