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A 21 Day Irritation Study in Healthy Volunteers With Diacerein 1% Ointment

NCT03472534 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2020-02-05

Study results available
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Summary

Single center, randomized, controlled, evaluator blinded, within-subject study to evaluate the irritation potential of diacerein1% ointment on normal skin of healthy volunteers, using a cumulative irritancy patch test (CIPT) procedure.

Conditions

  • Healthy

Interventions

DRUG

diacerein 1% ointment

diacerein 1% ointment applied to the skin of the infrascapular area of the back under occlusive patch for 21 days.

Sponsors & Collaborators

  • TKL Research, Inc.

    collaborator INDUSTRY

  • Castle Creek Pharmaceuticals, LLC

    lead INDUSTRY

Principal Investigators

  • Mary Spellman, MD · Castle Creek Pharmaceuticals, LLC

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-09
Primary Completion
2018-01-30
Completion
2018-01-30
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 NCT03472534 on ClinicalTrials.gov