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The Effects of Aldara as an Adjunct to Laser Treatment

Primary Purpose

Port Wine Stains

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Imiquimod

non-medicated petroleum cream

About this trial

This is an interventional treatment trial for Port Wine Stains focused on measuring laser, pediatric, skin pigmentation

Eligibility Criteria

2 Years - 60 Years (Child, Adult)All SexesDoes not accept 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.

Sites / Locations

University of Kentucky Division of Plastic Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Aldara cream

non-medicated petroleum cream

Arm Description

Imiquimod (Aldara cream) will be applied nightly for four weeks after standard of care laser treatment for port wine stain.

Non-medicated petroleum cream will be applied nightly for four weeks after standard of care laser treatment for port wine stain.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00979550

First Posted

September 17, 2009

Last Updated

March 19, 2018

Sponsor

Henry Vasconez

Collaborators

Graceway Pharmaceuticals, LLC

1. Study Identification

Unique Protocol Identification Number

NCT00979550

Brief Title

The Effects of Aldara as an Adjunct to Laser Treatment

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Terminated

Why Stopped

Failure to enroll enough participants

Study Start Date

October 2008 (undefined)

Primary Completion Date

August 2013 (Actual)

Study Completion Date

August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Henry Vasconez

Collaborators

Graceway Pharmaceuticals, LLC

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Port Wine Stains

Keywords

laser, pediatric, skin pigmentation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

7 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Aldara cream

Arm Type

Experimental

Arm Description

Imiquimod (Aldara cream) will be applied nightly for four weeks after standard of care laser treatment for port wine stain.

Arm Title

non-medicated petroleum cream

Arm Type

Placebo Comparator

Arm Description

Non-medicated petroleum cream will be applied nightly for four weeks after standard of care laser treatment for port wine stain.

Intervention Type

Drug

Intervention Name(s)

Imiquimod

Other Intervention Name(s)

Aldara

Intervention Description

commercially available topical antiviral drug

Intervention Type

Drug

Intervention Name(s)

non-medicated petroleum cream

Intervention Description

Over the counter topical cream used to aid the healing process in skin lesions

Primary Outcome Measure Information:

Title

Effects of Aldera Cream on the Reduction of Port Wine Stain (Vascular Malformation)

Description

Lesions will be digitally photographed and its surface area measured by blinded observers using image analysis software

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Henry C. Vasconez, MD

Organizational Affiliation

University of Kentucky

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Kentucky Division of Plastic Surgery

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40536-0284

Country

United States

12. IPD Sharing Statement

Learn more about this trial

The Effects of Aldara as an Adjunct to Laser Treatment

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