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Treprostinil Iontophoresis in Systemic Sclerosis Digital UlcErations. A Proof of Concept Study

NCT03120533 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2020-04-10

No results posted yet for this study

Summary

The study is conducted to confirm the good tolerance of a continuous cathodal iontophoresis of the treprostinil hydrogel administered during 10 days on the pulp of the finger of healthy volunteer and on the ischemic digital ulcerations of Systemic Sclerosis patients, particularly to estimate the cutaneous tolerance of the procedure and the effect on the blood pressure.

Conditions

  • Scleroderma, Systemic

Interventions

DRUG

Iontophoresis of treprostinil

the participant will receive 10 days of iontophoresis of treprostinil on a first site

DRUG

Iontophoresis of placebo

the participant will receive 10 days of iontophoresis of NaCl on a second site, but the same time than treprostinil; it's like a design of cross-over study

Sponsors & Collaborators

  • Linksium

    collaborator UNKNOWN

  • University Grenoble Alps

    collaborator OTHER

  • University Hospital, Grenoble

    lead OTHER

Principal Investigators

  • Jean-Luc CRACOWSKI, MD,PhD · CIC 1406

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-06-20
Primary Completion
2019-06-03
Completion
2019-06-03

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03120533 on ClinicalTrials.gov