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".
Completed the PALV-05 (VAPAUS) study
Agree to contraceptive use
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
Single group
PTX-022
DrugQTORIN rapamycin 3.9% anhydrous gel
Treatment emergent adverse events
Pharmacokinetic parameters
AUC area under the sirolimus blood concentration-time profile
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