Status:
RECRUITING
A Study Evaluating the Safety and Pharmacokinetics of QTORIN Rapamycin 3.9% Anhydrous Gel in the Treatment of Adults With Pachyonychia Congenita
Lead Sponsor:
Palvella Therapeutics, Inc.
Conditions:
Pachyonychia Congenita
Eligibility:
All Genders
16+ years
Phase:
PHASE3
Brief 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 ...
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
Key Trial Info
Start Date :
November 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2023
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT05643872
Start Date
November 15 2022
End Date
November 1 2023
Last Update
December 9 2022
Active Locations (1)
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1
Minnesota Clinical Study Center
New Brighton, Minnesota, United States, 55112