NCT07560332

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 1, 2026

Completed
Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

April 24, 2026

Last Update Submit

April 24, 2026

Conditions

Infantile Hemangioma (IH)

Keywords

propranololtimololcarbon dioxide laserinfantile hemangioma

Outcome Measures

Primary Outcomes (1)

  • Improvement of global assessment score of infantile hemangioma

    3 months

Study Arms (2)

Propranolol

ACTIVE COMPARATOR

oral propranolol group for treatment of infantile hemangioma

Drug: Propranolol 1

Topical timolol with fractional CO2 laser treatment of infantile hemangioma

EXPERIMENTAL

weekly session of fractional CO2 laser with topical timolol application

Device: Fractional CO2 laser with topical timolol

Interventions

Propranolol 1DRUG

oral propranolol is given daily in a dose of 1 to 2 mgékg daily for 3 months

Propranolol
Fractional CO2 laser with topical timololDEVICE

Weekly sessions were performed followed by application of timolol daily

Topical timolol with fractional CO2 laser treatment of infantile hemangioma

Eligibility Criteria

Age1 Month - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • , aged 1 month to 12 years
  • \- presenting with superficial, deep, mixed, or proliferating IH.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, 11562, Egypt

Location

MeSH Terms

Conditions

Hemangioma, Capillary

Interventions

propranolol mustard

Condition Hierarchy (Ancestors)

HemangiomaNeoplasms, Vascular TissueNeoplasms by Histologic TypeNeoplasms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer, Dermatology Department

Study Record Dates

First Submitted

April 24, 2026

First Posted

May 1, 2026

Study Start

January 1, 2025

Primary Completion

January 1, 2026

Study Completion

January 1, 2026

Last Updated

May 1, 2026

Record last verified: 2026-04

Locations

EG(1)