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Open-Label Study of RVT-501 Topical Ointment in Pediatric Patients With 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
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights
No Placebo-Only Group
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
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 28 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Frequency and severity of adverse events (local and systemic)
Laboratory values
Plasma concentrations of M11 metabolite
+2 moreSecondary study objectives
Efficacy - 2-point improvement in IGA
Efficacy - Body Surface Area (BSA)
Efficacy - EASI-50
+6 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.
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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