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.

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.

Study Overview

• Status: Unknown
• Conditions: Infantile Hemangioma
• Intervention / Treatment: Drug: Timolol Maleate 0.5% Oph Soln

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 Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200011
      • Recruiting
      • Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
      • Contact: XiaoXi Lin, PhD; Phone Number: 021-23271699; Email: linxiaoxi@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 6 months (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with infantile hemangiomas presented to the outpatient clinic of Shanghai Ninth People's Hospital would be considered for enrolment in the study. The diagnosis of proliferating infantile hemangioma is based on medical history and B-ultrasonography.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: Timolol Maleate 0.5% Oph Soln; External use of 0.5% Timolol Maleate Drops for all patients in different depths of IH lesion.; Other Names: 0.5% Timolol Maleate Drops
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.	Drug: Timolol Maleate 0.5% Oph Soln; External use of 0.5% Timolol Maleate Drops for all patients in different depths of IH lesion.; Other Names: 0.5% Timolol Maleate Drops

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: XiaoXi Lin
• Investigators: Principal Investigator: Xiaoxi Lin, PhD, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 16, 2019
• Primary Completion (ANTICIPATED): June 1, 2020
• Study Completion (ANTICIPATED): December 1, 2020

Study Registration Dates

• First Submitted: February 2, 2019
• First Submitted That Met QC Criteria: February 13, 2019
• First Posted (ACTUAL): February 15, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 19, 2019
• Last Update Submitted That Met QC Criteria: February 16, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Timolol Maleate; Doppler Ultrasound Examination
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Congenital Abnormalities; Skin Abnormalities; Neoplasms, Vascular Tissue; Hemangioma, Capillary; Port-Wine Stain; Hemangioma; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Enzyme Inhibitors; Timolol; Maleic acid
• Other Study ID Numbers: SH9H-2018-T48-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No