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A Trial of Skin Care Protocols for Facial Resurfacing

NCT ID: NCT01113606

Last Updated: 2010-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Facial Photo Damage Periocular Fine Wrinkles Perioral Fine Wrinkles

Keywords

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Moderate to severe facial photo damage Periocular or perioral fine wrinkles

Study Groups

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Obagi Nu-Derm System (ONDS)

Group Type ACTIVE_COMPARATOR

Obagi New-Derm System

Intervention Type OTHER

Standard of Care

Group Type ACTIVE_COMPARATOR

Standard of Care

Intervention Type OTHER

Interventions

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Obagi New-Derm System

Intervention Type OTHER

Standard of Care

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The Plastic Surgery Foundation

OTHER

Sponsor Role lead

Locations

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Suite 135

Oxnard, California, United States

Site Status

Suite 175

Rancho Santa Margarita, California, United States

Site Status

Aesthetic and Plastic Surgery Institute

Greeley, Colorado, United States

Site Status

Brevard Plastic Surgery and Skin Institute

Melbourne, Florida, United States

Site Status

Kentucky Aesthetic and Plastic Surgery Institute

Louisville, Kentucky, United States

Site Status

Center for Plastic and Reconstructive Surgery

Ypsilanti, Michigan, United States

Site Status

Body Aesthetic Plastic Surgery

St Louis, Missouri, United States

Site Status

New York, New York, United States

Site Status

Advanced Cosmetis Surgery

Greenville, South Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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PSEF001-06

Identifier Type: -

Identifier Source: org_study_id