Actively Recruiting
A Study Evaluating the Safety and Pharmacokinetics of QTORIN Rapamycin 3.9% Anhydrous Gel in the Treatment of Adults With Pachyonychia Congenita
Led by Palvella Therapeutics, Inc. · Updated on 2022-12-09
45
Participants Needed
1
Research Sites
50 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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".
CONDITIONS
Official Title
A Study Evaluating the Safety and Pharmacokinetics of QTORIN Rapamycin 3.9% Anhydrous Gel in the Treatment of Adults With Pachyonychia Congenita
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Completed the PALV-05 (VAPAUS) study
- Agree to contraceptive use
- Adults aged 16 years and older
You will not qualify if you...
- Females who are pregnant or breastfeeding
- Use of sirolimus or sirolimus-containing medications (systemic or topical)
- Any significant condition that could affect participation or safety assessment
- Prior or planned treatments, including surgery or other interventions, that could affect participation or safety assessment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Minnesota Clinical Study Center
New Brighton, Minnesota, United States, 55112
Actively Recruiting
Research Team
E
Emily Cook
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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