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Phase 2/3 Study Evaluating the Safety and Efficacy of PTX-022 in Treatment of Adults With Pachyonychia Congenita

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Contents

clinicaltrials.gov/study/NCT03920228
Is a
‌
Clinical study
0

Clinical Study attributes

NCT Number
NCT039202280
Health Conditions in Trial
‌
Pachyonychia congenita
0
Trial Recruitment Size
730
Trial Sponsor
Palvella Therapeutics, Inc.
Palvella Therapeutics, Inc.
0
Clinical Trial Start Date
April 1, 2019
0
Primary Completion Date
2020
0
Study Completion Date
2020
0
Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Treatment0
Intervention Type
Drug0
Intervention Name
PTX-0220
Placebo0
Interventional Trial Phase
Phase 30
Phase 20
Participating Facility
Northwestern University
Northwestern University
0
Arizona Research Center
Arizona Research Center
0
Stanford University
Stanford University
0
University of Utah
University of Utah
0
Yale University
Yale University
0
Official Name
A Multicenter, Four-Part, Phase 2/3 Study Evaluating the Safety and Efficacy of PTX-022 in the Treatment of Adults With Moderate to Severe Pachyonychia Congenita0
Last Updated
August 19, 2020
0
Allocation Type
Randomized0
Intervention Model
Sequential Assignment0
Masking Type
Double0
Masked Party
Investigator0
Participant0
Study summary

This study evaluates the safety and efficacy of PTX-022, topical rapamycin, in the treatment of adults with moderate to severe Pachyonychia Congenita. This study includes four-parts, and if a participant completes all parts, the participant will have received at least 3-months of PTX-022 treatment.

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