Clinical trial NCT03472547: A Study of Sensitizing Potential of Diacerein 1% Ointment in Healthy Subjects
Official title: A Randomized, Controlled Study to Evaluate the Sensitizing Potential of CCP-020 (Diacerein 1%) Topical Ointment in Healthy Subjects Using a Repeat Insult Patch Test Design
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Castle Creek Pharmaceuticals, LLC
Sponsor class: INDUSTRY
First posted: 2018-03-21
Enrollment: 234
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All subjects were exposed to diacerein 1% ointment, vehicle ointment, and 0.9% saline (negative control) at 3 randomly assigned, adjacent skin sites on the infrascapular area of the back 3 times weekly for 3 weeks (9 applications) during the Induction Phase, and one time during the Challenge Phase (10 times in total).
Primary purpose: OTHER

Brief summary: Single center, randomized, controlled, evaluator blinded, within-subject study to evaluate the sensitization potential of diacerein 1% ointment under occlusive conditions on normal skin of healthy volunteer subjects.

Detailed description: The study was designed to assess the sensitization potential of diacerein 1% ointment in comparison to vehicle ointment and 0.9% saline (negative irritant control) under occlusive patch conditions, at 3 randomly assigned, adjacent skin sites, 3 times weekly for 3 weeks (9 applications) during the Induction Phase, and one time during the Challenge Phase (10 times in total) for determining sensitization potential.

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

Primary outcomes:
measure: Observed Sensitization
timeFrame: 56 days
Secondary outcomes:
Other outcomes:
Locations:
city: Fair Lawn
country: United States
facility: TKL Research
state: New Jersey
Study officials:
affiliation: Castle Creek Pharmaceuticals, LLC
name: Mary Spellman, MD
role: STUDY_CHAIR
References: