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Timolol Maleate Gel for the Treatment of Infantile Hemangioma

NCT06677853 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2024-11-07

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate the safety and efficacy of timolol maleate (TM) gel in subjects with superficial infantile hemangioma (IH) in the proliferative phase. The main question it aims to answer is:

• The primary endpoint (success or failure) assessment was a centralized and independent qualitative assessment based on blinded comparison on B-ultrasonography results and photographs of IH at W24 from baseline.

Researchers will compare TM gel to a placebo (a look-alike substance that contains no drug) to see if TM gel works to treat IH.

Participants will:

* Take the study drug 3 times daily (once in the morning, noon, and evening, respectively) for 24 weeks.
* The family members of patients are instructed to bring the patients to the clinic for regular follow-up visits at Week 4 (W4), Week 12 (W12), and Week 24 (W24) of the treatment period.
* Keep a diary of concomitant medications and adverse events.

Conditions

  • Infantile Hemangioma

Interventions

DRUG

Timolol Maleate Gel+Placebo

Subjects were applied with the 0.5% timolol maleate gel at the affected area twice a day, and with the placebo once a day for 24 weeks.

DRUG

Timolol Maleate Gel

Subjects were applied with the 0.5% timolol maleate gel at the affected area 3 times a day for 24 weeks.

DRUG

Placebo

Subjects were applied with placebo at the affected area 3 times a day for 24 weeks.

Sponsors & Collaborators

  • Auson Pharmaceuticals Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
35 Days
Max Age
150 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-28
Primary Completion
2022-06-21
Completion
2022-06-21

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06677853 on ClinicalTrials.gov