The Effects of Aldara as an Adjunct to Laser Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00979550
Recruitment Status : Terminated (Failure to enroll enough participants)
First Posted : September 18, 2009
Results First Posted : March 22, 2018
Last Update Posted : March 22, 2018
Graceway Pharmaceuticals, LLC
Information provided by (Responsible Party):
Henry Vasconez, University of Kentucky

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

Condition or disease Intervention/treatment Phase
Port Wine Stains Drug: Imiquimod Drug: non-medicated petroleum cream Phase 2

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  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Aldara as an Adjunct to Laser Treatment of Port Wine Stains
Study Start Date : October 2008
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

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 Name: 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

Primary Outcome Measures :
  1. 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

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Ages Eligible for Study:   2 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00979550

United States, Kentucky
University of Kentucky Division of Plastic Surgery
Lexington, Kentucky, United States, 40536-0284
Sponsors and Collaborators
Henry Vasconez
Graceway Pharmaceuticals, LLC
Principal Investigator: Henry C. Vasconez, MD University of Kentucky

Responsible Party: Henry Vasconez, principal Investigator, University of Kentucky Identifier: NCT00979550     History of Changes
Other Study ID Numbers: UK Aldara
First Posted: September 18, 2009    Key Record Dates
Results First Posted: March 22, 2018
Last Update Posted: March 22, 2018
Last Verified: March 2018

Keywords provided by Henry Vasconez, University of Kentucky:
skin pigmentation

Additional relevant MeSH terms:
Port-Wine Stain
Hemangioma, Capillary
Vascular Malformations
Skin Abnormalities
Congenital Abnormalities
Skin Diseases
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Cardiovascular Abnormalities
Cardiovascular Diseases
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Interferon Inducers