Recruitment

Recruitment Status
Withdrawn
Estimated Enrollment
100

Inclusion Criterias

Scheduled to undergo laser treatment of the capillary malformation
age 0-17
Able to tolerate imaging procedures
...
Scheduled to undergo laser treatment of the capillary malformation
age 0-17
Able to tolerate imaging procedures
Diagnosis of a capillary malformation

Exclusion Criterias

Not scheduled to undergo laser treatment for capillary malformation
Not able to tolerate imaging procedures
Other vascular anomaly
Not scheduled to undergo laser treatment for capillary malformation
Not able to tolerate imaging procedures
Other vascular anomaly

Summary

Conditions
  • Capillary Malformation
  • Port Wine Stain
Type
Observational
Design
  • Observational Model: Case-Only
  • Time Perspective: Prospective

Participation Requirements

Age
Younger than 17 years
Gender
Both males and females

Description

Capillary malformations, specifically port wine stains, occur in one of every 12,000 live births (0.3% of newborns) with 90% on the face or neck. Pulsed dye laser therapy targeted at hemoglobin (i.e., 585 nm ± 5 nm) is commonly used to lessen the visual coloration and increase skin lightness. Presen...

Capillary malformations, specifically port wine stains, occur in one of every 12,000 live births (0.3% of newborns) with 90% on the face or neck. Pulsed dye laser therapy targeted at hemoglobin (i.e., 585 nm ± 5 nm) is commonly used to lessen the visual coloration and increase skin lightness. Presently, the outcomes of laser treatment are difficult to predict, in part due to the difficulty in quantifying the tissue changes with visual inspection methods. Quantitative skin imaging methods are currently being applied to measure the features and response to treatment for infantile hemangiomas. The current study proposes to apply these methods in the treatment of capillary malformations, e.g., port wine stains. The purpose is to determine (1) the effects of laser treatment on capillary malformations (using quantitative skin imaging methods and standard clinical assessment and (2) the relationships between the imaging outcomes immediately after treatment and after healing. In the within-subject design we aim to measure color, temperature, blood concentration and tissue mechanical properties for the capillary malformation relative to an un-involved site at baseline (prior to treatment), immediately following laser surgery and over time. Imaging outputs will be compared to the standard clinical evaluation in up to 100 patients from the Hemangioma and Vascular Malformation Center (HVMC) at regular intervals to determine changes over time. Skin sites will be imaged for color (size, erythema, blue color, lightness, excess erythema, uniformity), thermography, blood concentration and tissue mechanical properties (e.g., elasticity). Skin characteristics will be examined at baseline, prior to surgery, immediately following laser treatment, just prior to discharge and at 2 and 4-6 weeks following treatment. For subjects receiving multiple laser treatments, the procedures will be repeated after each surgery. Enrollment will occur over 2 years. Patients will be evaluated for a period of up to 6 months following the last surgery. We expect the research to provide objective measures to clarify the effectiveness of laser treatment and permit effective measurement of tumor response for therapeutic protocols.

Inclusion Criterias

Scheduled to undergo laser treatment of the capillary malformation
age 0-17
Able to tolerate imaging procedures
...
Scheduled to undergo laser treatment of the capillary malformation
age 0-17
Able to tolerate imaging procedures
Diagnosis of a capillary malformation

Exclusion Criterias

Not scheduled to undergo laser treatment for capillary malformation
Not able to tolerate imaging procedures
Other vascular anomaly
Not scheduled to undergo laser treatment for capillary malformation
Not able to tolerate imaging procedures
Other vascular anomaly

Locations

Cincinnati, Ohio, 45229-3039
Cincinnati, Ohio, 45229-3039

Tracking Information

NCT #
NCT02035319
Collaborators
Not Provided
Investigators
  • Principal Investigator: Adrienne Hammill, MD, PhD Children's Hospital Medical Center, Cincinnati
  • Adrienne Hammill, MD, PhD Children's Hospital Medical Center, Cincinnati