Oral Propranolol Versus Fractional Carbon Dioxide CO2 Laser Assisted Delivery of Topical Timolol for Treatment of Infantile Hemangioma

April 24, 2026 updated by: Amira Elbendary, Cairo University

Oral Propranolol Versus Fractional Carbon Dioxide CO2 Laser Assisted Delivery of Topical Timolol for Treatment of Infantile Hemangioma; A Randomized Controlled Comparative Study

To assess and compare the efficacy of systemic beta-blocker therapy with the efficacy and safety of fractional carbon dioxide laser-assisted delivery of a topical beta-blocker solution in the treatment of infantile hemangioma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11562
        • Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

, aged 1 month to 12 years

- presenting with superficial, deep, mixed, or proliferating IH.

Exclusion Criteria:

  • other cutaneous or systemic infections
  • chronic systemic diseases
  • known allergy to topical timolol maleate
  • contraindications to laser or beta-blocker therapy
  • IH involving mucosal or perimucosal sites
  • and a history of adverse reactions to laser therapy or keloid tendency.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Propranolol
oral propranolol group for treatment of infantile hemangioma
Drug: Propranolol 1
oral propranolol is given daily in a dose of 1 to 2 mgékg daily for 3 months
Experimental: Topical timolol with fractional CO2 laser treatment of infantile hemangioma
weekly session of fractional CO2 laser with topical timolol application
Device: Fractional CO2 laser with topical timolol
Weekly sessions were performed followed by application of timolol daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Improvement of global assessment score of infantile hemangioma
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2025

Primary Completion (Actual)

January 1, 2026

Study Completion (Actual)

January 1, 2026

Study Registration Dates

First Submitted

April 24, 2026

First Submitted That Met QC Criteria

April 24, 2026

First Posted (Actual)

May 1, 2026

Study Record Updates

Last Update Posted (Actual)

May 1, 2026

Last Update Submitted That Met QC Criteria

April 24, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS-443-2022

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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