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

Study Overview
=================
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.

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

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: diacerein 1% ointment


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Cumulative irritancy patch test (CIPT) procedure. All subjects received once daily applications of 0.2mL of diacerein 1% ointment under occlusive patch for 21 days.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: study in healthy volunteers<br>diacerein 1% ointment | Drug: diacerein 1% ointment<br>* diacerein 1% ointment applied to the skin of the infrascapular area of the back under occlusive patch for 21 days.<br>* Other names: CCP-020;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |