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Clinical Trials/NCT01735734
NCT01735734UnknownNot Applicable

An Observational Study as to the Effects of Cutaneous Air-cooling on Blood Vessel Diameter in Capillary Malformations

National Health Service, United Kingdom1 site in 1 country35 target enrollmentStarted: February 2013Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
35
Locations
1
Primary Endpoint
To study the effects of cutaneous air cooling on blood vessel diameter in capillary malformation

Study Overview

Brief Summary

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

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
16 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Adult more than 16 years of age
  • Patient diagnosed with Capillary Malformation

Exclusion Criteria

  • Patients less than 16 years of age

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
National Health Service, United Kingdom
Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

Dr Irving Ling

Academic Foundation Doctor, Honorary Clinical Fellow

NHS Greater Glasgow and Clyde

Study Sites (1)

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