Study of RVT-501 Topical Ointment in Pediatric Patients With Atopic Dermatitis

NCT03394677 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2018-07-19

No results posted yet for this study

Summary

This is a multi-center, randomized, vehicle controlled, double-blind Phase 2 study in pediatric patients age 2-17 years old with mild to moderate atopic dermatitis.

Conditions

Interventions

DRUG

RVT-501 0.5% ointment

Patients will receive RVT-501 0.5% ointment twice daily (BID) for 4 weeks.

DRUG

Vehicle ointment

Placebo comparator - ointment twice daily (BID) for 4 weeks.

Sponsors & Collaborators

  • Dermavant Sciences GmbH

    lead INDUSTRY

Principal Investigators

  • James Lee, MD, PhD · Dermavant Sciences, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-25
Primary Completion
2018-07-02
Completion
2018-07-02
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

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Entities

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 NCT03394677 on ClinicalTrials.gov