Optimizing Timolol Maleate Treatment of Infantile Hemangioma by Doppler Ultrasound Examination

Infantile Hemangioma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03842631
• Other study ID #: SH9H-2018-T48-2
• Status: Recruiting
• Start date: February 16, 2019
• Est. completion date: December 1, 2020

Study information

• Verified date: February 2019
• Source: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
• Contact: XiaoXi Lin, PhD
• Phone: 021-23271699
• Email: linxiaoxi[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Months

Eligibility

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

Related Conditions & MeSH terms

• Hemangioma
• Hemangioma, Capillary
• Infantile Hemangioma
• Port-Wine Stain

Intervention

Drug:
• Timolol Maleate 0.5% Oph Soln
External use of 0.5% Timolol Maleate Drops for all patients in different depths of IH lesion.

Locations

Country	Name	City	State
China	Shanghai Ninth People's hospital, Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
XiaoXi Lin

Country where clinical trial is conducted

China, 

Outcome

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