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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01113606
First Posted: April 30, 2010
Last Update Posted: April 30, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Plastic Surgery Educational Foundation
  Purpose
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.

Condition Intervention Phase
Facial Photo Damage Periocular Fine Wrinkles Perioral Fine Wrinkles Other: Obagi New-Derm System Other: Standard of Care Phase 4

Study Type: Interventional
Official Title: 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.

Further study details as provided by Plastic Surgery Educational Foundation:

Arms Assigned Interventions
Active Comparator: Obagi Nu-Derm System (ONDS) Other: Obagi New-Derm System
Active Comparator: Standard of Care Other: Standard of Care

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01113606


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

ClinicalTrials.gov Identifier: NCT01113606     History of Changes
Other Study ID Numbers: PSEF001-06
First Submitted: April 28, 2010
First Posted: April 30, 2010
Last Update Posted: April 30, 2010
Last Verified: April 2010

Keywords provided by Plastic Surgery Educational Foundation:
Moderate to severe facial photo damage
Periocular or perioral fine wrinkles

Additional relevant MeSH terms:
Facies
Disease Attributes
Pathologic Processes