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mTOR Inhibitor
A Study Evaluating the Safety and Pharmacokinetics of QTORIN Rapamycin 3.9% Anhydrous Gel in the Treatment of Adults With Pachyonychia Congenita
Phase 3
Recruiting
Research Sponsored by Palvella Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up prior to dose, 12 hours and 24 hours
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
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.
Eligible Conditions
- Pachyonychia Congenita
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ prior to dose, 12 hours and 24 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~prior to dose, 12 hours and 24 hours
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Pharmacokinetic parameters
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
1Treatment groups
Experimental Treatment
Group I: PTX-022Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PTX-022
2019
Completed Phase 3
~200
Find a Location
Who is running the clinical trial?
Palvella Therapeutics, Inc.Lead Sponsor
7 Previous Clinical Trials
336 Total Patients Enrolled
3 Trials studying Pachyonychia Congenita
196 Patients Enrolled for Pachyonychia Congenita
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a medical condition that could make it difficult for you to participate in the study or could affect how the study results are interpreted.
Research Study Groups:
This trial has the following groups:- Group 1: PTX-022
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.