Trials Sponsors Conditions Drugs Pricing

Conditions

Port Wine Stains

Keywords

laserpediatricskin 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

ImiquimodDrug

commercially available topical antiviral drug

Also known as: Aldara

Aldara cream

non-medicated petroleum creamDrug

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

non-medicated petroleum cream

Eligibility Criteria

Age2 Years - 60 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (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.

Sponsors & Collaborators

Henry Vasconez
Otherlead
Graceway Pharmaceuticals, LLC
Industrycollaborator

Study Sites (1)

University of Kentucky Division of Plastic Surgery

Lexington, Kentucky, 40536-0284, United States

MeSH Terms

Conditions

Hemangioma, CapillaryPigmentation Disorders

Interventions

Imiquimod

Condition Hierarchy (Ancestors)

HemangiomaNeoplasms, Vascular TissueNeoplasms by Histologic TypeNeoplasmsSkin DiseasesSkin and Connective Tissue DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aminoquinolines

Results Point of Contact

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

Study Officials

Henry C. Vasconez, MD
University of Kentucky
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

7 participants (actual enrollment reported by the registry).

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 2008

Date type not reported

This date has not been verified as actual or estimated.

Study Stopped

The Effects of Aldara as an Adjunct to Laser Treatment

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Aldara cream

non-medicated petroleum cream

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Aldara cream

non-medicated petroleum cream

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations