Active for Pachyonychia Congenita

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Pachyonychia Congenita+1 More
QTORIN 3.9% rapamycin anhydrous gel - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial looks at whether QTORIN 3.9% rapamycin gel is safe and effective in treating adults with Pachyonychia Congenita.

Eligible Conditions
  • Pachyonychia Congenita

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: 6 months

6 months
Clinician global impression of change (CGI-C)
Clinician global impression of severity (CGI-S)
PROMIS physical function
Pain
Patient Global Assessment of Activities Difficulty Scale
Patient global impression of change (PGI-C)
Patient global impression of severity (PGI-S)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Active
1 of 2
Vehicle
1 of 2

Active Control

Non-Treatment Group

80 Total Participants · 2 Treatment Groups

Primary Treatment: Active · Has Placebo Group · Phase 3

Active
Drug
ActiveComparator Group · 1 Intervention: QTORIN 3.9% rapamycin anhydrous gel · Intervention Types: Drug
Vehicle
Drug
PlaceboComparator Group · 1 Intervention: Vehicle · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months

Who is running the clinical trial?

Palvella Therapeutics, Inc.Lead Sponsor
4 Previous Clinical Trials
184 Total Patients Enrolled
2 Trials studying Pachyonychia Congenita
109 Patients Enrolled for Pachyonychia Congenita
Joyce Teng, MDPrincipal InvestigatorStanford University
2 Previous Clinical Trials
133 Total Patients Enrolled
1 Trials studying Pachyonychia Congenita
73 Patients Enrolled for Pachyonychia Congenita
David Hansen, MDPrincipal InvestigatorUniversity of Utah
1 Previous Clinical Trials
73 Total Patients Enrolled
1 Trials studying Pachyonychia Congenita
73 Patients Enrolled for Pachyonychia Congenita
Amy Paller, MDStudy ChairNorthwestern University
16 Previous Clinical Trials
2,622 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 19th, 2021

Last Reviewed: November 10th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.