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Evaluation of the efficacy and safety of local corticosteroid injections for small, limited involuting infantile hemangiomas at risk of cosmetic disfigurement: a randomized, single-center controlled trial

Evaluation of the efficacy and safety of local corticosteroid injections for small, limited involuting infantile hemangiomas at risk of cosmetic disfigurement: a randomized, single-center controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300077619
Enrollment
Unknown
Registered
2023-11-14
Start date
2023-11-15
Completion date
Unknown
Last updated
2023-11-21

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

Conditions

infantile hemangioma

Interventions

Local injection group of involuting hemangiomas:Monthly intralesional Disprospan injections of up to 1 ml for a total of up to 3 courses
Observation group of involuting hemangiomas:No specific treatment for hemangiomas with regular follow-up to observe spontaneous regression

Sponsors

Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 2 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 1 to 2 years old (including 1 year old and 2 years old), regardless of gender; 2. Patients with a clear diagnosis of infantile hemangioma with medical history, clinical presentation and imaging (ultrasound or CT or MRI); 3. Patients with the maximum diameter of a single hemangioma less than 2 cm; 4. Patients whose appearance is significantly affected by the hemangioma and is at risk of disfigurement; 5. Patients whose guardians understand the study content and treatment risks, sign an informed consent form and are willing to cooperate with the study.

Exclusion criteria

Exclusion criteria: 1. Patients who have a history of severe allergy; 2. Patients who have been previously given systemic, intra-focal or topical corticosteroids, vincristine, alpha-interferon, imiquimod, or other beta-blockers; 3. Patients whose mother has been breastfeeding them during treatment with beta-blockers, systemic (oral, intravenous or intramuscular) corticosteroids, vincristine or alpha-interferon; 4. Patients born more than 2 months prematurely or less than 60 days old; 5. Patients who have received any treatment for hemangioma (including surgery, hormonal drugs and laser treatment); 6. Patients with ulcers on the surface of the tumor; 7. Patients with other skin diseases such as eczema or milk moss on the surface of the tumor or surrounding skin; 8. Patients who have received any other study drug within 4 weeks prior to screening; 9. Patients who, in the opinion of the investigator, are not suitable for participation in this study.

Design outcomes

Primary

MeasureTime frame
Hemangioma volume;

Countries

China

Contacts

Public ContactXiaoxi Lin

Shanghai Ninth People's Hospital, Shanghai Jiao Tong 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