Infantile Hemangioma (IH)NCT07104526
Low-Dose Propranolol and Bleomycin for Infantile Hemangioma (IH)
A study testing Propranolol + Bleomycin and Propranolol in people with Infantile Hemangioma (IH), run by Wuhan Integrated Traditional Chinese and Western Medicine Hospital at 1 site in China.
Trial summary
This is a prospective, randomized controlled trial designed to evaluate the efficacy and safety of low-dose oral propranolol (1 mg/kg/day) combined with monthly intralesional bleomycin injections versus low-dose propranolol monotherapy for the treatment of infantile hemangioma (IH). Read more about this study
- Who is it for?
- Ages Up to 12 months
- Conditions the study is for
- Infantile Hemangioma (IH)
- What is being tested?
- Propranolol + Bleomycin and Propranolol
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 1 Jan 2025
- 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 Up to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age ≤12 months.
- Clinically and/or imaging-diagnosed infantile hemangioma requiring treatment.
- No prior treatment for IH.
- Guardians willing to comply with the study protocol and provide informed consent.
Who cannot join
- Known hypersensitivity to propranolol or bleomycin.
- Congenital or mixed hemangiomas distinct from IH.
- Significant cardiopulmonary, hepatic, or renal dysfunction.
- Presence of other severe systemic diseases.
- PHACE syndrome or major congenital anomalies that could interfere with treatment or assessment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Efficacy and Safety of Low-Dose Propranolol Combined With Intralesional Bleomycin for Infantile Hemangioma: A Randomized Controlled Trial
This is a prospective, randomized controlled trial designed to evaluate the efficacy and safety of low-dose oral propranolol (1 mg/kg/day) combined with monthly intralesional bleomycin injections versus low-dose propranolol monotherapy for the treatment of infantile hemangioma (IH). A total of 260 infants were randomized to either the combination group or the control group. The study aims to determine if the combination therapy offers superior clinical outcomes, including faster regression, better color resolution, and reduced scarring over a 6-month treatment period.
Read the detailed description
Infantile hemangioma (IH) is the most common benign vascular tumor in infancy. While oral propranolol is the first-line systemic therapy, its efficacy can be limited or slow for certain IHs. Intralesional bleomycin offers a targeted local therapy. This study investigates whether combining low-dose propranolol with local bleomycin injections can enhance therapeutic effects while maintaining a good safety profile. This prospective, randomized, controlled, open-label trial with blinded outcome assessment enrolled 260 infants with IH. Participants were randomly assigned to receive either oral propranolol (1 mg/kg/day) plus monthly intralesional bleomycin (Combination Group) or oral propranolol (1 mg/kg/day) alone (Control Group) for 6 months. The primary objective is to compare the clinical therapeutic effect between the two groups at 6 months. Secondary objectives include evaluating early tumor response, changes in tumor volume and color, long-term scar formation, and the incidence of adverse events. The findings aim to provide robust evidence for a potentially more effective combination treatment strategy for IH.
- Conditions
- Infantile Hemangioma (IH)
- Being tested
- Propranolol + Bleomycin, Propranolol
- 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 + BleomycinDrug
Oral propranolol at 1 mg/kg/day for 6 months plus intralesional bleomycin (1 mg/mL solution) injected once monthly. The bleomycin dose was 0.2-0.5 mg per injection site, not exceeding a total of 1 mg/kg per session or a cumulative dose of 10 mg.
PropranololDrug
Oral propranolol hydrochloride solution administered at a dose of 1 mg/kg/day for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Combination Therapy Group | Experimental | Participants received oral propranolol hydrochloride solution at a dose of 1 mg/kg/day (in two divided doses) for 6 months, combined with intralesional injections of bleomycin. Bleomycin injections were administered once a month for up to 6 months. Receives: Drug: Propranolol + Bleomycin |
| Active Comparator: Propranolol Monotherapy Group | Active comparator | Participants received oral propranolol hydrochloride solution at a dose of 1 mg/kg/day (in two divided doses). The total treatment duration was 6 months. Receives: Drug: Propranolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Therapeutic Effect
Categorized as Complete Regression (>95% volume reduction), Marked Effectiveness (≥75% to 95% volume reduction), Effective (30% to <75% reduction), or Ineffective (<30% reduction). The primary measure is the rate of participants achieving Complete Regression or Marked Effectiveness.
Measured: 6 Months
Secondary outcomes (5)
Early Tumor Surface Atrophy
Assessed by comparing photographs and graded as Obvious Atrophy, Mild Atrophy, or No Obvious Change.
Measured: 24 hours after the first treatment
Change in Hemangioma Color Score
Rated on a 4-point subjective scale (0-3) based on standardized digital photographs, where a lower score indicates color closer to normal skin. The change from baseline is assessed.
Measured: Baseline, 6 Months
Change in Tumor Volume
Measured in cubic centimeters (cm³) using high-frequency color Doppler ultrasound (Volume = length × width × height × 0.52). The change from baseline is assessed.
Measured: Baseline, 6 Months
Vancouver Scar Scale (VSS) Score
Assessed at the former hemangioma site. The VSS evaluates pigmentation, vascularity, pliability, and height, with a total score from 0 (normal skin) to 13 (worst scar). Lower scores indicate better outcomes.
Measured: 6 Months
Incidence of Adverse Events
Number and type of local and systemic adverse events reported by guardians or observed clinically (e.g., injection site reactions, bradycardia, hypoglycemia, sleep disturbances).
Measured: Through study completion (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start1 Jan 2024
- Primary completion1 Jan 2025
- Study completion1 Jan 2025
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.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wuhan Integrated Traditional Chinese and Western Medicine Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bin Zhou, Wuhan Integrated Traditional Chinese and Western Medicine Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07104526
- Sponsor's protocol ID
- 2023R064-E01
- Status last verified
- Jul 2025
- First submitted
- 29 Jul 2025
- Last updated
- 5 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of Low-Dose Propranolol Combined With Intralesional Bleomycin for Infantile Hemangioma: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07104526
- Acronym / sponsor ID
- 2023R064-E01
- Conditions
- Infantile Hemangioma (IH)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Wuhan Integrated Traditional Chinese and Western Medicine HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 5 Aug 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.
This is a prospective, randomized controlled trial designed to evaluate the efficacy and safety of low-dose oral propranolol (1 mg/kg/day) combined with monthly intralesional bleomycin injections versus low-dose propranolol monotherapy for the treatment of infantile hemangioma (IH). A total of 260 infants were randomized to either the combination group or the control group. The study aims to determine if the combination therapy offers superior clinical outcomes, including faster regression, better color resolution, and reduced scarring over a 6-month treatment period.
Detailed description
Infantile hemangioma (IH) is the most common benign vascular tumor in infancy. While oral propranolol is the first-line systemic therapy, its efficacy can be limited or slow for certain IHs. Intralesional bleomycin offers a targeted local therapy. This study investigates whether combining low-dose propranolol with local bleomycin injections can enhance therapeutic effects while maintaining a good safety profile. This prospective, randomized, controlled, open-label trial with blinded outcome assessment enrolled 260 infants with IH. Participants were randomly assigned to receive either oral propranolol (1 mg/kg/day) plus monthly intralesional bleomycin (Combination Group) or oral propranolol (1 mg/kg/day) alone (Control Group) for 6 months. The primary objective is to compare the clinical therapeutic effect between the two groups at 6 months. Secondary objectives include evaluating early tumor response, changes in tumor volume and color, long-term scar formation, and the incidence of adverse events. The findings aim to provide robust evidence for a potentially more effective combination treatment strategy for IH.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Combination Therapy Group | Experimental | Drug: Propranolol + BleomycinParticipants received oral propranolol hydrochloride solution at a dose of 1 mg/kg/day (in two divided doses) for 6 months, combined with intralesional injections of bleomycin. Bleomycin injections were administered once a month for up to 6 months. |
| Active Comparator: Propranolol Monotherapy Group | Active comparator | Drug: PropranololParticipants received oral propranolol hydrochloride solution at a dose of 1 mg/kg/day (in two divided doses). The total treatment duration was 6 months. |
Who may qualify
- Ages
- Up to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age ≤12 months.
- Clinically and/or imaging-diagnosed infantile hemangioma requiring treatment.
- No prior treatment for IH.
- Guardians willing to comply with the study protocol and provide informed consent.
Key exclusion criteria (5 listed)
- Known hypersensitivity to propranolol or bleomycin.
- Congenital or mixed hemangiomas distinct from IH.
- Significant cardiopulmonary, hepatic, or renal dysfunction.
- Presence of other severe systemic diseases.
- PHACE syndrome or major congenital anomalies that could interfere with treatment or assessment.
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 + BleomycinOral propranolol at 1 mg/kg/day for 6 months plus intralesional bleomycin (1 mg/mL solution) injected once monthly. The bleomycin dose was 0.2-0.5 mg per injection site, not exceeding a total of 1 mg/kg per session or a cumulative dose of 10 mg. | Drug | Experimental: Combination Therapy Group |
| PropranololOral propranolol hydrochloride solution administered at a dose of 1 mg/kg/day for 6 months. | Drug | Active Comparator: Propranolol Monotherapy Group |
Primary outcome
Clinical Therapeutic Effect
Time frame: 6 Months
Categorized as Complete Regression (>95% volume reduction), Marked Effectiveness (≥75% to 95% volume reduction), Effective (30% to <75% reduction), or Ineffective (<30% reduction). The primary measure is the rate of participants achieving Complete Regression or Marked Effectiveness.
5 secondary outcomes
Early Tumor Surface Atrophy
Time frame: 24 hours after the first treatment
Change in Hemangioma Color Score
Time frame: Baseline, 6 Months
Change in Tumor Volume
Time frame: Baseline, 6 Months
Vancouver Scar Scale (VSS) Score
Time frame: 6 Months
Incidence of Adverse Events
Time frame: Through study completion (6 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 5 Aug 2025.
Related trials for Infantile Hemangioma (IH)
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Not yet recruitingPhase 4
Abrupt Discontinuation Versus Gradual Tapering of Propranolol in Infantile Hemangioma
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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. 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 + Bleomycin and Propranolol in people with Infantile Hemangioma (IH), run by Wuhan Integrated Traditional Chinese and Western Medicine Hospital at 1 site 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 4 inclusion and 5 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 5 Aug 2025. 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 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.
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?
Clinical Therapeutic Effect (time frame: 6 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 5 Aug 2025.