HemangiomaNCT02351245
Clinical Characteristics of Lip Hemangiomas
An observational study of Hemangioma, run by Zhujiang Hospital.
Trial summary
Lip hemangiomas are at higher risk than those located in other sites. However, studies about clinical characteristics of lip hemangiomas have not been enough. The investigators want to conduct a prospective study on the clinical features of lip hemangiomas. Read more about this study
- Who is it for?
- Ages Up to 2 years
- Conditions the study is for
- Hemangioma
- What is being tested?
- observation
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to Feb 2015
- 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 Up to 2 years
- All sexes
- No healthy volunteers
- Child
Study population: All the patients of lip hemangiomas after Dr. Zhang in Dermatology Clinic of Zhujiang Hospital.
Who may be able to join
- Only lip hemangiomas visiting between June 1, 2010 and October 1, 2014 were included in this study, which was defined as any infantile hemangioma covering any part of vermilion.
Who cannot join
- Perioral hemangiomas which did not involve vermilion were excluded.
About this study
Official title: Clinical Characteristics and Complications of Infantile Hemangiomas Located in Lips
Lip hemangiomas are at higher risk than those located in other sites. However, studies about clinical characteristics of lip hemangiomas have not been enough. The investigators want to conduct a prospective study on the clinical features of lip hemangiomas.
Read the detailed description
Hemangiomas involving lip are of special concern, since they occur in a prominent location on the face and can distort lip anatomy and lead to disfunction. Infantile hemangiomas in lip had significantly higher incidence than the others. It is often difficult to decide which patient with an lip hemangioma is at higher risk.
The investigators are interested in conducting a study on the clinical features of lip hemangiomas. The investigators are collecting medical records and photos of lip hemangiomas, including demographic information, maternal process, birth, location, size and complication. Based on the data, sum up the main points of clinical characteristics and complication.
- Conditions
- Hemangioma
- Being tested
- observation
- Medical subject headings
- Hemangioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observationOther
| Study group | Role | What they receive |
|---|---|---|
| lip hemangiomas | Not described Receives: Other: observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
appearance time, location, size, complication of lip hemangiomas
Measured: up to 2 months
Secondary outcomes (2)
demographic information
Measured: up to 1 month
maternal specific events
Measured: up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2015 (estimated)
- Study startDec 2014
- Primary completionFeb 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemangiomaStudies of the same condition, open and under way.
- More trials run by Zhujiang HospitalThe 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
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Linlin Li, Zhujiang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02351245
- Sponsor's protocol ID
- IH201412
- Status last verified
- Jan 2015
- First submitted
- 19 Jan 2015
- Last updated
- 30 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Characteristics and Complications of Infantile Hemangiomas Located in Lips
- ClinicalTrials.gov ID
- NCT02351245
- Acronym / sponsor ID
- IH201412
- Conditions
- Hemangioma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Feb 2015 (estimated)
- First posted
- 30 Jan 2015 (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.
Lip hemangiomas are at higher risk than those located in other sites. However, studies about clinical characteristics of lip hemangiomas have not been enough. The investigators want to conduct a prospective study on the clinical features of lip hemangiomas.
Detailed description
Hemangiomas involving lip are of special concern, since they occur in a prominent location on the face and can distort lip anatomy and lead to disfunction. Infantile hemangiomas in lip had significantly higher incidence than the others. It is often difficult to decide which patient with an lip hemangioma is at higher risk.
The investigators are interested in conducting a study on the clinical features of lip hemangiomas. The investigators are collecting medical records and photos of lip hemangiomas, including demographic information, maternal process, birth, location, size and complication. Based on the data, sum up the main points of clinical characteristics and complication.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lip hemangiomas | – | Other: observation |
Who may qualify
- Ages
- Up to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All the patients of lip hemangiomas after Dr. Zhang in Dermatology Clinic of Zhujiang Hospital.
Key inclusion criteria (1 listed)
- Only lip hemangiomas visiting between June 1, 2010 and October 1, 2014 were included in this study, which was defined as any infantile hemangioma covering any part of vermilion.
Key exclusion criteria (1 listed)
- Perioral hemangiomas which did not involve vermilion were excluded.
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 |
|---|---|---|
| observation | Other | lip hemangiomas |
Primary outcome
appearance time, location, size, complication of lip hemangiomas
Time frame: up to 2 months
2 secondary outcomes
demographic information
Time frame: up to 1 month
maternal specific events
Time frame: up to 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemangioma, run by Zhujiang Hospital.
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 1 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: status not confirmed, as of the sponsor's last update on 30 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
appearance time, location, size, complication of lip hemangiomas (time frame: up to 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jan 2015.