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Tracking Information | |||||
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First Received Date † | January 14, 2008 | ||||
Last Updated Date | January 24, 2008 | ||||
Start Date † | March 2005 | ||||
Current Primary Outcome Measures † |
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 ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00601016 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | A Phase II Study of Imiquimod 5 % Cream for the Treatment of Hemangioma in Infancy | ||||
Official Title † | A Phase II Study of Imiquimod 5 % Cream for the Treatment of Hemangioma in Infancy | ||||
Brief Summary | 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. |
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Detailed Description | |||||
Study Phase | Phase II | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study | ||||
Condition † | Hemangioma, Capillary | ||||
Intervention † | Drug: Imiquimod 5% cream | ||||
Study Arms / Comparison Groups | |||||
Publications * | McCuaig CC, Dubois J, Powell J, Belleville C, David M, Rousseau E, Gendron R, Jafarian F, Auger I. A phase II, open-label study of the efficacy and safety of imiquimod in the treatment of superficial and mixed infantile hemangioma. Pediatr Dermatol. 2009 Mar-Apr;26(2):203-12. | ||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Completed | ||||
Enrollment † | 18 | ||||
Completion Date | September 2006 | ||||
Primary Completion Date | September 2006 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 2 Months to 12 Months | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | Canada | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00601016 | ||||
Responsible Party | Catherine McCuaig, Pricipal Investigator, CHU Siante-Justine, CHU Sainte-Justine | ||||
Secondary IDs †† | 1 | ||||
Study Sponsor † | St. Justine's Hospital | ||||
Collaborators †† | Graceway Pharmaceuticals, LLC | ||||
Investigators † |
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Information Provided By | St. Justine's Hospital | ||||
Verification Date | January 2008 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |