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mTOR Inhibitor
Active for Pachyonychia Congenita (VAPAUS Trial)
Phase 3
Recruiting
Led By Joyce Teng, MD
Research Sponsored by Palvella Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
VAPAUS Trial Summary
This trial looks at whether QTORIN 3.9% rapamycin gel is safe and effective in treating adults with Pachyonychia Congenita.
Eligible Conditions
- Pachyonychia Congenita
VAPAUS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Patient Global Assessment of Activities Difficulty Scale
Secondary outcome measures
Clinician global impression of change (CGI-C)
Clinician global impression of severity (CGI-S)
PROMIS physical function
+3 moreVAPAUS Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: ActiveActive Control1 Intervention
Group II: VehiclePlacebo Group1 Intervention
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Who is running the clinical trial?
Palvella Therapeutics, Inc.Lead Sponsor
6 Previous Clinical Trials
279 Total Patients Enrolled
3 Trials studying Pachyonychia Congenita
154 Patients Enrolled for Pachyonychia Congenita
Amy Paller, MDStudy ChairNorthwestern University
17 Previous Clinical Trials
2,602 Total Patients Enrolled
Joyce Teng, MDPrincipal InvestigatorStanford University
2 Previous Clinical Trials
133 Total Patients Enrolled
1 Trials studying Pachyonychia Congenita
73 Patients Enrolled for Pachyonychia Congenita
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