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Different Application Rates of Crisaborole Ointment 2% in Adults With Mild to Moderate Atopic Dermatitis

NCT03868098 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2021-08-24

No results posted yet for this study

Summary

This study is being conducted to evaluate the efficacy and safety of 3 different application rates of topically applied Crisaborole ointment 2% over vehicle in adults with mild to moderate atopic dermatitis (AD). In each subject four application areas will be identified. Each subject will receive 4 treatments: the 3 different application rates of the active treatment and the vehicle. The areas will be randomly assigned to treatment with topical Crisaborole ointment 2% and vehicle, once daily, for 2 weeks, without occlusion.

Conditions

  • Dermatitis, Atopic

Interventions

DRUG

Crisaborole 2%

Crisaborole ointment 2% (application rate A, B, C) for 15 days (double blind)

DRUG

Placebo ointment

Placebo ointment (vehicle)

Sponsors & Collaborators

  • Innovaderm Research Inc.

    lead OTHER

Principal Investigators

  • Robert Bissonnette, MD · Medical Director

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-21
Primary Completion
2020-11-25
Completion
2020-11-25

Countries

  • Canada

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 NCT03868098 on ClinicalTrials.gov