Optimizing Timolol Maleate Treatment of Infantile Hemangioma by Doppler Ultrasound Examination

• Conditions: Infantile Hemangioma
• Interventions: Drug: Timolol Maleate 0.5% Oph Soln

• Registration Number: NCT03842631
• Lead Sponsor: XiaoXi Lin

Brief 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. 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 Timeline

• Status Verified: 2019-02
• Study First Submitted: 2019-02-02
• Study First Submitted QC: 2019-02-13
• Study First Posted: 2019-02-15
• Study Start: 2019-02-16
• Last Update Submitted: 2019-02-16
• Last Update Posted: 2019-02-19
• Primary Completion: 2020-06-01
• Study Completion: 2020-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Superficial Group	Timolol Maleate 0.5% Oph Soln	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.
Deep Group	Timolol Maleate 0.5% Oph Soln	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.

Primary Outcome Measures

Name	Time	Method
Depth of infantile hemangioma	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.

Secondary Outcome Measures

Name	Time	Method
Dimensions	through study completion, an average of 1 year	The dimension of lesion is measured by standard photography.
Color	through study completion, an average of 1 year	The redness of lesion is measured by standard photography.

Trial Locations

Locations (1)

Shanghai Ninth People's hospital, Shanghai Jiaotong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China