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The Effects of Aldara as an Adjunct to Laser Treatment

2014-08-27 03:19:16 | BioPortfolio

Summary

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

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.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Port Wine Stains

Intervention

Imiquimod (Aldara), non-medicated petroleum cream

Location

University of Kentucky Division of Plastic Surgery
Lexington
Kentucky
United States
40536-0284

Status

Recruiting

Source

University of Kentucky

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:19:16-0400

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Medical and Biotech [MESH] Definitions

A vascular malformation of developmental origin characterized pathologically by ectasia of superficial dermal capillaries, and clinically by persistent macular erythema. In the past, port wine stains have frequently been termed capillary hemangiomas, which they are not; unfortunately this confusing practice persists: HEMANGIOMA, CAPILLARY is neoplastic, a port-wine stain is non-neoplastic. Port-wine stains vary in color from fairly pale pink to deep red or purple and in size from a few millimeters to many centimeters in diameter. The face is the most frequently affected site and they are most often unilateral. (From Rook et al., Textbook of Dermatology, 5th ed, p483)

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PHENOTHIAZINES with an amino group at the 3-position that are green crystals or powder. They are used as biological stains.

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Antigenic characteristics and DNA fingerprint patterns identified from blood stains. Their primary value is in criminal cases.

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