Hemangiomas of InfancyNCT00911781
Hemangioma Growth During the First 6 Months of Life
An observational study of Hemangiomas of Infancy, run by University of California, San Francisco at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 3 months to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemangiomas of Infancy
- How many people
- 36 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2009to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Patients are being recruited from a national hemangioma support website (NOVA)and from community clinics atthe University of California, San Francisco. We hope to reach more interested parents through registering our protocol.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mayo Clinic
Rochester, Minnesota, 55901
University of California, San Francisco
San Francisco, California, 94115
About this study
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.
- Conditions
- Hemangiomas of Infancy
- Being tested
- No intervention
- Keywords
- Infantile hemangioma
- Medical subject headings
- Hemangioma, Capillary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
We are only asking for photographs from parents.
| Study group | Role | What they receive |
|---|---|---|
| Infants with infantile hemangiomas | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
hemangioma growth
Measured: up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2009 (estimated)
- Study startFeb 2009
- Primary completionMay 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hemangiomas of InfancyStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Mayo Clinic, Medical College of Wisconsin
- Responsible party
- Sponsor
- Investigators
- Ilona J Frieden, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00911781
- Sponsor's protocol ID
- hemangioma photo study
- Status last verified
- Feb 2013
- First submitted
- 29 May 2009
- Last updated
- 5 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18676554
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemangioma Growth During the First 6 Months of Life
- ClinicalTrials.gov ID
- NCT00911781
- Acronym / sponsor ID
- hemangioma photo study
- Conditions
- Hemangiomas of Infancy
- Keywords
- Infantile hemangioma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Mayo Clinic, Medical College of Wisconsin
- Study start
- Feb 2009
- Primary completion
- May 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 2 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infants with infantile hemangiomas | – | Other: No intervention |
Who may qualify
- Ages
- 3 months to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Patients are being recruited from a national hemangioma support website (NOVA)and from community clinics atthe University of California, San Francisco. We hope to reach more interested parents through registering our protocol.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionWe are only asking for photographs from parents. | Other | Infants with infantile hemangiomas |
Primary outcome
hemangioma growth
Time frame: up to 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2013.
- Background: PubMed 18676554Chang 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.
- Tollefson MM, Frieden IJ. Early growth of infantile hemangiomas: what parents' photographs tell us. Pediatrics. 2012 Aug;130(2):e314-20. doi: 10.1542/peds.2011-3683. Epub 2012 Jul 23. PubMed PMID: 22826568.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ilona J Frieden, MD principal investigator
University of California, San Francisco
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemangiomas of Infancy, run by University of California, San Francisco at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hemangioma growth (time frame: up to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00911781, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2013; AzTrials last refreshed its copy on 8 Nov 2026.