Phase 2/3 Study Evaluating the Safety and Efficacy of PTX-022 in Treatment of Adults With Pachyonychia Congenita

Trial ID or NCT#

NCT03920228

Status

not recruiting iconNOT RECRUITING

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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.
View All Criteria
Show Less

Investigator(s)

Joyce Teng, MD, PhD
Joyce Teng, MD, PhD
Dermatologist, Pediatric dermatologist
Professor of Dermatology and, by courtesy, of Pediatrics

Contact us to find out if this trial is right for you.

Contact

Karima
650-723-0636

View on ClinicalTrials.gov