A Phase II Study of Imiquimod 5 % Cream for the Treatment of Hemangioma in Infancy
Hemangiomas of infancy, the most common benign tumors of infancy, are congenital or early infancy lesions characterized by a rapid postnatal growth, with high expression of angiogenic stimulators for 9-18 months, followed by slow regression for 5-9 years. Current therapies for the hemangiomas are usually restricted to more severe forms due to the risks of adverse effects, inconvenience and cost. Nevertheless, a substantial amount of the psychological discomfort and morbidity can be caused by untreated hemangiomas, especially those in the face.
Recently, Imiquimod 5% cream has emerged as a safe an effective drug for several skin conditions that benefit from modulation of the activity of the immune system, such as common warts and various forms of the skin pre-cancerous and cancerous lesions. Small case reports series have suggest that it could also be useful in hemangiomas, possibly through the inhibition of the angiogenesis by local IFN production.This is a small, open label study of 16 patients to document the efficacy of the Imiquimod 5% cream in the treatment of hemangioma of infancy (primary outcome). IFN and plasma drug levels, as well as clinical examinations and blood studies, will be carried out to evaluate safety of the treatment (secondary outcome). bFGF and VEGF will be measured in blood and urine in order to study the diagnostic and predictive value of these pro-angiogenic factors in the response of hemangiomas to the treatment with Imiquimod (secondary outcome).
The study is a phase II clinical trial of a once a day application of Imiquimod 5% cream, 3 to 7 times per week for a maximum of four months. The study held at the Dermatology Clinic of Sainte-Justine Hospital, and was completed within a 20 months timeframe after IRB approval.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Imiquimod 5 % Cream for the Treatment of Hemangioma in Infancy|
- To document the efficacy of Imiquimod 5% cream in the treatment of hemangioma of infancy. [ Time Frame: Cream is applied for 4 months. Visits occured at month 1, 2, 4, and 8. ] [ Designated as safety issue: No ]
- IFN and plasma drug levels, as well as clinical examinations and blood studies, will be carried out to evaluate safety of the treatment. [ Time Frame: 4 months of treatment. Doage done at each study visits (Month 1, 2 .4 and 8). ] [ Designated as safety issue: Yes ]
- bFGF and VEGF will be measured in blood and urine in order to study the diagnostic and predictive value of these pro-angiogenic factors in the response of hemangiomas to the treatment with Imiquimod. [ Time Frame: 4 months of treament with a follow-up at 8 months. ] [ Designated as safety issue: No ]
|Study Start Date:||March 2005|
|Study Completion Date:||September 2006|
|Primary Completion Date:||September 2006 (Final data collection date for primary outcome measure)|
Drug: Imiquimod 5% cream
- Imiquimod 5% cream = Aldara
- Item ID = GH-6203-0328-5, CUP-051119552409
- DIN number = 02239505
- Lot number -= GFK026A
|Sainte-Justine Hospital University Center (CHU)|
|Montreal, Quebec, Canada, H3T 1C5|
|Principal Investigator:||Catherine McCuaig, M.D.||St. Justine's Hospital|