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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00911781
Other study ID # hemangioma photo study
Secondary ID
Status Completed
Phase N/A
First received May 29, 2009
Last updated February 4, 2013
Start date February 2009
Est. completion date December 2011

Study information

Verified date February 2013
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

One of the most important and unique characteristics of infantile hemangiomas is their dramatic growth during early infancy. Most hemangiomas are either absent at birth or barely evident as a small scratch or bruise-like area. A recent study emphasized how early hemangioma growth occurs. In this study by 3 months of age, hemangiomas had reached 80% of their final size, and by 5 months of age, 80% had already stopped growing. Unfortunately the average age when most infants are seen by specialists is often at 5 months of age or later, a time when most growth is already completed.

Researchers at the University of California, San Francisco, the Medical College of Wisconsin, and at the Mayo Clinic are interested in studying hemangioma growth at even earlier ages, before 3 months of age, which is before most patients are ever seen by dermatologists or other specialists. For this study are requesting that parents of children older than 3 months of age with hemangiomas send us a series of photographs of their child which demonstrates this early growth. Ideally the photographs would show your child (including the area of the hemangioma of course) at weekly or every other week intervals up until age least 3 to 6 months of age. This will probably not be difficult if the hemangioma is on the face but we would be interested in other body locations as well, if available.

We are using these photographs to analyze early hemangioma growth patterns, to see if there is a period of especially rapid growth, and to help determine if there is a specific time before which specialty referral should occur. We are interested in all sizes of hemangiomas, from small to large. Of greatest importance is that the photos be at frequent intervals (every 1 to 2 weeks is ideal) and of sufficient quality to be able to evaluate the appearance of the hemangioma.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date December 2011
Est. primary completion date May 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 3 Months to 5 Years
Eligibility Inclusion Criteria:

- Children older than 3 months of age who have or have had a diagnosis of an infantile hemangioma. The parents of these children will be able to provide us with frequent (weekly to biweekly) photographs of the patient's hemangioma(s) during the first 3-6 months of life.

- These hemangiomas must have a superficial component that can be seen. Parents must consent to the use of their child's photographs in this study.

Exclusion Criteria:

- Current age less than 3 months. Patient who do not have an infantile hemangioma (as determined by the investigators). Patients whose photographs are not of sufficient quality or frequency in order to be evaluated for this study.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective


Related Conditions & MeSH terms


Intervention

Other:
No intervention
We are only asking for photographs from parents.

Locations

Country Name City State
United States Mayo Clinic Rochester Minnesota
United States University of California, San Francisco San Francisco California

Sponsors (3)

Lead Sponsor Collaborator
University of California, San Francisco Mayo Clinic, Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

References & Publications (1)

Chang LC, Haggstrom AN, Drolet BA, Baselga E, Chamlin SL, Garzon MC, Horii KA, Lucky AW, Mancini AJ, Metry DW, Nopper AJ, Frieden IJ; Hemangioma Investigator Group. Growth characteristics of infantile hemangiomas: implications for management. Pediatrics. 2008 Aug;122(2):360-7. doi: 10.1542/peds.2007-2767. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary hemangioma growth up to 8 weeks No