Clinical Trials Directory

Trials / Completed

CompletedNCT02061735

Ontogeny of Infantile Hemangiomas With Skin Imaging Modalities

Ontogeny and Quantitative Multimodal Skin Imaging of Infantile Hemangiomas

Status
Completed
Phase
Study type
Observational
Enrollment
118 (actual)
Sponsor
Children's Hospital Medical Center, Cincinnati · Academic / Other
Sex
All
Age
1 Month – 5 Years
Healthy volunteers
Accepted

Summary

A combined set of quantitative skin imaging methods will quantitatively describe the natural ontogeny and the response to standard treatments over time in patients with infantile hemangiomas.

Detailed description

Infantile hemangiomas (IH) are relatively common benign vascular neoplasms, which appear shortly after birth and grow rapidly in the following weeks and months. The proliferative phase involves a rapidly dividing endothelial cell proliferation. The tumors generally stabilize and then involute over time. They are usually clinically insignificant; however, a small percentage of them can be life threatening secondary to location, associated syndrome, and physical findings such as ulceration. Treatment options have included steroids, interferon, vincristine and more recently propranolol. There are few published prospective research studies on the effectiveness of these treatment options. Because of several factors, it has been difficult to objectively measure response of these lesions. The purpose is to determine (1) whether multiple quantitative skin imaging modalities can quantitatively describe the clinically relevant features of infantile hemangiomas, including color (red, blue), lightness, size (height, volume), biomechanical properties, temperature and perfusion and (2) the natural ontogeny and response to treatment over time. The treatments are oral propranolol, topical timolol and untreated (observation).

Conditions

Timeline

Start date
2011-10-01
Primary completion
2015-04-01
Completion
2015-04-01
First posted
2014-02-13
Last updated
2015-05-06

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02061735. Inclusion in this directory is not an endorsement.