A 4-Day Study to Evaluate the Photoxicity of Diacerein 1% Topical Ointment in Healthy Volunteers

NCT03473184 | Completed Phase 1 Results FDA Drug

• 1 other identifier: CCP-020-104
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

This study was designed to assess the phototoxic potential of diacerein 1% ointment when application is followed by light exposure.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Observed Phototoxicity

  The mean of the total irritation scores 24 and 48 hours post the site irradiation procedure. ( i.e. Day 3 and 4) Total Irritation Score is a visual score summing the degree of erythema and edema. Minimum score= 0; Maximum score = 5; higher score = worse outcome.

  Days 3 and 4 (24 and 48 hours post site irradiation procedure)

Study Arms (1)

Single Cohort (Healthy Volunteers)

EXPERIMENTAL

Single cohort received diacerein 1% ointment

Drug: Diacerein 1% ointment

Interventions

Diacerein 1% ointment DRUG

Diacerein 1% ointment and vehicle ointment were applied on Day 1 at two randomly assigned skin sites on each side of the lower thoracic area of the back according to a randomization scheme. One side of the back was irradiated on Day 2, including an untreated irradiated control site, and the other side was to remain non-irradiated.

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) at Day 1 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 adverse events (AEs);
• Is of any Fitzpatrick Skin Type or race, providing the skin pigmentation will allow discernment of erythema

You may not qualify if:

• Has a history of photosensitivity or photoallergy;
• 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 taking medication known to cause phototoxic reactions (eg, tetracyclines, thiazides, nonsteroidal anti-inflammatory drugs \[NSAIDs\]);
• Has psoriasis and/or active atopic dermatitis/eczema;
• Has known sensitivity or allergy to constituents of 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 trial.

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: Phototoxicity Potential Assessment (Photopatch test). All subjects received applications of 0.2 mL of diacerein 1% ointment and vehicle ointment under occlusive patch conditions to 2 skin sites at the infrascapular area of the back for approximately 24 (±2) hours. Following the removal of the patches, one site was irradiated and one remained non-irradiated.

Study Record Dates

• First Submitted: March 5, 2018
• First Posted: March 22, 2018
• Study Start: December 12, 2017
• Primary Completion: December 15, 2017
• Study Completion: December 15, 2017
• Last Updated: February 10, 2020
• Results First Posted: February 10, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)