Healthy Clinical Trial
Official title:
A 21-Day, Randomized, Controlled Study to Evaluate the Skin Irritation Potential of CCP-020 (Diacerein 1%) Topical Ointment in Healthy Subjects Using a Cumulative Irritant Patch Test Design
Verified date | January 2020 |
Source | Castle Creek Pharmaceuticals, LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 46 |
Est. completion date | January 30, 2018 |
Est. primary completion date | January 30, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | TKL Research | Fair Lawn | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Castle Creek Pharmaceuticals, LLC | TKL Research, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Skin Irritation Score | 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. |
Daily for 21 days |
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