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

NCT03472547 | Completed Phase 1 Results FDA Drug

• 1 other identifier: CCP-020-103
• Study Type: interventional
• Target: 234
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Observed Sensitization

  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

Study Arms (1)

Single cohort (Healthy Volunteers)

EXPERIMENTAL

diacerein 1% ointment

Drug: diacerein 1% ointment

Interventions

diacerein 1% ointment DRUG

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).

Also known as: CCP-020

Single cohort (Healthy Volunteers)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Castle Creek Pharmaceuticals, LLC: lead

Study Sites (1)

TKL Research

Fair Lawn, New Jersey, 07410, United States

Location

MeSH Terms

Interventions

diacerein; Ointments

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Limitations and Caveats

There were no limitations or caveats in this study.

Results Point of Contact

• Title: Dr. Mary Spellman; Chief Medical Officer
• Organization: Castle Creek Pharmaceuticals, LLC

mspellman@castlecreekpharma.com

862 286 0400

Study Officials

• Mary Spellman, MD

  Castle Creek Pharmaceuticals, LLC

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: January 30, 2018
• First Posted: March 21, 2018
• Study Start: January 15, 2018
• Primary Completion: March 3, 2018
• Study Completion: March 3, 2018
• Last Updated: October 21, 2019
• Results First Posted: October 21, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)