Effect of Laser Treatment on Capillary Malformations

Status Withdrawn

Clinical Trial 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.

Clinical Trial 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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02035319
Study type	Observational
Source	Children's Hospital Medical Center, Cincinnati
Contact
Status	Withdrawn
Phase	N/A
Start date	January 2014
Completion date	June 2017

View Details

See also
Status	Clinical Trial	Phase
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Terminated	`NCT00782483` - Personalized Interactive Laser Therapy of Port Wine Stain	N/A
Completed	`NCT03948997` - The Role of Angiogenesis-related Pathways in the Development of Port Wine Stains	N/A
Completed	`NCT01364857` - French National Cohort of Children With Port Wine Stain	N/A
Withdrawn	`NCT00969397` - Combined Use of Pulsed Dye Laser and Topical Antiangiogenic Agents for Treatment of Port Wine Stain Birthmarks	Phase 1/Phase 2
Completed	`NCT00800722` - A Randomized Trial to Study Combined Pulsed Dye Laser and Rapamycin Treatment of Port Wine Stain Birthmarks.	Phase 1
Completed	`NCT00585247` - Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks	N/A
Active, not recruiting	`NCT00247299` - Evaluation and Optimization of the Technical and Clinical Performance of the Lumenis ONE Platform	N/A
Completed	`NCT00580736` - Optical Clearing of the Skin in Conjunction With Laser Treatments	Phase 1
Completed	`NCT00540566` - Optical Biopsy of Human Skin in Conjunction With Laser Treatment
Withdrawn	`NCT01166919` - Pilot Study on the Use of the Matrix Radiofrequencyfor Treatment of Port Wine Stain Birthmarks	Phase 1
Completed	`NCT00830466` - A Randomized Trial to Study Combined Pulsed Dye Laser and Rapamycin Treatment of Port Wine Stain Birthmarks.	Phase 1
Completed	`NCT00540371` - Dynamic Epidermal Cooling During Pulsed Dye Laser Treatment of Port Wine Stain Birthmark at High Fluences
Completed	`NCT01333553` - Monitoring the Response of Port Wine Stain Birthmarks to Laser Therapy With Wide-field Functional Imaging Technologies
Withdrawn	`NCT00580944` - Combined Alexandrite and Pulsed Dye Laser Treatment of Port Wine Stain Birthmarks	Phase 1

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.