The Effects of Aldara as an Adjunct to Laser Treatment

March 19, 2018 updated by: Henry Vasconez

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40536-0284
        • University of Kentucky Division of Plastic Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henry Vasconez

Collaborators

Graceway Pharmaceuticals, LLC

Investigators

  • Principal Investigator: Henry C. Vasconez, MD, University of Kentucky

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

September 17, 2009

First Submitted That Met QC Criteria

September 17, 2009

First Posted (Estimate)

September 18, 2009

Study Record Updates

Last Update Posted (Actual)

March 22, 2018

Last Update Submitted That Met QC Criteria

March 19, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UK Aldara

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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