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Hemangioma, CapillaryPhase 2NCT00601016

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

A Phase 2 study testing Imiquimod 5% cream in people with Hemangioma, Capillary, run by St. Justine's Hospital at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 2 to 12 months
Conditions the study is for
Hemangioma, Capillary
What is being tested?
Imiquimod 5% cream
How many people
18 participants
Where
1 siteCanada
Study dates
Mar 2005to Sep 2006
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 12 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Sainte-Justine Hospital University Center (CHU)

    Montreal, Quebec, H3T 1C5

Other trials in Canada

About this study

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.

Being tested
Imiquimod 5% cream
Keywords
Infantile hemangioma, Hemangioma, Hemangioma of Infancy, benign tumors of infancy, Congenital hemangioma, Capillary
Medical subject headings
Hemangioma, Capillary, Hemangioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Imiquimod 5% creamDrug

    Also called Imiquimod 5% cream = Aldara, Item ID = GH-6203-0328-5, CUP-051119552409, DIN number = 02239505, Lot number -= GFK026A

    Imiquimod 5% cream applied topical on hemangioma once a day , 3 to 7 times a week for a maximum of 4 months.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To document the efficacy of Imiquimod 5% cream in the treatment of hemangioma of infancy.

    Measured: Cream is applied for 4 months. Visits occured at month 1, 2, 4, and 8.

Secondary outcomes (2)

  1. IFN and plasma drug levels, as well as clinical examinations and blood studies, will be carried out to evaluate safety of the treatment.

    Measured: 4 months of treatment. Doage done at each study visits (Month 1, 2 .4 and 8).

  2. 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.

    Measured: 4 months of treament with a follow-up at 8 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2008 (estimated)
  2. Study startMar 2005
  3. Primary completionSep 2006
  4. Study completionSep 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00601016
Sponsor's protocol ID
1-Mccuaig
Other IDs
1
Status last verified
Jan 2008
First submitted
14 Jan 2008
Last updated
25 Jan 2008
Results posted
No
Data monitoring committee
No

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 (

  • 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. doi: 10.1111/j.1525-1470.2008.00857.x.

    PubMed 19419474

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Imiquimod 5% cream in people with Hemangioma, Capillary, run by St. Justine's Hospital at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00601016, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2008.

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