A Trial of Skin Care Protocols for Facial Resurfacing (SPAR)

April 29, 2010 updated by: The Plastic Surgery Foundation

A Double-Blind, Randomized, Controlled Trial to Assess the Effects of the Obagi Nu-Derm System on Re-Epithelialization After Chemical Peel or Ablative Laser Resurfacing.

The aims of the Skin Product Assessment Research study were to (1) develop an infrastructure and process for industry-sponsored, Plastic Surgery Educational Foundation (PSEF) research in facial aesthetic surgery and (2) test the research process by comparing outcomes of the Obagi Nu-Derm System (ODNS) and conventional therapy as treatment adjuncts in ablative facial resurfacing.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Oxnard, California, United States, 93030
        • Suite 135
      • Rancho Santa Margarita, California, United States, 92688
        • Suite 175
    • Colorado
      • Greeley, Colorado, United States, 80634
        • Aesthetic and Plastic Surgery Institute
    • Florida
      • Melbourne, Florida, United States, 32901
        • Brevard Plastic Surgery and Skin Institute
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Kentucky Aesthetic and Plastic Surgery Institute
    • Michigan
      • Ypsilanti, Michigan, United States, 48197
        • Center for Plastic and Reconstructive Surgery
    • Missouri
      • St. Louis, Missouri, United States, 63141
        • Body Aesthetic Plastic Surgery
    • New York
      • New York, New York, United States
    • South Carolina
      • Greenville, South Carolina, United States, 29607
        • Advanced Cosmetis Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • patients with moderate to severe photo damage and rhytids, undergoing full or partial face resurfacing with chemical peel or ablative laser.
  • Fitzpatrick I-IV skin types

Exclusion Criteria:

  • patients unable to complete the regimen or who had used topical prescription steroids, retinoids, depigmentation products or other products containing hydroquinone and polyhydroxy acids within 8 weeks of enrollment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard of Care
Other: Standard of Care
Active Comparator: Obagi Nu-Derm System (ONDS)
Other: Obagi New-Derm System

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Plastic Surgery Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

April 28, 2010

First Submitted That Met QC Criteria

April 29, 2010

First Posted (Estimate)

April 30, 2010

Study Record Updates

Last Update Posted (Estimate)

April 30, 2010

Last Update Submitted That Met QC Criteria

April 29, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSEF001-06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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