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

This study has been completed.

Sponsor:

Information provided by:

Plastic Surgery Educational Foundation

ClinicalTrials.gov Identifier:

NCT01113606

First received: April 28, 2010

Last updated: April 29, 2010

Last verified: April 2010

History of Changes

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.

Resource links provided by NLM:

Drug Information available for: Hydroquinone Metronidazole Metronidazole benzoate Metronidazole hydrochloride

U.S. FDA Resources

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

Ages Eligible for Study:	18 Years to 65 Years
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier:	NCT01113606 History of Changes
Other Study ID Numbers:	PSEF001-06
Study First Received:	April 28, 2010
Last Updated:	April 29, 2010
Health Authority:	United States: Institutional Review Board

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
Hydroquinone
Radiation-Protective Agents

Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013

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