Infantile Hemangioma (IH)NCT07560332
Oral Propranolol Versus Fractional Carbon Dioxide CO2 Laser Assisted Delivery of Topical Timolol for Treatment of Infantile Hemangioma
A study testing Propranolol 1 and Fractional CO2 laser with topical timolol in people with Infantile Hemangioma (IH), run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 12 years
- Conditions the study is for
- Infantile Hemangioma (IH)
- What is being tested?
- Propranolol 1 and Fractional CO2 laser with topical timolol
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2025to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- , aged 1 month to 12 years
- presenting with superficial, deep, mixed, or proliferating IH.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Infantile Hemangioma (IH)
- Being tested
- Propranolol 1, Fractional CO2 laser with topical timolol
- Keywords
- propranolol, timolol, carbon dioxide laser, infantile hemangioma
- Medical subject headings
- Hemangioma, Capillary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propranolol 1Drug
oral propranolol is given daily in a dose of 1 to 2 mgékg daily for 3 months
Fractional CO2 laser with topical timololDevice
Weekly sessions were performed followed by application of timolol daily
| Study group | Role | What they receive |
|---|---|---|
| Propranolol | Active comparator | oral propranolol group for treatment of infantile hemangioma Receives: Drug: Propranolol 1 |
| Topical timolol with fractional CO2 laser treatment of infantile hemangioma | Experimental | weekly session of fractional CO2 laser with topical timolol application Receives: Device: Fractional CO2 laser with topical timolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of global assessment score of infantile hemangioma
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start1 Jan 2025
- Primary completion1 Jan 2026
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infantile Hemangioma (IH)Studies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Elbendary, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07560332
- Sponsor's protocol ID
- MS-443-2022
- Status last verified
- Apr 2026
- First submitted
- 24 Apr 2026
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Propranolol Versus Fractional Carbon Dioxide CO2 Laser Assisted Delivery of Topical Timolol for Treatment of Infantile Hemangioma; A Randomized Controlled Comparative Study
- ClinicalTrials.gov ID
- NCT07560332
- Acronym / sponsor ID
- MS-443-2022
- Conditions
- Infantile Hemangioma (IH)
- Keywords
- propranolol, timolol, carbon dioxide laser, infantile hemangioma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 1 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propranolol | Active comparator | Drug: Propranolol 1oral propranolol group for treatment of infantile hemangioma |
| Topical timolol with fractional CO2 laser treatment of infantile hemangioma | Experimental | Device: Fractional CO2 laser with topical timololweekly session of fractional CO2 laser with topical timolol application |
Who may qualify
- Ages
- 1 month to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- , aged 1 month to 12 years
- presenting with superficial, deep, mixed, or proliferating IH.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Propranolol 1oral propranolol is given daily in a dose of 1 to 2 mgékg daily for 3 months | Drug | Propranolol |
| Fractional CO2 laser with topical timololWeekly sessions were performed followed by application of timolol daily | Device | Topical timolol with fractional CO2 laser treatment of infantile hemangioma |
Primary outcome
Improvement of global assessment score of infantile hemangioma
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Infantile Hemangioma (IH)
Not yet recruitingObservational study
Risk Stratification and Treatment Decisions in Infantile Hemangioma With Minimal or Arrested Growth
Infantile Hemangioma (IH)
Not yet recruitingPhase 4
Abrupt Discontinuation Versus Gradual Tapering of Propranolol in Infantile Hemangioma
Infantile Hemangioma (IH)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propranolol 1 and Fractional CO2 laser with topical timolol in people with Infantile Hemangioma (IH), run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of global assessment score of infantile hemangioma (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.