Port Wine Stains
Conditions
Keywords
laser, pediatric, skin pigmentation
Brief summary
The primary objective is to determine the effects of Aldara on the cosmetic outcome of laser treatment of vascular malformations.
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.
Interventions
DRUGImiquimod
commercially available topical antiviral drug
DRUGnon-medicated petroleum cream
Over the counter topical cream used to aid the healing process in skin lesions
Sponsors
Graceway Pharmaceuticals, LLC
Henry Vasconez
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 60 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effects of Aldera Cream on the Reduction of Port Wine Stain (Vascular Malformation) | 3 months | Lesions will be digitally photographed and its surface area measured by blinded observers using image analysis software |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Imiquimod (Aldara): .5 oz cream nightly to the affected area | 4 |
| 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.
non-medicated petroleum cream: .5 oz cream nightly to the affected area | 3 |
| Total | 7 |
Baseline characteristics
| Characteristic | Aldara Cream | Non-medicated Petroleum Cream | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 4 Participants | 3 Participants | 7 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 4 participants | 3 participants | 7 participants |
| Sex: Female, Male Female | 3 Participants | 2 Participants | 5 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 3 |
| other Total, other adverse events | 0 / 4 | 0 / 3 |
| serious Total, serious adverse events | 0 / 4 | 0 / 3 |
Outcome results
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
Time frame: 3 months