Ontogeny of Infantile Hemangiomas With Skin Imaging Modalities

NCT ID: NCT02061735

Last Updated: 2015-05-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 118 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2015-04-30

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).

Conditions

Infantile Hemangiomas

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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 interventions assigned to this group

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.

No interventions assigned to this group

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

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Society for Pediatric Dermatology

OTHER

Sponsor Role: collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marty O Visscher, PhD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Denise Adams, MD

Role: STUDY_CHAIR

Children's Hospital Medical Center, Cincinnati

Adrienne Hammill, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Locations

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 27062495 (View on PubMed)

Other Identifiers

CHMC 2011-0443

Identifier Type: -

Identifier Source: org_study_id