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A 6-Week Study to Evaluate the Photoallergic Potential of Diacerein 1% Ointment in Healthy Volunteers

NCT03473197 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2020-02-05

Study results available
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Summary

A study in healthy male and female adult volunteers to determine the potential of diacerein 1% ointment to induce a photoallergic skin reaction using a controlled photopatch testing procedure.

Conditions

  • Healthy

Interventions

DRUG

Diacerein 1% ointment

During the 3-week Induction Phase, diacerein 1% ointment and vehicle ointment were applied under fully occlusive patch conditions to two randomly assigned skin sites on the infrascapular region of the back twice each week for approximately 24 hours (±4 hours). After patch removal, one application site and an untreated control site was irradiated, and all sites were evaluated 24 hours, 48 hours, and 72 hours later. Following a rest period, during the Challenge Phase, the study products were applied to two naive sites once for approximately 24 hours (±4 hours). After patch removal, one application site and an untreated control site was irradiated, and all sites were evaluated 24 hours, 48 hours, and 72 hours later. A Re-Challenge was to be performed if a response observed during the Challenge Phase indicated photosensitization.

Sponsors & Collaborators

  • Castle Creek Pharmaceuticals, LLC

    lead INDUSTRY

Principal Investigators

  • Mary Spellman, MD · Castle Creek Pharmaceuticals, LLC

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-08
Primary Completion
2018-03-09
Completion
2018-03-09
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03473197 on ClinicalTrials.gov