A Phase II Study of Imiquimod 5 % Cream for the Treatment of Hemangioma in Infancy
Phase 2
2 Months
12 Months
2 Months
12 Months
Not Enrolling
Both
Hemangioma, Capillary
Both
Hemangioma, Capillary
Trial Information
A Phase II Study of Imiquimod 5 % Cream for the Treatment of Hemangioma in Infancy
Inclusion Criteria:
- Healthy infants aged 2-12 months.
- Superficial or mixed hemangiomas in proliferative phase (growing in size in the last
1-2 months).
- Hemangiomas must be less than 10X10 cm and must not be ulcerated.
Exclusion Criteria:
- Preterm infant (less than 36 weeks of gestation).
- Ulceration of hemangioma prior to treatment.
- Immunosuppression.
- Hemangioma located on the eyelid or perianal region.
- Prior treatment of the hemangioma.
- Concomitant diseases.
- Presence of multiple hemangiomas and/or hemangiomas that would require systemic drug
treatment.
- Potential difficulties with follow-up (patient from another town,difficult access to
the hospital , etc.).
- History of allergy to any of the components of the drug preparation.
- Hemangiomas more than 10X 10 cm or ulcerated before the start of the treatment.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To document the efficacy of Imiquimod 5% cream in the treatment of hemangioma of infancy.
Outcome Time Frame:
Cream is applied for 4 months. Visits occured at month 1, 2, 4, and 8.
Safety Issue:
No
Principal Investigator
Catherine McCuaig, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
St. Justine's Hospital
Authority:
Canada: Health Canada
Study ID:
1-Mccuaig
NCT ID:
NCT00601016
Start Date:
March 2005
Completion Date:
September 2006
Related Keywords:
- Hemangioma, Capillary
- Infantile hemangioma
- Hemangioma
- Hemangioma of Infancy
- benign tumors of infancy
- Congenital hemangioma
- Capillary
- Hemangioma
- Hemangioma, Capillary
Name | Location |
|---|
