The Effects of Aldara as an Adjunct to Laser Treatment

NCT00979550 | Terminated Phase 2 Results

• 1 other identifier: UK Aldara
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Port Wine Stains

Keywords

laser; pediatric; skin pigmentation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Aldara cream

EXPERIMENTAL

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

Drug: Imiquimod

non-medicated petroleum cream

PLACEBO COMPARATOR

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

Drug: non-medicated petroleum cream

Interventions

Imiquimod DRUG

commercially available topical antiviral drug

Also known as: Aldara

Aldara cream

non-medicated petroleum cream DRUG

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

non-medicated petroleum cream

Eligibility Criteria

• Age: 2 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Henry Vasconez: lead
• Graceway Pharmaceuticals, LLC: collaborator

Study Sites (1)

University of Kentucky Division of Plastic Surgery

Lexington, Kentucky, 40536-0284, United States

Location

MeSH Terms

Conditions

Hemangioma, Capillary; Pigmentation Disorders

Interventions

Imiquimod

Condition Hierarchy (Ancestors)

Hemangioma; Neoplasms, Vascular Tissue; Neoplasms by Histologic Type; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Henry C. Vasconez, MD
• Organization: University of Kentucky Healthcare

betsy.fink@uky.edu

8593236328

Study Officials

• Henry C. Vasconez, MD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: principal Investigator

Study Record Dates

• First Submitted: September 17, 2009
• First Posted: September 18, 2009
• Study Start: October 1, 2008
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: March 22, 2018
• Results First Posted: March 22, 2018

Record last verified: 2018-03

Locations

US (1)