The Effects of Aldara as an Adjunct to Laser Treatment

• Status: Terminated
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective is to determine the effects of Aldara on the cosmetic outcome of laser treatment of vascular malformations.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Henry Vasconez; University of Kentucky
• Collaborator: Graceway Pharmaceuticals, LLC
• Treatments: Imiquimod

Criteria

Inclusion Criteria:

• Male or female patient between the ages of 2 and 60 years with a vascular malformation that is seeking cosmetic treatment.

• All races will be included as well as male and female.

• Clinical data on the usage of Aldara below the age of 2 years is limited and therefore all patients in the study will have to be at least 2 years of age.

• The majority of port wine stains are initially treated during childhood

• In order to determine the effectiveness of Aldara as an adjunct to laser therapy of Port Wine Stains, some of the patients in the study need to have lesions that have not undergone previous treatment.

Exclusion Criteria:

• Patients under the age of 2 or over the age of 60.

• Patients that have serious medical problems that would put them at risk of the anesthesia.

• Patients that have sensitivity reactions to the ingredients in the product including imiquimod, isostearic acid, cetyl alcohol, stearyl alcohol, white petrolatum, polysorbate 60, sorbitan monostearate, glycerin, xanthan gum, purified water, benzyl alcohol, methylparaben, and propylparaben.

• Patients who are pregnant or have significant immunodeficiency or autoimmune diseases.