The Effects of Aldara as an Adjunct to Laser Treatment

This study has been completed.
Sponsor:
Collaborator:
Graceway Pharmaceuticals, LLC
Information provided by (Responsible Party):
Betsy Fink, University of Kentucky
ClinicalTrials.gov Identifier:
NCT00979550
First received: September 17, 2009
Last updated: August 12, 2013
Last verified: August 2013
  Purpose

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


Condition Intervention Phase
Port Wine Stains
Drug: Imiquimod (Aldara)
Drug: non-medicated petroleum cream
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Aldara as an Adjunct to Laser Treatment of Port Wine Stains

Resource links provided by NLM:


Further study details as provided by University of Kentucky:

Primary Outcome Measures:
  • The primary objective is to determine the effects of Aldara on the cosmetic outcome of laser treatment of vascular malformations. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: October 2008
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aldara cream
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.
Drug: Imiquimod (Aldara)
.5 oz cream nightly to the affected area
Placebo Comparator: non-medicated petroleum cream
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.
Drug: non-medicated petroleum cream
.5 oz cream nightly to the affected area

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.

  Eligibility

Ages Eligible for Study:   2 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00979550

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

No publications provided

Responsible Party: Betsy Fink, Regulatory aide, University of Kentucky
ClinicalTrials.gov Identifier: NCT00979550     History of Changes
Other Study ID Numbers: UK Aldara
Study First Received: September 17, 2009
Last Updated: August 12, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kentucky:
laser
pediatric
skin pigmentation

Additional relevant MeSH terms:
Port-Wine Stain
Skin Abnormalities
Congenital Abnormalities
Skin Diseases
Imiquimod
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Interferon Inducers

ClinicalTrials.gov processed this record on August 18, 2014