Optimizing Timolol Maleate Treatment of Infantile Hemangioma by Doppler Ultrasound Examination

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03842631

Enrollment

150

Registered

2019-02-15

Start date

2019-02-16

Completion date

2020-12-01

Last updated

2019-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infantile Hemangioma

Keywords

Timolol Maleate, Doppler Ultrasound Examination

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.

Interventions

DRUGTimolol Maleate 0.5% Oph Soln

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 6 Months

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

China

Contacts

Primary ContactXiaoXi Lin, PhD

linxiaoxi@126.com021-23271699

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026