Effect of Laser Treatment on Capillary Malformations
| Status: | Withdrawn |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | Any - 17 |
| Updated: | 4/21/2016 |
| Start Date: | January 2014 |
| End Date: | June 2017 |
Effect of Laser Treatment on Capillary Malformations Using Skin Imaging and Analysis
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.
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.
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.
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 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
We found this trial at
1
site
3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
Cincinnati, Ohio 45229
1-513-636-4200
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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