Clinical trial NCT02035319: Effect of Laser Treatment on Capillary Malformations
Official title: Effect of Laser Treatment on Capillary Malformations Using Skin Imaging and Analysis
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Capillary Malformation
Port Wine Stain
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2014-01-14
Enrollment: 0
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The research will be conducted among up to 100 patients of the Hemangioma and Vascular Malformation Center at Cincinnati Children's Hospital Medical Center who will undergo laser treatment for capillary malformations.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in capillary malformations in response to laser treatment
timeFrame: an expected average of 6 months
Secondary outcomes:
measure: Number of patients with improvement in standard clinical evaluations compared to improvement as seen by quantitative imaging techniques in capillary malformations after laser treatment
timeFrame: an expected average of 6 months
measure: Change in imaging outcome measures
timeFrame: an expected average of 6 months
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Adrienne Hammill, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: