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
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||118 participants|
|Observational Model:||Case Control|
|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|
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.
- 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.
- 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.
- 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.
- 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.
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
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center|
|Cincinnati, Ohio, United States, 45229|
|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|