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.