- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02061735
Ontogeny of Infantile Hemangiomas With Skin Imaging Modalities
Ontogeny and Quantitative Multimodal Skin Imaging of Infantile Hemangiomas
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ohio
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Cincinnati, Ohio, United States, 45229
- Cincinnati Children's Hospital Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hemangioma height
Time Frame: up to 5 years
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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.
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up to 5 years
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Static and Dynamic Temperature
Time Frame: up to 5 years
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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.
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up to 5 years
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Skin color and lightness
Time Frame: up to 5 years
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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. |
up to 5 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Biomechanical properties
Time Frame: up to 5 years
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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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up to 5 years
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Marty O Visscher, PhD, Children's Hospital Medical Center, Cincinnati
- Principal Investigator: Adrienne Hammill, MD, PhD, Children's Hospital Medical Center, Cincinnati
- Study Chair: Denise Adams, MD, Children's Hospital Medical Center, Cincinnati
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHMC 2011-0443
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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