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

NCT ID: NCT03473184

Last Updated: 2020-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-12
• Study Completion Date: 2017-12-15

Brief Summary

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

Detailed Description

This was a single-center, randomized, within-subject comparison of diacerein 1% ointment and vehicle ointment applied to 2 sites on opposite sides of the the infrascapular area of the back under occlusive patch conditions for approximately 24 (±2) hours. Product was applied according to the randomization scheme in an amount of 0.2 mL, once during the study.

Patches were removed and 1 of the skin sites for each product was irradiated and 1 remained non-irradiated. The irradiated and non-irradiated sites were compared with each other and with an untreated irradiated control site.

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Single Cohort (Healthy Volunteers)

Single cohort received diacerein 1% ointment

Group Type: EXPERIMENTAL

Diacerein 1% ointment

Intervention Type: 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.

Interventions

Diacerein 1% ointment

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.

Intervention Type: DRUG

Other Intervention Names

CCP-020

Eligibility Criteria

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) 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Castle Creek Pharmaceuticals, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mary Spellman, MD

Role: STUDY_CHAIR

Castle Creek Pharmaceuticals, LLC

Locations

TKL Research

Fair Lawn, New Jersey, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CCP-020-104

Identifier Type: -

Identifier Source: org_study_id