The Effects of Aldara as an Adjunct to Laser Treatment

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2013-08-31

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.

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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.

Conditions

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Port Wine Stains

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Aldara cream

Imiquimod (Aldara cream) will be applied nightly for four weeks after standard of care laser treatment for port wine stain.

Group Type EXPERIMENTAL

Imiquimod

Intervention Type DRUG

commercially available topical antiviral drug

non-medicated petroleum cream

Non-medicated petroleum cream will be applied nightly for four weeks after standard of care laser treatment for port wine stain.

Group Type PLACEBO_COMPARATOR

non-medicated petroleum cream

Intervention Type DRUG

Over the counter topical cream used to aid the healing process in skin lesions

Interventions

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Imiquimod

commercially available topical antiviral drug

Intervention Type DRUG

non-medicated petroleum cream

Over the counter topical cream used to aid the healing process in skin lesions

Intervention Type DRUG

Other Intervention Names

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Aldara

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.

Minimum Eligible Age

2 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No