Optimizing Timolol Maleate Treatment of Infantile Hemangioma by Doppler Ultrasound Examination

XiaoXi Lin

Status: Unknown

Conditions: Infantile Hemangioma

Treatments: Drug: Timolol Maleate 0.5% Oph Soln

Study type: Observational

Funder types: Other

Identifiers

NCT03842631

SH9H-2018-T48-2

Details and patient eligibility

About

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.

Full description

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

Enrollment: 150 estimated patients

Sex: All

Ages: Under 6 months old

Volunteers: No Healthy Volunteers

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

Trial design

150 participants in 2 patient groups

Superficial Group

Description:

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.

Treatment:

Drug: Timolol Maleate 0.5% Oph Soln

Deep Group

Description:

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.

Treatment:

Drug: Timolol Maleate 0.5% Oph Soln