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Phase 2/3 Study Evaluating the Safety and Efficacy of PTX-022 in Treatment of Adults With Pachyonychia Congenita
Not Recruiting
Trial ID: NCT03920228
Purpose
This study evaluates the safety and efficacy of PTX-022, topical rapamycin, in the treatment
of adults with moderate to severe Pachyonychia Congenita.
This study includes four-parts, and if a participant completes all parts, the participant
will have received at least 3-months of PTX-022 treatment.
Official Title
A Multicenter, Four-Part, Phase 2/3 Study Evaluating the Safety and Efficacy of PTX-022 in the Treatment of Adults With Moderate to Severe Pachyonychia Congenita
Stanford Investigator(s)
Joyce Teng, MD, PhD
Professor of Dermatology and, by courtesy, of Pediatrics
Eligibility
Inclusion Criteria:
- Adult patients, 18 years or older
- Diagnosed Pachyonychia Congenita (PC), genetically confirmed
- Moderate to Severe PC
- Able and willing to comply with all protocol-required activities
- Willing and able to provide written informed consent
Exclusion Criteria:
- Any significant concurrent condition (including involving the inferior to the ankle)
that could adversely affect participation.
- Any intentional changes in the patient's daily activities (associated with standing,
walking and keeping balance), not resulting from an improvement in the patient's
condition due to treatment.
- Patient's deemed by the investigator as unwilling or unable to remain compliant with
all tests and procedures, including adherence to study drug administration and other
protocol-required activities.
Intervention(s):
drug: PTX-022
drug: Placebo
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Karima
650-723-0636