NCT01113606

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 30, 2010

Completed
Last Updated

April 30, 2010

Status Verified

April 1, 2010

First QC Date

April 28, 2010

Last Update Submit

April 29, 2010

Conditions

Facial Photo DamagePeriocular Fine WrinklesPerioral Fine Wrinkles

Keywords

Moderate to severe facial photo damagePeriocular or perioral fine wrinkles

Study Arms (2)

Obagi Nu-Derm System (ONDS)

ACTIVE COMPARATOR
Other: Obagi New-Derm System

Standard of Care

ACTIVE COMPARATOR
Other: Standard of Care

Interventions

Obagi New-Derm SystemOTHER
Obagi Nu-Derm System (ONDS)
Standard of CareOTHER
Standard of Care

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Suite 135

Oxnard, California, 93030, United States

Location

Suite 175

Rancho Santa Margarita, California, 92688, United States

Location

Aesthetic and Plastic Surgery Institute

Greeley, Colorado, 80634, United States

Location

Brevard Plastic Surgery and Skin Institute

Melbourne, Florida, 32901, United States

Location

Kentucky Aesthetic and Plastic Surgery Institute

Louisville, Kentucky, 40202, United States

Location

Center for Plastic and Reconstructive Surgery

Ypsilanti, Michigan, 48197, United States

Location

Body Aesthetic Plastic Surgery

St Louis, Missouri, 63141, United States

Location

Unknown Facility

New York, New York, United States

Location

Advanced Cosmetis Surgery

Greenville, South Carolina, 29607, United States

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Design

Study Type
interventional
Phase
phase 4
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 28, 2010

First Posted

April 30, 2010

Last Updated

April 30, 2010

Record last verified: 2010-04

Locations

US(9)