Effect of Laser Treatment on Capillary Malformations

Withdrawn

• Conditions: Capillary Malformation; Port Wine Stain

• Registration Number: NCT02035319
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Brief Summary

In this research study investigators want to learn more about capillary malformations which are also known as port wine stains.

Investigators are asking children with capillary malformations (port wine stains) to be in the research, because investigators do not have a good idea of what to expect from the current treatments of these malformations. These malformations are treated with laser as clinically indicated and there are no standardized methods to assess improvement.

Detailed 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. 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.

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-07
• Study First Submitted QC: 2014-01-13
• Study First Posted: 2014-01-14
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-21
• Last Update Posted: 2015-08-25
• Primary Completion: 2017-01
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in capillary malformations in response to laser treatment	an expected average of 6 months	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).

Secondary Outcome Measures

Name	Time	Method
Change in imaging outcome measures	an expected average of 6 months	digital imaging for color digital image processing thermal imaging image co-registration blood concentration biomechanical properties
Number of patients with improvement in standard clinical evaluations compared to improvement as seen by quantitative imaging techniques in capillary malformations after laser treatment	an expected average of 6 months	clinical characteristics of color clinical characteristics of temperature clinical characteristics of tissue morphology clinical characteristics of pliability clinical characteristics of hyperplasia digital imaging for color digital image processing thermal imaging image co-registration blood concentration biomechanical properties

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States