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Efficacy and safety of oral propranolol versus topical timolol maleate in the treatment of large superficial infantile hemangiomas: a randomized controlled trial

Efficacy and safety of oral propranolol versus topical timolol maleate in the treatment of large superficial infantile hemangiomas: a randomized controlled trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300073378
Enrollment
Unknown
Registered
2023-07-10
Start date
2022-02-09
Completion date
Unknown
Last updated
2023-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infantile hemangioma

Interventions

Topical group:topical timolol maleate treatment
Oral group:oral propranolol treatment

Sponsors

Shanghai Ninth People's Hospital, Shanghai Jiaotong University School Of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 9 Months

Inclusion criteria

Inclusion criteria: 1. Children with hemangioma in infants younger than 9 months who meet the diagnostic criteria of ISSVA. 2. Proliferative superficial infantile hemangioma at a single anatomical site. 3. The lesion area of infantile hemangioma is greater than 20 cm2. 4. No oral or topical beta-blocker drugs, laser, local drug injection, etc. have been used before the initial diagnosis. 5. Willing to accept and cooperate with treatment, and regular follow-up.

Exclusion criteria

Exclusion criteria: 1. The child has severe immune deficiency or congenital disease. 2. Complications such as ulceration and infection have occurred. 3. Hypersensitivity to beta-blockers or corresponding contraindications, including bronchial asthma; cardiogenic shock; heart block (?-? degree atrioventricular block); severe or acute heart failure; too slow. 4. Superficial hemangiomas in special parts that are not suitable for treatment with topical creams, such as perineum, lips, and eyes. 5. Participating in other clinical trials or taking other drugs that are contraindicated in combination with beta-blockers.

Design outcomes

Primary

MeasureTime frame
Visual analogue scale;Area of infantile hemangioma;Color of infantile hemangioma;

Secondary

MeasureTime frame
Visual analogue scale;Area of infantile hemangioma;

Countries

China

Contacts

Public ContactLin Xiaoxi

Shanghai Ninth People's Hospital, Shanghai Jiaotong University School Of Medicine

linxiaoxi@126.com+86 137 0199 7136

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026