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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03120533
• Date of registration: 23/03/2017
• Prospective Registration: Yes
• Primary sponsor: University Hospital, Grenoble
• Public title: Treprostinil Iontophoresis in Systemic Sclerosis Digital UlcErations. A Proof of Concept Study TISSUE-PoC
• Scientific title: Therapeutic Iontophoresis of Treprostinil in Systemic Sclerosis Digital UlcErations. A Proof of Concept Study
• Date of first enrolment: June 20, 2017
• Target sample size: 18
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03120533
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 1/Phase 2

Countries of recruitment

France

Contacts

• Name: Jean-Luc CRACOWSKI, MD,PhD
• Affiliation: CIC 1406

Key inclusion & exclusion criteria

Inclusion Criteria:

Healthy Volunteers:

- Age of at least 18 years

- Existence of a contraceptive method for women of child-bearing age

- Person affiliated to social security or beneficiary of such a scheme

- Signed consent form

Systemic sclerosis patients:

- Systemic sclerosis meeting the EULAR criteria.

- Presence of 1 ischemic digital cutaneous ulceration , with digital ulcer classified as
"active ulcers" according to the North American working group definition: epithelial
denudation is clearly Visible at one place and the bed of de-epithelialized ulcer can
be seen; Ulcerations distal to the proximal interphalangeal joint, not associated with
calcinosis or bony relief.

- Ulcers whose major axis measured with the electronic caliper is = 2 mm

- Age greater than or equal to 18 years

- Existence of a contraceptive method for women of reproductive age

- A person who is or is a beneficiary of social security

- Informed and signed consent signed by the patient or his / her legal representative.

Exclusion Criteria:

Healthy Volunteers

- Treprostinil contraindications: Known hypersensitivity to treprostinil or any of the
excipients, Pulmonary arterial hypertension related to veno-occlusive disease,
Congestive heart failure due to severe left ventricular dysfunction, Severe hepatic
insufficiency (Child-Pugh stage C), Evolving gastrointestinal ulcer, intracranial
hemorrhage, recent trauma or other clinical condition that may lead to bleeding,
Congenital or acquired valvular abnormalities with cardiac repercussions, Severe
ischemic heart disease or unstable angina; Myocardial infarction in the last six
months; Decompensated cardiac insufficiency not medically controlled; Severe
arrhythmias; Cerebrovascular lesions (such as transient ischemic attack, stroke) that
occurred within the last three months.

- Persons referred to in Articles L1121-5 to L1121-8 of the French Public health Code:
pregnant woman, parturient, nursing mother, person deprived of liberty by judicial or
administrative decision, person subject to a legal protection measure, can not Be
included in clinical trials.

- Subject in an exclusion period from another study,

- Subject who would receive more than 4500 euros of compensation due to his
participation in other biomedical research in the 12 months preceding this study

Systemic sclerosis patients:

- Iloprost cure carried out in the previous month or planned in the following month.

- Initiation or change of dosage of bosentan, sildenafil or calcium channel blockers in
the previous month or in the following month

- Digital Sympathectomy or botulinum toxin injection planned in the following month.

- Clinically superinfected digital ulcers

- Treprostinil contraindications: Known hypersensitivity to treprostinil or any of the
excipients, Pulmonary arterial hypertension related to veno-occlusive disease,
Congestive heart failure due to severe left ventricular dysfunction, Severe hepatic
insufficiency (Child-Pugh stage C), Evolving gastrointestinal ulcer, intracranial
hemorrhage, recent trauma or other clinical condition that may lead to bleeding,
Congenital or acquired valvular abnormalities with cardiac repercussions, Severe
ischemic heart disease or unstable angina; Myocardial infarction in the last six
months; Decompensated cardiac insufficiency not medically controlled; Severe
arrhythmias; Cerebrovascular lesions (such as transient ischemic attack, stroke) that
occurred within the last three months.

- Persons referred to in Articles L1121-5 to L1121-8 of the French Public health Code:
pregnant woman, parturient, nursing mother, person deprived of liberty by judicial or
administrative decision, person subject to a legal protection measure, can not Be
included in clinical trials.

- Subject in an exclusion period from another study,

- Subject who would receive more than 4500 euros of compensation due to his
participation in other biomedical research in the 12 months preceding this study



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Scleroderma, Systemic

Intervention(s)

Drug: Iontophoresis of treprostinil

Drug: Iontophoresis of placebo

Primary Outcome(s)

Number of side-effects graduated according to NIH CTCAE 4.03 [Time Frame: every day of iontophoresis from day 0 to day 9]

Secondary Outcome(s)

Effect of iontophoresis of treprostinil hydrogel on peri and intra ulcer flow [Time Frame: day 0 and day 9]

Systemic diffusion of the treprostinil hydrogel administered by iontophoresis [Time Frame: day 0 and day 9]

Pharmacodynamical effect of 10 days of iontophoresis of treprostinil hydrogel in systemic sclerosis patients [Time Frame: day 0 and day 9]

Pharmacodynamical effect of iontophoresis of treprostinil hydrogel in healthy volunteers on pulp finger, leg and foot [Time Frame: day 0]

Secondary ID(s)

38RC16.005

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Linksium

University Grenoble Alps