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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01113606
Other study ID # PSEF001-06
Secondary ID
Status Completed
Phase Phase 4
First received April 28, 2010
Last updated April 29, 2010

Study information

Verified date April 2010
Source Plastic Surgery Educational Foundation
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Female
Age group 18 Years to 65 Years
Eligibility 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 Design

N/A


Intervention

Other:
Obagi New-Derm System

Standard of Care


Locations

Country Name City State
United States Aesthetic and Plastic Surgery Institute Greeley Colorado
United States Advanced Cosmetis Surgery Greenville South Carolina
United States Kentucky Aesthetic and Plastic Surgery Institute Louisville Kentucky
United States Brevard Plastic Surgery and Skin Institute Melbourne Florida
United States Suite 135 Oxnard California
United States Suite 175 Rancho Santa Margarita California
United States Body Aesthetic Plastic Surgery St. Louis Missouri
United States Center for Plastic and Reconstructive Surgery Ypsilanti Michigan

Sponsors (1)

Lead Sponsor Collaborator
Plastic Surgery Educational Foundation

Country where clinical trial is conducted

United States,