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

NCT03920228 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2024-08-29

No results posted yet for this 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.

Conditions

  • Pachyonychia Congenita

Interventions

DRUG

PTX-022

PTX-022 QTORIN

DRUG

Placebo

Placebo topical

Sponsors & Collaborators

  • Palvella Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • David Hansen, MD · University of Utah

  • Joyce Teng, MD · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-01
Primary Completion
2020-09-19
Completion
2020-10-19
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT03920228 on ClinicalTrials.gov