Optimizing Timolol Maleate Treatment of Infantile Hemangioma by Doppler Ultrasound Examination

NCT03842631 | Unknown

• 1 other identifier: SH9H-2018-T48-2
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Infantile Hemangioma

Keywords

Timolol Maleate; Doppler Ultrasound Examination

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Color

  through study completion, an average of 1 year

• Dimensions

  through study completion, an average of 1 year

Study Arms (2)

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

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

Interventions

Timolol Maleate 0.5% Oph Soln DRUG

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

Also known as: 0.5% Timolol Maleate Drops

Deep Group; Superficial Group

Eligibility Criteria

• Age: Up to 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• XiaoXi Lin: lead

Study Sites (1)

Shanghai Ninth People's hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200011, China

RECRUITING

MeSH Terms

Conditions

Hemangioma, Capillary

Interventions

Timolol

Condition Hierarchy (Ancestors)

Hemangioma; Neoplasms, Vascular Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Thiadiazoles; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morpholines; Oxazines

Study Officials

• Xiaoxi Lin, PhD

  Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

XiaoXi Lin, PhD

CONTACT

021-23271699; linxiaoxi@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 2, 2019
• First Posted: February 15, 2019
• Study Start: February 16, 2019
• Primary Completion: June 1, 2020
• Study Completion: December 1, 2020
• Last Updated: February 19, 2019

Record last verified: 2019-02

Locations

CN (1)