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Open-label treatment arm for Atopic Dermatitis

Phase 1
Waitlist Available
Research Sponsored by Dermavant Sciences GmbH
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male and female pediatric patients aged 2 to 11 with confirmed diagnosis of atopic dermatitis by Hanifin and Rajka criteria.
Patients with atopic dermatitis covering > 25% of the body surface area and with an Investigator Global Assessment of disease severity of 2 or greater at baseline.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights

Study Summary

This is a multicenter, open-label Phase 1b study in pediatric patients age 2-11 years old with extensive atopic dermatitis.

Eligible Conditions
  • Atopic Dermatitis

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Frequency and severity of adverse events (local and systemic)
Laboratory values
Plasma concentrations of M11 metabolite
+2 more
Secondary outcome measures
Efficacy - 2-point improvement in IGA
Efficacy - Body Surface Area (BSA)
Efficacy - EASI-50
+6 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Open-label treatment armExperimental Treatment1 Intervention
Open-label treatment arm - patients will receive RVT-501 0.5% twice daily (BID) for 4 weeks.

Find a Location

Who is running the clinical trial?

Dermavant Sciences GmbHLead Sponsor
12 Previous Clinical Trials
3,102 Total Patients Enrolled
James Lee, MD, PhDStudy ChairDermavant Sciences, Inc.
2 Previous Clinical Trials
267 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Open-Label Study of RVT-501 Topical Ointment in Pediatric Patients With Atopic Dermatitis
2018. "Open-Label Study of RVT-501 Topical Ointment in Pediatric Patients With Atopic Dermatitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03415282.
All > Seborrheic Dermatitis > Atopic Dermatitis
~3 spots leftby Apr 2025
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