Optimizing Timolol Maleate Treatment of Infantile Hemangioma by Doppler Ultrasound Examination

NCT ID: NCT03842631

Last Updated: 2019-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-16

Study Completion Date

2020-12-01

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.

Conditions

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Infantile Hemangioma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Timolol Maleate 0.5% Oph Soln

Intervention Type DRUG

External use of 0.5% Timolol Maleate Drops for all patients in different depths of IH lesion.

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.

Timolol Maleate 0.5% Oph Soln

Intervention Type DRUG

External use of 0.5% Timolol Maleate Drops for all patients in different depths of IH lesion.

Interventions

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Timolol Maleate 0.5% Oph Soln

External use of 0.5% Timolol Maleate Drops for all patients in different depths of IH lesion.

Intervention Type DRUG

Other Intervention Names

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0.5% Timolol Maleate Drops

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
Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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XiaoXi Lin

OTHER

Sponsor Role lead

Responsible Party

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XiaoXi Lin

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Xiaoxi Lin, PhD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Locations

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Shanghai Ninth People's hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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XiaoXi Lin, PhD

Role: CONTACT

021-23271699

Facility Contacts

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XiaoXi Lin, PhD

Role: primary

021-23271699

Other Identifiers

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SH9H-2018-T48-2

Identifier Type: -

Identifier Source: org_study_id

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