- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02035319
Effect of Laser Treatment on Capillary Malformations
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Contacts and Locations
Study Locations
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Ohio
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Cincinnati, Ohio, United States, 45229-3039
- Cincinnati Children's Hospital Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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capillary malformation treated by laser
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in capillary malformations in response to laser treatment
Time Frame: an expected average of 6 months
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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).
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an expected average of 6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of patients with improvement in standard clinical evaluations compared to improvement as seen by quantitative imaging techniques in capillary malformations after laser treatment
Time Frame: 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
|
an expected average of 6 months
|
Change in imaging outcome measures
Time Frame: an expected average of 6 months
|
digital imaging for color digital image processing thermal imaging image co-registration blood concentration biomechanical properties
|
an expected average of 6 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Adrienne Hammill, MD, PhD, Children's Hospital Medical Center, Cincinnati
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Laser Capillary Malformation
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Port Wine Stain
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Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co...CompletedPort-wine StainChina
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University of California, IrvineBeckman Laser Institute University of California IrvineCompletedPort-wine StainUnited States
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University of California, IrvineBeckman Laser Institute University of California IrvineCompletedPORT WINE STAINUnited States
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Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co...Completed
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Centre Hospitalier Universitaire de NiceCompletedPort-wine StainsFrance
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University of Lausanne HospitalsUnknownPort-wine Stains (PWS)
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Henry VasconezGraceway Pharmaceuticals, LLCTerminated
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University of California, IrvineBeckman Laser Institute University of California IrvineCompletedPort Wine StainsUnited States
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Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co...Not yet recruitingPort-Wine Stain | Nevus Flammeus | Port-wine Birthmark