Clinical trial NCT02061735: Ontogeny of Infantile Hemangiomas With Skin Imaging Modalities
Official title: Ontogeny and Quantitative Multimodal Skin Imaging of Infantile Hemangiomas
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infantile Hemangiomas
Keywords: skin imaging
image analysis
infrared thermography
infantile hemangioma
three dimensional imaging
color imaging and analysis
propranolol
timolol
ontogeny
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: Society for Pediatric Dermatology
First posted: 2014-02-13
Enrollment: 118
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients being seen at the the Hemangioma and Vascular Malformation Center of Cincinnati Children's Hospital Medical Center

Brief 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).

Eligibility criteria: Inclusion Criteria:

* Age ≤ 5 years of age
* Diagnosis of a cutaneous infantile hemangioma
* Diagnosis of hemangioma requiring treatment (treatment includes: propranolol or topical timolol) or diagnosis of an infantile hemangioma that will not be treated at the time of enrollment
* Able to tolerate imaging procedures

Exclusion Criteria:

* Age \> 5 years
* Non cutaneous infantile hemangioma
* Hemangioma on the lip
* Hemangioma on the eyelid
* Hemangioma located in areas whereby measurements cannot be made due to equipment limitations
* Deep hemangioma with no visible skin surface component
* Congenital hemangioma
* No available normal site for study control
* Other vascular anomaly
* Not able to tolerate imaging procedures

Primary outcomes:
measure: Hemangioma height
timeFrame: up to 5 years
measure: Static and Dynamic Temperature
timeFrame: up to 5 years
measure: Skin color and lightness
timeFrame: up to 5 years
Secondary outcomes:
measure: Biomechanical properties
timeFrame: up to 5 years
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Marty O Visscher, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital Medical Center, Cincinnati
name: Denise Adams, MD
role: STUDY_CHAIR
affiliation: Children's Hospital Medical Center, Cincinnati
name: Adrienne Hammill, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Burkes SA, Patel M, Adams DM, Hammill AM, Eaton KP, Randall Wickett R, Visscher MO. Infantile hemangioma status by dynamic infrared thermography: A preliminary study. Int J Dermatol. 2016 Oct;55(10):e522-32. doi: 10.1111/ijd.13298. Epub 2016 Apr 8.