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

This study has been completed.
Sponsor:
Collaborator:
Graceway Pharmaceuticals, LLC
Information provided by:
St. Justine's Hospital
ClinicalTrials.gov Identifier:
NCT00601016
First received: January 14, 2008
Last updated: January 24, 2008
Last verified: January 2008
  Purpose

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.


Condition Intervention Phase
Hemangioma, Capillary
Drug: Imiquimod 5% cream
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by St. Justine's Hospital:

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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 18
Study Start Date: March 2005
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Imiquimod 5% cream
    Imiquimod 5% cream applied topical on hemangioma once a day , 3 to 7 times a week for a maximum of 4 months.
    Other Names:
    • Imiquimod 5% cream = Aldara
    • Item ID = GH-6203-0328-5, CUP-051119552409
    • DIN number = 02239505
    • Lot number -= GFK026A
  Eligibility

Ages Eligible for Study:   2 Months to 12 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00601016

Locations
Canada, Quebec
Sainte-Justine Hospital University Center (CHU)
Montreal, Quebec, Canada, H3T 1C5
Sponsors and Collaborators
St. Justine's Hospital
Graceway Pharmaceuticals, LLC
Investigators
Principal Investigator: Catherine McCuaig, M.D. St. Justine's Hospital
  More Information

Publications:
Bruckner, A.L. and I.J. Frieden, Hemangiomas of infancy. J Am Acad Dermatol, 2003. 48(4): p. 477-93; quiz 494-6. 2. Dinehart, S.M., J. Kincannon, and R. Geronemus, Hemangiomas: evaluation and treatment. Dermatol Surg, 2001. 27(5): p. 475-85. 3. Jacobs, A.H. and R.G. Walton, The incidence of birthmarks in the neonate. Pediatrics, 1976. 58(2): p. 218-22. 4. Margileth, A.M. and M. Museles, Cutaneous hemangiomas in children. Diagnosis and conservative management. Jama, 1965. 194(5): p. 523-6. 5. Powell, T.G., et al., Epidemiology of strawberry haemangioma in low birthweight infants. Br J Dermatol, 1987. 116(5): p. 635-41. 6. Burton, B.K., et al., An increased incidence of haemangiomas in infants born following chorionic villus sampling (CVS). Prenat Diagn, 1995. 15(3): p. 209-14. 7. Martinez, M.I., et al., Infantile hemangioma: clinical resolution with 5% imiquimod cream. Arch Dermatol, 2002. 138(7): p. 881-4; discussion 884. 8. Gampper, T.J. and R.F. Morgan, Vascular anomalies: hemangiomas. Plast Reconstr Surg, 2002. 110(2): p. 572-85; quiz 586; discussion 587-8. 9. Ceisler, E.J., L. Santos, and F. Blei, Periocular hemangiomas: what every physician should know. Pediatr Dermatol, 2004. 21(1): p. 1-9. 10. Dadras, S.S., et al., Infantile hemangiomas are arrested in an early developmental vascular differentiation state. Mod Pathol, 2004. 17(9): p. 1068-79. 11. Oliver, G. and M. Detmar, The rediscovery of the lymphatic system: old and new insights into the development and biological function of the lymphatic vasculature. Genes Dev, 2002. 16(7): p. 773-83. 12. Vikkula, M., et al., Molecular basis of vascular anomalies. Trends Cardiovasc Med, 1998. 8(7): p. 281-92. 13. Cohen, M.M., Jr., Vasculogenesis, angiogenesis, hemangiomas, and vascular malformations. Am J Med Genet, 2002. 108(4): p. 265-74. 14. Chang, J., et al., Proliferative hemangiomas: analysis of cytokine gene expression and angiogenesis. Plast Reconstr Surg, 1999. 103(1): p. 1-9; discussion 10. 15. Takahashi, K., et al., Cellular markers that distinguish the phases of hemangioma during infancy and childhood. J Clin Invest, 1994. 93(6): p. 2357-64. 16. Bielenberg, D.R., et al., Progressive growth of infantile cutaneous hemangiomas is directly correlated with hyperplasia and angiogenesis of adjacent epidermis and inversely correlated with expression of the endogenous angiogenesis inhibitor, IFN-beta. Int J Oncol, 1999. 14(3): p. 401-8. 17. Ritter, M.R., et al., Insulin-like growth factor 2 and potential regulators of hemangioma growth and involution identified by large-scale expression analysis. Proc Natl Acad Sci U S A, 2002. 99(11): p. 7455-60. 18. Isik, F.F., et al., Monocyte chemoattractant protein-1 mRNA expression in hemangiomas and vascular malformations. J Surg Res, 1996. 61(1): p. 71-6. 19. Dosquet, C., et al., [Importance of bFGF (

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Catherine McCuaig, Pricipal Investigator, CHU Siante-Justine, CHU Sainte-Justine
ClinicalTrials.gov Identifier: NCT00601016     History of Changes
Other Study ID Numbers: 1-Mccuaig, 1
Study First Received: January 14, 2008
Last Updated: January 24, 2008
Health Authority: Canada: Health Canada

Keywords provided by St. Justine's Hospital:
Infantile hemangioma
Hemangioma
Hemangioma of Infancy
benign tumors of infancy
Congenital hemangioma
Capillary

Additional relevant MeSH terms:
Hemangioma
Hemangioma, Capillary
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Vascular Tissue
Imiquimod
Adjuvants, Immunologic
Antineoplastic Agents
Immunologic Factors
Interferon Inducers
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014