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

Launched by PALVELLA THERAPEUTICS, INC. · Dec 1, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new gel called QTORIN rapamycin 3.9% for treating adults with a rare genetic skin condition called Pachyonychia Congenita (PC). The trial aims to find out how safe this gel is for long-term use and how the body processes it. To participate, adults must have previously taken part in another related study (called PALV-05) and agree to use contraceptives during the trial. Unfortunately, pregnant or breastfeeding women cannot join, nor can those using certain other medications related to the treatment.

If you qualify and decide to participate, you can expect to use the gel over a set period while the researchers monitor your health and any side effects. The trial is currently recruiting participants of all genders aged between 18 and 65. This study is an important step in understanding how effective and safe this treatment can be for people living with Pachyonychia Congenita.

Gender

ALL

Eligibility criteria

• 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