Optimizing Timolol Maleate Treatment of Infantile Hemangioma by Doppler Ultrasound Examination

Study Overview
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Brief Summary
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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
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Primary: Describe the efficacy of 0.5% topical timolol maleate drops in different depth of infantile hemangioma as assessed through IB-ultrasound.

Official Title
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Optimizing Timolol Maleate Treatment of Infantile Hemangioma by Doppler Ultrasound Examination: a Single Center, Open Cohort Study.

Conditions
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Infantile Hemangioma

Intervention / Treatment
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* Drug: Timolol Maleate 0.5% Oph Soln


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Maximum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Superficial Group<br>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. | Drug: Timolol Maleate 0.5% Oph Soln<br>* External use of 0.5% Timolol Maleate Drops for all patients in different depths of IH lesion.<br>* Other names: 0.5% Timolol Maleate Drops;|
| Deep Group<br>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. | Drug: Timolol Maleate 0.5% Oph Soln<br>* External use of 0.5% Timolol Maleate Drops for all patients in different depths of IH lesion.<br>* Other names: 0.5% Timolol Maleate Drops;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depth of infantile hemangioma | At the beginning of treatment, the thickness of hemangioma was measured by b-mode ultrasound at each follow-up. | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Color | The redness of lesion is measured by standard photography. | through study completion, an average of 1 year | 
| Dimensions | The dimension of lesion is measured by standard photography. | through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Timolol Maleate, Doppler Ultrasound Examination