The Effects of Aldara as an Adjunct to Laser Treatment

Henry Vasconez

Status and phase

Terminated

Phase 2

Conditions

Port Wine Stains

Treatments

Drug: Imiquimod

Drug: non-medicated petroleum cream

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00979550

UK Aldara

Details and patient eligibility

About

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

Full 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.

Enrollment

7 patients

Sex

All

Ages

2 to 60 years old

Volunteers

No Healthy Volunteers

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.