Effect of Laser Treatment on Capillary Malformations

NCT02035319 | Withdrawn

• 1 other identifier: Laser Capillary Malformation
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Capillary Malformation; Port Wine Stain

Outcome Measures

Primary Outcomes (1)

• Change in capillary malformations in response to laser treatment

  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).

  an expected average of 6 months

Secondary Outcomes (2)

• 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

• Change in imaging outcome measures

  an expected average of 6 months

Study Arms (1)

capillary malformation treated by laser

capillary malformation treated by laser

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229-3039, United States

Location

MeSH Terms

Conditions

Capillary Malformations, Congenital, 1; Port-Wine Stain

Condition Hierarchy (Ancestors)

Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Adrienne Hammill, MD, PhD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2014
• First Posted: January 14, 2014
• Study Start: January 1, 2014
• Primary Completion: January 1, 2017
• Study Completion: June 1, 2017
• Last Updated: August 25, 2015

Record last verified: 2015-08

Locations

US (1)