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Ontogeny of Infantile Hemangiomas With Skin Imaging Modalities

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ClinicalTrials.gov Identifier: NCT02061735
Recruitment Status : Completed
First Posted : February 13, 2014
Last Update Posted : May 6, 2015
Sponsor:
Collaborator:
Society for Pediatric Dermatology
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

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.

Condition or disease
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).

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Study Type : Observational
Actual Enrollment : 118 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Ontogeny and Quantitative Multimodal Skin Imaging of Infantile Hemangiomas
Study Start Date : October 2011
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine


Group/Cohort
oral propranolol
Dosage of 1 mg/kg per day divided 2 times daily. Blood pressure, heart rate and oxygen saturation are monitored after propranolol initiation. Treatment is continued with a gradual increase to 2 mg/kg per day divided 2 times daily. Treatment is continued until the hemangioma no longer changes in the characteristics judged by the physicians, including, color, size, temperature and deformability.
timolol maleate 0.5% gel
One drop of of timolol maleate 0.5% gel is topically applied and massaged into the hemangioma twice per day . This dosage provides an estimated 0.5 mg of timolol per day. The treatment is continued until it is considered to be no longer effective as judged by the physicians.
No treatment, observation only
No oral or topical treatment will be given as recommended by the treating physicians and elected by the parents. Patients will be evaluated periodically to determine what changes in treatment are warranted. If this occurs, the patients will be included in the appropriate study group.



Primary Outcome Measures :
  1. Hemangioma height [ Time Frame: up to 5 years ]
    IH height and volume will be obtained from surface scans with the Artec scanner with a 0.5 mm resolution, 0.1 mm accuracy, at 60 cm. Three dimensional scans will be created with the Artec Studio software and features quantified with the three dimensional software. Soft tissue landmarks will create the region of interest for all evaluations. Height and volume will be calculated for the infantile hemangioma versus the control.

  2. Static and Dynamic Temperature [ Time Frame: up to 5 years ]
    Temperature information will be acquired with a thermal imaging camera with analysis software. The thermal features of the surrounding uninvolved control skin are removed by applying thresholds. Static infrared thermography captures the steady-state condition and spatial distribution. Dynamic infrared thermography applies a stress (cooling) to stimulate the thermal response within the tissue.

  3. Skin color and lightness [ Time Frame: up to 5 years ]

    High resolution color Images will be taken taken with a digital camera, Micro 60 mm lens with a wireless close up flash system at 30cm and perpendicular to the site. The images are color corrected and processed into three distinct images : red color, blue-yellow color, and lightness (white - back).

    Color and thermal images are co-registered and analyzed with customized software. The system creates quantitative outputs and maps for visualization of IH regions of thermal and color activity. Threshold values for the lightness, red color, blue color and thermal images are selected based upon histogram distributions of the uninvolved skin as the values above the mean and multiple standard deviations The pixels beyond the thresholds are used to quantify and map the features due to the hemangioma itself.



Secondary Outcome Measures :
  1. Biomechanical properties [ Time Frame: up to 5 years ]
    Tissue mechanical properties (i.e., elasticity, elastic deformation, laxity, stiffness, etc.) will be measured to assess tissue deformability. The instrument measures biomechanical properties of the skin by applying a negative pressure, in the range between 20 and 500 mbar. These properies are compared to an uninvolved contralateral control site.



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Ages Eligible for Study:   1 Month to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02061735


Locations
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United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Society for Pediatric Dermatology
Investigators
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Principal Investigator: Marty O Visscher, PhD Children's Hospital Medical Center, Cincinnati
Study Chair: Denise Adams, MD Children's Hospital Medical Center, Cincinnati
Principal Investigator: Adrienne Hammill, MD, PhD Children's Hospital Medical Center, Cincinnati

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT02061735     History of Changes
Other Study ID Numbers: CHMC 2011-0443
First Posted: February 13, 2014    Key Record Dates
Last Update Posted: May 6, 2015
Last Verified: May 2015

Keywords provided by Children's Hospital Medical Center, Cincinnati:
skin imaging
image analysis
infrared thermography
infantile hemangioma
three dimensional imaging
color imaging and analysis
propranolol
timolol
ontogeny

Additional relevant MeSH terms:
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Hemangioma
Hemangioma, Capillary
Port-Wine Stain
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms
Skin Abnormalities
Congenital Abnormalities
Skin Diseases
Propranolol
Timolol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents