Infantile HemangiomaPhase 2/3NCT06798363
Efficacy and Safety of Different Initial Doses of Oral Propranolol in the Treatment of Ulcerated Infantile Hemangioma
A Phase 2/3 study testing propranolol in people with Infantile Hemangioma, run by West China Hospital at 3 sites in China.
Trial summary
The main objective of this study was to determine the efficacy of different doses of propranolol in the treatment of ulcerattion infantile hemangioma (IH). Read more about this study
- Who is it for?
- Ages Up to 1 year
- Conditions the study is for
- Infantile Hemangioma
- What is being tested?
- propranolol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 3 sitesChina
- Study dates
- 1 Jan 2025to 30 Mar 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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 Up to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- all patients with ulcer IH;
- children with ulcer IH treated with propranolol.
Who cannot join
- 1) children with ulcer IH who received other therapeutic interventions were excluded; 2) Children whose families refused to participate in the study; 3) patients with contraindications to oral propranolol, such as allergy to propranolol, severe bradycardia and bronchial asthma; 4) children lost to follow-up during oral propranolol treatment; 5) children unable to oral propranolol or continue to oral propranolol due to other reasons.
- -
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
Yi Ji, +862885423453, jijiyuanyuan@163.com
jijiyuanyuan@163.com
- Recruiting
Sichuan Women and Children's Hospital
Chengdu, Sichuan, 610045
Wei Shan MD, MD, 0288637344, wojiaosw@163.com
Wei Shan, MD, 0288637344, wojiaosw@163.com
- Recruiting
West China Second University Hospital of Sichuan University
Chengdu, Sichuan, 610066
Fan Hu MD, PhD, 0288687534, 1192207528@qq.com
Fan Hu, PhD, 1192207528@qq.com
About this study
Official title: Efficacy and Safety of Different Initial Doses of Oral Propranolol in the Treatment of Ulcerated Infantile Hemangioma： a Prospective Study
The main objective of this study was to determine the efficacy of different doses of propranolol in the treatment of ulcerattion infantile hemangioma (IH).
Read the detailed description
Infantile hemangioma (IH) is the most common benign tumor in infants, with an estimated prevalence of 4%-5%. Although most IH resolves over time without serious sequelae, a significant proportion can lead to serious complications such as ulcers. Propranolol is considered to be an effective treatment modality for ulceration IH, and there are retrospective studies suggesting that starting treatment at a low dose is safe and effective. However, due to the lack of prospective study, the effectiveness of different doses of propranolol for initiating treatment of ulceration IH is unknown. Therefore, a prospective study of ulceration IHs in Chinese children was conducted to clarify its efficacy.
- Conditions
- Infantile Hemangioma
- Being tested
- propranolol
- Keywords
- Infantile hemangioma, ulcer, propranolol
- Medical subject headings
- Hemangioma, Capillary, Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propranololDrug
different dose
| Study group | Role | What they receive |
|---|---|---|
| low dose | Experimental | 1mg/kg/d Receives: Drug: propranolol |
| high dose | Active comparator | 2mg/kg/d Receives: Drug: propranolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to ulcer healing
Time from the start of treatment with propranolol to complete ulcer healing
Measured: 0.5 years
Secondary outcomes (2)
The resolution of IH at month 6 after treatment
complete resolution/complete resolution/partial resolution/no effect/withdrawal from treatment
Measured: 0.5 years
adverse events
The incidence of adverse events in the two groups after oral propranolol at different doses
Measured: 0.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start1 Jan 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infantile HemangiomaStudies of the same condition, open and under way.
- More trials run by West China HospitalThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi Ji, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06798363
- Sponsor's protocol ID
- RCT20250123
- Status last verified
- Sep 2026
- First submitted
- 23 Jan 2025
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Different Initial Doses of Oral Propranolol in the Treatment of Ulcerated Infantile Hemangioma： a Prospective Study
- ClinicalTrials.gov ID
- NCT06798363
- Acronym / sponsor ID
- RCT20250123
- Conditions
- Infantile Hemangioma
- Keywords
- Infantile hemangioma, ulcer, propranolol
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 29 Jan 2025 (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.
The main objective of this study was to determine the efficacy of different doses of propranolol in the treatment of ulcerattion infantile hemangioma (IH).
Detailed description
Infantile hemangioma (IH) is the most common benign tumor in infants, with an estimated prevalence of 4%-5%. Although most IH resolves over time without serious sequelae, a significant proportion can lead to serious complications such as ulcers. Propranolol is considered to be an effective treatment modality for ulceration IH, and there are retrospective studies suggesting that starting treatment at a low dose is safe and effective. However, due to the lack of prospective study, the effectiveness of different doses of propranolol for initiating treatment of ulceration IH is unknown. Therefore, a prospective study of ulceration IHs in Chinese children was conducted to clarify its efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low dose | Experimental | Drug: propranolol1mg/kg/d |
| high dose | Active comparator | Drug: propranolol2mg/kg/d |
Who may qualify
- Ages
- Up to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- all patients with ulcer IH;
- children with ulcer IH treated with propranolol.
Key exclusion criteria (2 listed)
- 1) children with ulcer IH who received other therapeutic interventions were excluded; 2) Children whose families refused to participate in the study; 3) patients with contraindications to oral propranolol, such as allergy to propranolol, severe bradycardia and bronchial asthma; 4) children lost to follow-up during oral propranolol treatment; 5) children unable to oral propranolol or continue to oral propranolol due to other reasons.
- -
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 |
|---|---|---|
| propranololdifferent dose | Drug | high dose, low dose |
Primary outcome
Time to ulcer healing
Time frame: 0.5 years
Time from the start of treatment with propranolol to complete ulcer healing
2 secondary outcomes
The resolution of IH at month 6 after treatment
Time frame: 0.5 years
adverse events
Time frame: 0.5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: No
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing propranolol in people with Infantile Hemangioma, run by West China Hospital at 3 sites in China.
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 2 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: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yi Ji (+862885423453, jijiyuanyuan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to ulcer healing (time frame: 0.5 years). 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 21 Sep 2026.