Status:
TERMINATED
The Effects of Aldara as an Adjunct to Laser Treatment
Lead Sponsor:
Henry Vasconez
Collaborating Sponsors:
Graceway Pharmaceuticals, LLC
Conditions:
Port Wine Stains
Eligibility:
All Genders
2-60 years
Phase:
PHASE2
Brief Summary
The primary objective is to determine the effects of Aldara on the cosmetic outcome of laser treatment of vascular malformations.
Detailed Description
This is a randomized, controlled, double-blinded study. Volunteers who are scheduled for laser treatment of Port Wine Stains will be screened and eligible subjects will be asked to participate. The pa...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00979550
Start Date
October 1 2008
End Date
August 1 2013
Last Update
March 22 2018
Active Locations (1)
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1
University of Kentucky Division of Plastic Surgery
Lexington, Kentucky, United States, 40536-0284