The Effects of Aldara as an Adjunct to Laser Treatment

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

Detailed Description
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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 patients will be randomized and placed in the experimental or the control group. They will be given unlabeled sachets and instructed to apply the product each night to the right half of their treated lesion beginning the night after surgery for 4 weeks. Digital photographs of the Port Wine Stain will be taken prior to surgery and repeated at follow up appointments at 1 week, 1 month, 2 months, and 3 months after surgery. The photographs will be analyzed by blinded board certified plastic surgeons as well as a computer program.

Official Title
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The Effects of Aldara as an Adjunct to Laser Treatment of Port Wine Stains

Conditions
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Port Wine Stains

Intervention / Treatment
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* Drug: Imiquimod
* Drug: non-medicated petroleum cream


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aldara cream<br>Imiquimod (Aldara cream) will be applied nightly for four weeks after standard of care laser treatment for port wine stain. | Drug: Imiquimod<br>* commercially available topical antiviral drug<br>* Other names: Aldara;|
| Placebo Comparator: non-medicated petroleum cream<br>Non-medicated petroleum cream will be applied nightly for four weeks after standard of care laser treatment for port wine stain. | Drug: non-medicated petroleum cream<br>* Over the counter topical cream used to aid the healing process in skin lesions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of Aldera Cream on the Reduction of Port Wine Stain (Vascular Malformation) | Lesions will be digitally photographed and its surface area measured by blinded observers using image analysis software | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laser, pediatric, skin pigmentation