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Study for Dexamethasone - Propranolol sustained-release film in the Treatment of Infantile Hemangioma

Study for Dexamethasone - Propranolol sustained-release film in the Treatment of Infantile Hemangioma

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900020553
Enrollment
Unknown
Registered
2019-01-08
Start date
2019-03-01
Completion date
Unknown
Last updated
2019-01-14

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

Conditions

Infantile Hemangioma

Interventions

experiment group:Local application of Dex-Pro SRF
Control group:Intratumoral injection of triamcinolone acetonide

Sponsors

Tianjin Medical University Eye Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age from birth to 1 year old (Infant hemangioma of the eye occurs at most within 3 months after birth, and then grows faster in the next 3 months. After 1 year old, the lesion tends to be stationary, and some have spontaneous tendency to regress); 2. Gender: male or female; 3. Course of disease less than 1 year; 4. Indications: Patients diagnosed with infantile hemangioma (IH); (1) Surface IH involving the dermis of the skin (eyelids and face or body); (2) Hybrid IH that simultaneously invades the skin and subcutaneous tissue or deep eyelids; 5. Meet any of the following clinical manifestations: (1) Rapid tumor growth; (2) Significant deformities of eyelids or orbits caused by the location of tumors affect the appearance; (3) The tumor blocks the eye and has the risk of forming amblyopia; (4) Tumor compression eyeball displacement and protrusion; 6. The subject's guardian has a strong need for treatment, fully understands the condition, and signs an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Hemangioma of large area, covering special parts of the body or skin, should be given special care, under the strict surveillance of pediatricians, medication treatment; 2. During the period of acute upper respiratory tract infection, acute bronchitis, bronchiolitis and bronchopneumonia; 3. Infants with congenital maldevelopment of other organs; 4. abnormal heart, liver and kidney functions; 5. those who have allergic history to many drugs; 6. Any medical history, according to the investigator's judgment, may interfere with the test results or increase the risk of patients; 7. Those who have been treated with glucocorticoid in half a year; 8. Those who had been treated with beta blockers within half a year; 9. Participants in other drug clinical trials in the last three months; 10. Those who cannot follow up on schedule or cooperate with researchers.

Design outcomes

Primary

MeasureTime frame
Tumor size;

Countries

China

Contacts

Public ContactLin Tingting

Tianjin Medical University Eye Hospital

ltt6123@126.com+86 15522858336

Outcome results

None listed

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