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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

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

Who can join

Ages 16 and older · All sexes

Key Inclusion Criteria:

* Completed the PALV-05 (VAPAUS) study
* Agree to contraceptive use

Key Exclusion Criteria:

* Females who are pregnant or breastfeeding
* Concomitant use of sirolimus or any sirolimus-containing medications (systemic or topical)
* Any significant concurrent condition that could adversely affect participation and/or the assessment of the safety and efficacy in the study
* Prior or planned treatment, including surgery or other medically necessary intervention deemed by the investigator that could adversely affect participation and/or the assessment of the safety and efficacy in the study

About the study

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".

What is being tested

• PTX-022 (drug)

Sponsor: Palvella Therapeutics, Inc. · Participants: 45 · Started: Nov 15, 2022

Contact the study team

• Emily Cook · Phone: 267-738-6366

Official record on ClinicalTrials.gov — NCT05643872

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.