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VAPAUS Phase 3 Clinical Trial for PC

November 8, 2021 by Pachyonychia

As of October 31, 2022, the trial is now fully enrolled. Results are expected summer of 2023. Thanks to all patients who are participating!

We’re pleased to announce recruitment has begun for the Palvella Phase 3 Clinical Trial for PC patients who live in the continental US and the UK. Please carefully read the information below and if you qualify and are interested in having a study site contact you with more details, fill out this form: registry.pachyonychia.org/s3/VAPAUS

Seeking Participants for Pachyonychia Congenita Clinical Research Trial

If you or someone you know has Pachyonychia Congenita (PC), you may be interested in participating in a Phase 3 clinical research trial for an experimental therapy that is applied to the soles of your feet.   

Some of the requirements for participation include:

  • Must be able to travel to sites in the United States or United Kingdom.  Travel may include driving and/or flying.
  • Must be at least 18 years of age or older    
  • Have a clinical diagnosis of PC, genetically confirmed to involve any of four keratin genes KRT6A, KRT6B, KRT6C or KRT16
    • If you have not been genetically tested, or if you do not have a copy of your genetic testing report, please contact PC Project at study@pachyonychia.org for more information about genetic testing.
      NOTE: If you know your mutation because a family member was tested, you will need to do a confirming test through PC Project, so you will have your own report.
  •  Have not been dosed with PTX-022 in the past 6 months
  • On a daily basis during the study answer questions on a smartphone-based app.

Participants must be, in the opinion of the study doctor, able to understand the study, cooperate with the study procedures and willing to return to the clinic for all of the required visits.  Your participation is voluntary.

If you qualify for study participation, you will be compensated for your time and your travel expenses to and from the clinic for both you and a companion. Clinic sites are at the following locations:

  • Portland, Oregon (Oregon Health & Science University)
  • New Brighton, Minnesota (Minnesota Clinical Research Center)
  • Orange Park, FL (Park Avenue Dermatology)
  • Austin, Texas (DermResearch, Inc.)
  • Palo Alto, CA (Stanford)
  • New Haven, CT (Yale University)
  • Salt Lake City, UT (University of Utah)
  • London, England for those in the UK

If you are interested in participating, you can either:

  • Complete https://registry.pachyonychia.org/s3/VAPAUS
    OR
  • Call PC Project at 801-987-8758 or at study@pachyonychia.org

Filed Under: Clinical Trials, News

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PACHYONYCHIA CONGENITA PROJECT

P.O. Box 17850
Holladay, UT 84117

info@pachyonychia.org

801-987-8758

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