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A Study Evaluating the Safety and Pharmacokinetics of QTORIN Rapamycin 3.9% Anhydrous Gel in the Treatment of Adults With Pachyonychia Congenita

Pachyonychia Congenita Clinical Trial

Official title:
A Multicenter Open-Label Treatment Study Evaluating the Safety and Pharmacokinetics of QTORIN Rapamycin 3.9% Anhydrous Gel in the Treatment of Adults With Pachyonychia Congenita

Clinical Trial Summary

PALV-08 is a multicenter, open-label treatment (OLT) study enrolling adults with Pachyonychia Congenita (PC) with genotyped keratin mutations KRT6A, KRT6B, KRT6C or KRT16 who were previously enrolled in the PALV-05 (VAPAUS) trial. The purpose of this OLT study is to investigate the safety of long term exposure and pharmacokinetics (PK) of QTORIN rapamycin 3.9% anhydrous gel or "PTX-022".

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05643872
Study type Interventional
Source Palvella Therapeutics, Inc.
Contact Emily Cook
Phone 267-738-6366
Email emily.cook@palvellatx.com
Status Recruiting
Phase Phase 3
Start date November 15, 2022
Completion date November 2023
View Details
See also
  Status Clinical Trial Phase
Completed NCT02592954 - Effect of Broccoli Sprout Extract on Keratinocyte Differentiation in Normal Skin Phase 1
Active, not recruiting NCT04520750 - VALO-2: Study Evaluating the Safety and Efficacy of PTX022 in the Treatment of Adults With Pachyonychia Congenita Phase 3
Recruiting NCT05180708 - A Multicenter, Phase 3 Randomized, Double-Blind, Vehicle-Controlled Study Evaluating the Safety and Efficacy of QTORIN 3.9% Rapamycin Anhydrous Gel in the Treatment of Pachyonychia Congenita Phase 3
Recruiting NCT05956314 - Assessment of KM-001 - Safety, Tolerability, and Efficacy in Patients With PPPK1 or PC Phase 1
Not yet recruiting NCT01382511 - Simvastatin Treatment of Pachyonychia Congenita N/A
Recruiting NCT05435638 - Study Designed to Evaluate Safety and Efficacy of 1% Topical Formulation of KM-001 on Type 1 Punctate Palmoplantar Keratoderma or Pachyonychia Congenita Diseases Phase 1
Completed NCT02152007 - Topical Sirolimus for the Treatment of Pachyonychia Congenita (PC) Phase 1
Completed NCT00716014 - Study of TD101, a Small Interfering RNA (siRNA) Designed for Treatment of Pachyonychia Congenita Phase 1
Recruiting NCT02321423 - International Pachyonychia Congenita Research Registry
Active, not recruiting NCT03920228 - Phase 2/3 Study Evaluating the Safety and Efficacy of PTX-022 in Treatment of Adults With Pachyonychia Congenita Phase 2/Phase 3