Infantile HemangiomaNCT03842631
Optimizing Timolol Maleate Treatment of Infantile Hemangioma by Doppler Ultrasound Examination
An observational study of Infantile Hemangioma, run by XiaoXi Lin at 1 site in China.
Trial summary
The purpose of this study is to assess the safety and efficacy of Timolol Maleate treatment for different depth of infantile hemangioma based on B-ultrasonography. Based on the depth of hemangioma, patients will be proactively allocated to two groups. Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Infantile Hemangioma
- What is being tested?
- Timolol Maleate 0.5% Oph Soln
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 16 Feb 2019to 1 Dec 2020
- 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 6 months
- All sexes
- No healthy volunteers
- Child
Study population: Patients with infantile hemangiomas presented to the outpatient clinic of Shanghai Ninth People's Hospital would be considered for enrolment in the study. The diagnosis of proliferating infantile hemangioma is based on medical history and B-ultrasonography.
Who may be able to join
- Infants of 0 to 6 months of age
- Skin Infantile hemangiomas (IHs) in the proliferation stage without prior treatment
- IHs with a surface area of less than 1% of body surface area
- Skin type III/IV
Who cannot join
- Ulcerated IHs.
- Unsuitable for topical Timolol treatment due to anatomical location of lesion, eg.
- periorbital and lip IHs.
- Patients with severe systemic or congenital disease which may affect the patient's safety in this study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Ninth People's hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200011
XiaoXi Lin, PhD, 021-23271699, linxiaoxi@126.com
About this study
Official title: Optimizing Timolol Maleate Treatment of Infantile Hemangioma by Doppler Ultrasound Examination: a Single Center, Open Cohort Study.
The purpose of this study is to assess the safety and efficacy of Timolol Maleate treatment for different depth of infantile hemangioma based on B-ultrasonography. Based on the depth of hemangioma, patients will be proactively allocated to two groups. And then, all patients in both groups will receive topical timolol treatment in the same protocol and dosage.
Read the detailed description
Primary: Describe the efficacy of 0.5% topical timolol maleate drops in different depth of infantile hemangioma as assessed through IB-ultrasound.
- Conditions
- Infantile Hemangioma
- Being tested
- Timolol Maleate 0.5% Oph Soln
- Keywords
- Timolol Maleate, Doppler Ultrasound Examination
- Medical subject headings
- Hemangioma, Capillary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Timolol Maleate 0.5% Oph SolnDrug
Also called 0.5% Timolol Maleate Drops
External use of 0.5% Timolol Maleate Drops for all patients in different depths of IH lesion.
| Study group | Role | What they receive |
|---|---|---|
| Superficial Group | Hemangioma depth evaluated by B-ultrasonoscope is lower than or equal to 6mm. After enrollment, patients would be subject to external use of Timolol Maleate 0.5% Oph Soln for the treatment of hemangioma. Receives: Drug: Timolol Maleate 0.5% Oph Soln | |
| Deep Group | Hemangioma depth evaluated by B-ultrasonoscope is more than 6mm. After enrollment, patients would be subject to external use of Timolol Maleate 0.5% Oph Soln for the treatment of hemangioma. Receives: Drug: Timolol Maleate 0.5% Oph Soln |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depth of infantile hemangioma
At the beginning of treatment, the thickness of hemangioma was measured by b-mode ultrasound at each follow-up.
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
Color
The redness of lesion is measured by standard photography.
Measured: through study completion, an average of 1 year
Dimensions
The dimension of lesion is measured by standard photography.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start16 Feb 2019
- Primary completion1 Jun 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infantile HemangiomaStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- XiaoXi Lin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, XiaoXi Lin, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Investigators
- Xiaoxi Lin, PhD, Principal investigator, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03842631
- Sponsor's protocol ID
- SH9H-2018-T48-2
- Status last verified
- Feb 2019
- First submitted
- 2 Feb 2019
- Last updated
- 19 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Timolol Maleate Treatment of Infantile Hemangioma by Doppler Ultrasound Examination: a Single Center, Open Cohort Study.
- ClinicalTrials.gov ID
- NCT03842631
- Acronym / sponsor ID
- SH9H-2018-T48-2
- Conditions
- Infantile Hemangioma
- Keywords
- Timolol Maleate, Doppler Ultrasound Examination
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- XiaoXi LinUniversity, hospital or other
- Study start
- 16 Feb 2019 (actual)
- Primary completion
- 1 Jun 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 15 Feb 2019 (actual)
- 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.
The purpose of this study is to assess the safety and efficacy of Timolol Maleate treatment for different depth of infantile hemangioma based on B-ultrasonography. Based on the depth of hemangioma, patients will be proactively allocated to two groups. And then, all patients in both groups will receive topical timolol treatment in the same protocol and dosage.
Detailed description
Primary: Describe the efficacy of 0.5% topical timolol maleate drops in different depth of infantile hemangioma as assessed through IB-ultrasound.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Superficial Group | – | Drug: Timolol Maleate 0.5% Oph SolnHemangioma depth evaluated by B-ultrasonoscope is lower than or equal to 6mm. After enrollment, patients would be subject to external use of Timolol Maleate 0.5% Oph Soln for the treatment of hemangioma. |
| Deep Group | – | Drug: Timolol Maleate 0.5% Oph SolnHemangioma depth evaluated by B-ultrasonoscope is more than 6mm. After enrollment, patients would be subject to external use of Timolol Maleate 0.5% Oph Soln for the treatment of hemangioma. |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients with infantile hemangiomas presented to the outpatient clinic of Shanghai Ninth People's Hospital would be considered for enrolment in the study. The diagnosis of proliferating infantile hemangioma is based on medical history and B-ultrasonography.
Key inclusion criteria (4 listed)
- Infants of 0 to 6 months of age
- Skin Infantile hemangiomas (IHs) in the proliferation stage without prior treatment
- IHs with a surface area of less than 1% of body surface area
- Skin type III/IV
Key exclusion criteria (4 listed)
- Ulcerated IHs.
- Unsuitable for topical Timolol treatment due to anatomical location of lesion, eg.
- periorbital and lip IHs.
- Patients with severe systemic or congenital disease which may affect the patient's safety in 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 |
|---|---|---|
| Timolol Maleate 0.5% Oph SolnAlso: 0.5% Timolol Maleate DropsExternal use of 0.5% Timolol Maleate Drops for all patients in different depths of IH lesion. | Drug | Deep Group, Superficial Group |
Primary outcome
Depth of infantile hemangioma
Time frame: through study completion, an average of 1 year
At the beginning of treatment, the thickness of hemangioma was measured by b-mode ultrasound at each follow-up.
2 secondary outcomes
Color
Time frame: through study completion, an average of 1 year
Dimensions
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Infantile Hemangioma
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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.
Xiaoxi Lin, PhD principal investigator
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infantile Hemangioma, run by XiaoXi Lin at 1 site in China.
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 4 inclusion and 4 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 19 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact XiaoXi Lin, PhD (021-23271699, linxiaoxi@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depth of infantile hemangioma (time frame: through study completion, an average of 1 year). 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 19 Feb 2019.