Physiology of Microvascular SkinMICROTECNCT01572961
Microvascular Function Assessment in Healthy Subjects
A study testing acetylsalicilic acids (Aspirin) in people with Physiology of Microvascular Skin, run by University Hospital, Angers at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Physiology of Microvascular Skin
- What is being tested?
- acetylsalicilic acids (Aspirin)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2010to May 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age > or equal to 18 years old
- Healthy subjects
Who cannot join
- Aspirin allergy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Amélioration Des Techniques d'étude de la Micro-cirulation cutanée Chez Des Sujets Sains
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.
- Conditions
- Physiology of Microvascular Skin
- Being tested
- acetylsalicilic acids (Aspirin), Placebo
- Keywords
- Laser Doppler flowmetry, skin, microcirculation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acetylsalicilic acids (Aspirin)Drug
Also called Aspegic 1000mg, sanofi aventis.
single oral dose of 1g.
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Aspirin | Active comparator | Aspirin Receives: Drug: acetylsalicilic acids (Aspirin) |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The increase of Laser Doppler Blood Flow after the second current stimulation
Measured: 1 hour
Secondary outcomes (1)
The increase of Laser Doppler Blood Flow after the second current stimulation after aspirin administration
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2012 (estimated)
- Study startNov 2010
- Primary completionMar 2012
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physiology of Microvascular SkinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Guillaume Mahe, M.D., Ph.D., Principal investigator, University hospital of Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01572961
- Sponsor's protocol ID
- 2010-10
- Acronym
- MICROTEC
- Status last verified
- Feb 2016
- First submitted
- 4 Apr 2012
- Last updated
- 12 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25753207
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amélioration Des Techniques d'étude de la Micro-cirulation cutanée Chez Des Sujets Sains
- ClinicalTrials.gov ID
- NCT01572961
- Acronym / sponsor ID
- MICROTEC / 2010-10
- Conditions
- Physiology of Microvascular Skin
- Keywords
- Laser Doppler flowmetry, skin, microcirculation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Nov 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 6 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aspirin | Active comparator | Drug: acetylsalicilic acids (Aspirin)Aspirin |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age > or equal to 18 years old
- Healthy subjects
Key exclusion criteria (1 listed)
- Aspirin allergy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acetylsalicilic acids (Aspirin)Also: Aspegic 1000mg, sanofi aventis.single oral dose of 1g. | Drug | Aspirin |
| Placebo | Drug | Placebo |
Primary outcome
The increase of Laser Doppler Blood Flow after the second current stimulation
Time frame: 1 hour
1 secondary outcome
The increase of Laser Doppler Blood Flow after the second current stimulation after aspirin administration
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2016.
- Derived from this study: PubMed 25753207Mahe 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillaume Mahe, M.D., Ph.D. principal investigator
University hospital of Angers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acetylsalicilic acids (Aspirin) in people with Physiology of Microvascular Skin, run by University Hospital, Angers at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The increase of Laser Doppler Blood Flow after the second current stimulation (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01572961, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2016.