Capillary MalformationNCT01735734
Assessing the Effects of Air-cooling on Capillary Malformations
An observational study of Capillary Malformation and Laser, run by National Health Service, United Kingdom at 1 site in United Kingdom.
Trial summary
The purpose of this observational study is to ascertain the effects of cutaneous air cooling on vessel diameter within Capillary Malformations (CM). Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Capillary Malformation, Laser, Skin Cooling
- What is being tested?
- Air cooling to CM site
- Type of treatment
- Medical device
- How many people
- 35 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2013to Nov 2013
- Phase
- Observational
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients with Capillary Malformation identified through our department database
Who may be able to join
- Adult more than 16 years of age
- Patient diagnosed with Capillary Malformation
Who cannot join
- Patients less than 16 years of age
Trial locations and contacts
1 site in 1 country.
Irving Ling, MBBS contact
United Kingdom1 site
Canniesburn Plastic Surgery Unit, Glasgow Royal Infirmary
Glasgow, G4 0SF
Irving Ling, MBBS
About this study
Official title: An Observational Study as to the Effects of Cutaneous Air-cooling on Blood Vessel Diameter in Capillary Malformations
The purpose of this observational study is to ascertain the effects of cutaneous air cooling on vessel diameter within Capillary Malformations (CM).
Read the detailed description
Capillary malformation (CM) is the most common vascular malformation occurring in approximately 0.3% of all newborn. The standard treatment for facial or aesthetically sensitive CM's is flashlamp Pulsed Dye Laser. Skin cooling prior to laser treatment of CMs is standard practice within our department. The effects of skin cooling on the vasculature within CMs are poorly understood. Previous studies by our department have shown that raising ambient temperature increases CM vessel size. It has been postulated that by increasing CM vessel size, it may also increase the effectiveness of treatment. We hypothesize that cooling the skin during laser treatment may cause vasconstriction of the superficial vessels within the CM. This may have an impact on treatment success.
- Conditions
- Capillary Malformation, Laser, Skin Cooling
- Being tested
- Air cooling to CM site
- Keywords
- Skin disease, Capillary Malformation, Laser therapy
- Medical subject headings
- Capillary Malformations, Congenital, 1, Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Air cooling to CM siteDevice
| Study group | Role | What they receive |
|---|---|---|
| Capillary malformation | Not described Receives: Device: Air cooling to CM site |
What is being measured
The primary outcome is the main question the study is designed to answer.
To study the effects of cutaneous air cooling on blood vessel diameter in capillary malformation
In a temperature controlled room, the participant's capillary diameter/depth and skin/core temperatures will be taken from their CM prior to cooling the skin. The patients' CM will be cooled for a duration of 1 minute. The above measurements will be repeated immediately after 1 minute of cooling.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2012 (estimated)
- Study startFeb 2013
- Primary completionNov 2013 (estimated)
- Study completionNov 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Capillary MalformationStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Health Service, United Kingdom
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr Irving Ling, NHS Greater Glasgow and Clyde
- Investigators
- Irving Ling, MBBS, Principal investigator, NHS Greater Glasgow and ClydeAdam Gilmour, MBChB, MRCS (Ed), Study chair, NHS Greater Glasgow and ClydeIain Mackay, MBChb, MRCS, FRCS (plast), Study director, NHS Greater Glasgow and Clyde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01735734
- Sponsor's protocol ID
- GN
- Status last verified
- Nov 2012
- First submitted
- 24 Nov 2012
- Last updated
- 28 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study as to the Effects of Cutaneous Air-cooling on Blood Vessel Diameter in Capillary Malformations
- ClinicalTrials.gov ID
- NCT01735734
- Acronym / sponsor ID
- GN
- Conditions
- Capillary Malformation, Laser, Skin Cooling
- Keywords
- Skin disease, Capillary Malformation, Laser therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- National Health Service, United KingdomOther government
- Study start
- Feb 2013
- Primary completion
- Nov 2013 (estimated)
- Study completion
- Nov 2013 (estimated)
- First posted
- 28 Nov 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.
The purpose of this observational study is to ascertain the effects of cutaneous air cooling on vessel diameter within Capillary Malformations (CM).
Detailed description
Capillary malformation (CM) is the most common vascular malformation occurring in approximately 0.3% of all newborn. The standard treatment for facial or aesthetically sensitive CM's is flashlamp Pulsed Dye Laser. Skin cooling prior to laser treatment of CMs is standard practice within our department. The effects of skin cooling on the vasculature within CMs are poorly understood. Previous studies by our department have shown that raising ambient temperature increases CM vessel size. It has been postulated that by increasing CM vessel size, it may also increase the effectiveness of treatment. We hypothesize that cooling the skin during laser treatment may cause vasconstriction of the superficial vessels within the CM. This may have an impact on treatment success.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Capillary malformation | – | Device: Air cooling to CM site |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with Capillary Malformation identified through our department database
Key inclusion criteria (2 listed)
- Adult more than 16 years of age
- Patient diagnosed with Capillary Malformation
Key exclusion criteria (1 listed)
- Patients less than 16 years of age
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 |
|---|---|---|
| Air cooling to CM site | Device | Capillary malformation |
Primary outcome
To study the effects of cutaneous air cooling on blood vessel diameter in capillary malformation
Time frame: 10 minutes
In a temperature controlled room, the participant's capillary diameter/depth and skin/core temperatures will be taken from their CM prior to cooling the skin. The patients' CM will be cooled for a duration of 1 minute. The above measurements will be repeated immediately after 1 minute of cooling.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2012.
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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.
Irving Ling, MBBS contact
Irving Ling, MBBS principal investigator
NHS Greater Glasgow and Clyde
Adam Gilmour, MBChB, MRCS (Ed) study chair
NHS Greater Glasgow and Clyde
Iain Mackay, MBChb, MRCS, FRCS (plast) study director
NHS Greater Glasgow and Clyde
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Capillary Malformation and Laser, run by National Health Service, United Kingdom at 1 site in United Kingdom.
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: status not confirmed, as of the sponsor's last update on 28 Nov 2012. 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 United Kingdom. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Irving Ling, MBBS (irvingling@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To study the effects of cutaneous air cooling on blood vessel diameter in capillary malformation (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Nov 2012.