The Effects of Aldara as an Adjunct to Laser Treatment

Port Wine Stains Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00979550
• Other study ID #: UK Aldara
• Status: Terminated
• Phase: Phase 2
• First received: September 17, 2009
• Last updated: March 19, 2018
• Start date: October 2008
• Est. completion date: August 2013

Study information

• Verified date: March 2018
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hemangioma, Capillary
• Port Wine Stains
• Port-Wine Stain
• Vascular Malformations

Intervention

Drug:
• Imiquimod
commercially available topical antiviral drug
• non-medicated petroleum cream
Over the counter topical cream used to aid the healing process in skin lesions

Locations

Country	Name	City	State
United States	University of Kentucky Division of Plastic Surgery	Lexington	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Henry Vasconez	Graceway Pharmaceuticals, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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