NCT01082484

Brief Summary

The purpose of this study is to test whether prostacyclin analogues' cathodal iontophoresis induce a cutaneous vasodilation in healthy volunteers's forearm, without local side effects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Jan 2010

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 9, 2010

Completed
27 days until next milestone

First Posted

Study publicly available on registry

March 8, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

October 6, 2011

Status Verified

October 1, 2011

Enrollment Period

1 year

First QC Date

February 9, 2010

Last Update Submit

October 5, 2011

Conditions

Healthy

Keywords

Healthy volunteersiontophoresis

Outcome Measures

Primary Outcomes (1)

  • Amplitude of forearm cutaneous vasodilatation assessed using laser Doppler imaging

    24 hours

Secondary Outcomes (1)

  • Local tolerance assessed clinically

    Day 0 and after 7 days

Study Arms (3)

Treprostinil

EXPERIMENTAL

Treprostinil iontophoresis (250, 25 and 2.5 microM)

Drug: treprostinil

Iloprost

EXPERIMENTAL

Iloprost iontophoresis (200, 20 and 2 microM)

Drug: iloprost

NaCl 0.9%

PLACEBO COMPARATOR
Drug: NaCl 0.9%

Interventions

treprostinilDRUG

Cutaneous iontophoresis at 20 microA/ 100 microA during 20 min

Treprostinil
iloprostDRUG

Cutaneous iontophoresis at 20 microA/ 100 microA during 20 min

Iloprost
NaCl 0.9%DRUG

Cutaneous iontophoresis at 20 microA/ 100 microA during 20 min

NaCl 0.9%

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy volunteers
  • age above 18

You may not qualify if:

  • any chronic disease
  • any drug intake

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unité de Pharmacologie Clinique, Inserm CIC3, CHU Grenoble

Grenoble, 38043, France

Location

Related Publications (1)

  • Blaise S, Roustit M, Hellmann M, Millet C, Cracowski JL. Cathodal iontophoresis of treprostinil induces a sustained increase in cutaneous blood flux in healthy volunteers. J Clin Pharmacol. 2013 Jan;53(1):58-66. doi: 10.1177/0091270011434352. Epub 2013 Jan 24.

    PMID: 23400744DERIVED

MeSH Terms

Interventions

treprostinilIloprostSodium Chloride

Intervention Hierarchy (Ancestors)

Prostaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological FactorsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2010

First Posted

March 8, 2010

Study Start

January 1, 2010

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

October 6, 2011

Record last verified: 2011-10

Locations

FR(1)