The Effects of Aldara as an Adjunct to Laser Treatment (NCT00979550) | Clinical Trial Compass
TerminatedPhase 2
The Effects of Aldara as an Adjunct to Laser Treatment
Stopped: Failure to enroll enough participants
United States7 participantsStarted 2008-10
Plain-language summary
The primary objective is to determine the effects of Aldara on the cosmetic outcome of laser treatment of vascular malformations.
Who can participate
Age range2 Years – 60 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Effects of Aldera Cream on the Reduction of Port Wine Stain (Vascular Malformation)