A Study of Sensitizing Potential of Diacerein 1% Ointment in Healthy Subjects

September 26, 2019 updated by: Castle Creek Pharmaceuticals, LLC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

234

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New Jersey
      • Fair Lawn, New Jersey, United States, 07410
        • TKL Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single cohort (Healthy Volunteers)
diacerein 1% ointment
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).
Other Names:
  • CCP-020

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Observed Sensitization
Time Frame: 56 days

The determination of dermal sensitization potential was based on the recurrence of a cutaneous response at re-challenge that was equivalent or more severe than the cumulative irritation score observed during the challenge period.

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.

56 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Mary Spellman, MD, Castle Creek Pharmaceuticals, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2018

Primary Completion (Actual)

March 3, 2018

Study Completion (Actual)

March 3, 2018

Study Registration Dates

First Submitted

January 30, 2018

First Submitted That Met QC Criteria

March 14, 2018

First Posted (Actual)

March 21, 2018

Study Record Updates

Last Update Posted (Actual)

October 21, 2019

Last Update Submitted That Met QC Criteria

September 26, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCP-020-103

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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