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

NCT03472547 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 234

Last updated 2019-10-21

Study results available
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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

Interventions

DRUG

diacerein 1% ointment

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).

Sponsors & Collaborators

  • 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
2018-01-15
Primary Completion
2018-03-03
Completion
2018-03-03
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 NCT03472547 on ClinicalTrials.gov