NCT01572961

Brief Summary

Current stimulation induces microvascular dilation in human skin. The investigators aimed to study (1) whether the current vasodilation is amplified after two segmental current stimulation as compared to one stimulation; (2) whether this amplification relies on prostaglandin-sensitive mechanisms. A double-blind randomized placebo-controlled crossover trial is conducted in Angers, France.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2010

Typical duration for not_applicable

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

November 1, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 4, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 6, 2012

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

February 12, 2016

Status Verified

February 1, 2016

Enrollment Period

1.3 years

First QC Date

April 4, 2012

Last Update Submit

February 11, 2016

Conditions

Physiology of Microvascular Skin

Keywords

Laser Doppler flowmetry, skin, microcirculation

Outcome Measures

Primary Outcomes (1)

  • The increase of Laser Doppler Blood Flow after the second current stimulation

    1 hour

Secondary Outcomes (1)

  • The increase of Laser Doppler Blood Flow after the second current stimulation after aspirin administration

    1 hour

Study Arms (2)

Aspirin

ACTIVE COMPARATOR

Aspirin

Drug: acetylsalicilic acids (Aspirin)

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

acetylsalicilic acids (Aspirin)DRUG

single oral dose of 1g.

Also known as: Aspegic 1000mg, sanofi aventis.
Aspirin
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> or equal to 18 years old
  • Healthy subjects

You may not qualify if:

  • Aspirin allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Angers, Maine et Loire, 49933, France

Location

Related Publications (1)

  • Mahe G, Abraham P, Humeau-Heurtier A, Gascoin L, Leftheriotis G, Durand S. Evidence for a vasomotor cyclo-oxygenase dependent mechanism of sensitization at the cutaneous level. Br J Clin Pharmacol. 2015 Aug;80(2):185-92. doi: 10.1111/bcp.12623. Epub 2015 May 26.

    PMID: 25753207DERIVED

MeSH Terms

Interventions

Aspirinacetylsalicylic acid lysinate

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Guillaume Mahe, M.D., Ph.D.

    University hospital of Angers

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2012

First Posted

April 6, 2012

Study Start

November 1, 2010

Primary Completion

March 1, 2012

Study Completion

May 1, 2013

Last Updated

February 12, 2016

Record last verified: 2016-02

Locations

FR(1)