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A Phase II Study of Imiquimod 5 % Cream for the Treatment of Hemangioma in Infancy

Phase 2
2 Months
12 Months
Not Enrolling
Hemangioma, Capillary

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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

- 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:


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:


Principal Investigator

Catherine McCuaig, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Justine's Hospital


Canada: Health Canada

Study ID:




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