Facial Photo DamagePhase 4SPARNCT01113606
A Trial of Skin Care Protocols for Facial Resurfacing
A Phase 4 study testing Obagi New-Derm System in people with Facial Photo Damage and Periocular Fine Wrinkles, run by The Plastic Surgery Foundation at 9 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Facial Photo Damage, Periocular Fine Wrinkles, Perioral Fine Wrinkles
- What is being tested?
- Obagi New-Derm System
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 9 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Aesthetic and Plastic Surgery Institute
Greeley, Colorado, 80634
Advanced Cosmetis Surgery
Greenville, South Carolina, 29607
Kentucky Aesthetic and Plastic Surgery Institute
Louisville, Kentucky, 40202
Brevard Plastic Surgery and Skin Institute
Melbourne, Florida, 32901
Study site
New York, New York
Suite 135
Oxnard, California, 93030
Suite 175
Rancho Santa Margarita, California, 92688
Body Aesthetic Plastic Surgery
St Louis, Missouri, 63141
Center for Plastic and Reconstructive Surgery
Ypsilanti, Michigan, 48197
About this study
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.
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.
- Being tested
- Obagi New-Derm System, Standard of Care
- Keywords
- Moderate to severe facial photo damage, Periocular or perioral fine wrinkles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obagi New-Derm SystemOther
Standard of CareOther
| Study group | Role | What they receive |
|---|---|---|
| Obagi Nu-Derm System (ONDS) | Active comparator | Not described Receives: Other: Obagi New-Derm System |
| Standard of Care | Active comparator | Not described Receives: Other: Standard of Care |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial Photo DamageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
Sponsor and investigators
- Lead sponsor
- The Plastic Surgery Foundation
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01113606
- Sponsor's protocol ID
- PSEF001-06
- Acronym
- SPAR
- Status last verified
- Apr 2010
- First submitted
- 28 Apr 2010
- Last updated
- 30 Apr 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01113606
- Acronym / sponsor ID
- SPAR / PSEF001-06
- Keywords
- Moderate to severe facial photo damage, Periocular or perioral fine wrinkles
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- The Plastic Surgery FoundationUniversity, hospital or other
- First posted
- 30 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obagi Nu-Derm System (ONDS) | Active comparator | Other: Obagi New-Derm System |
| Standard of Care | Active comparator | Other: Standard of Care |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Obagi New-Derm System | Other | Obagi Nu-Derm System (ONDS) |
| Standard of Care | Other | Standard of Care |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2010.
Related trials for Facial Photo Damage
RecruitingObservational study
OCTA Evaluated the Efficacy of Glucocorticoid Retrobulbar Injection in Retinal Photo-injury
Retinal Light Damage, Photic Retinopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Obagi New-Derm System in people with Facial Photo Damage and Periocular Fine Wrinkles, run by The Plastic Surgery Foundation at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2010.