A Study Evaluating the Safety and Pharmacokinetics of QTORIN Rapamycin 3.9% Anhydrous Gel in the Treatment of Adults With Pachyonychia Congenita
EC
Overseen ByEmily Cook
Age: Any Age
Sex: Any
Trial Phase: Phase 3
Sponsor: Palvella Therapeutics, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Trial Summary
What is the purpose of this trial?
This trial is testing a special skin gel called QTORIN rapamycin on adults with a rare genetic skin disorder to see if it is safe and how it works.
Will I have to stop taking my current medications?
You will need to stop taking any medications that contain sirolimus, as the trial excludes participants using these drugs.
Eligibility Criteria
Inclusion Criteria
Completed the PALV-05 (VAPAUS) study
Agree to contraceptive use
Exclusion Criteria
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
Females who are pregnant or breastfeeding
Concomitant use of sirolimus or any sirolimus-containing medications (systemic or topical)
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Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive QTORIN rapamycin 3.9% anhydrous gel to evaluate safety and pharmacokinetics
Long-term
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Treatment Details
Interventions
- PTX-022
Participant Groups
1Treatment groups
Experimental Treatment
Group I: PTX-022Experimental Treatment1 Intervention
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Who Is Running the Clinical Trial?
Palvella Therapeutics, Inc.
Lead Sponsor
Trials
8
Recruited
380+
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