Laser Spot Treatment of Perioral Rhytids
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01986634|
Recruitment Status : Unknown
Verified November 2013 by David J. Rowe MD., University Hospitals Cleveland Medical Center.
Recruitment status was: Not yet recruiting
First Posted : November 18, 2013
Last Update Posted : November 18, 2013
Perioral rhytides present a difficult problem in facial rejuvenation. They cannot be addressed with rhytidectomy (face lift) and direct excision can leave visible unfavorable scars. Currently, fine static wrinkles are most effectively treated with facial resurfacing, usually with laser treatment. Often the peri-oral area is treated with additional spot treatments with an ablative laser to cause a more robust healing response and better aesthtic result. To date, no studies have specifically shown efficacy of additional spot treatment over full facial laser alone.
This study is designed as a split-face study, to compare the aesthetic results of full field laser resurfacing on one half of the face with that of spot treatment of perioral rhytides on the other half.
To clarify further to the IRB board, this is not an experimental treatment. Spot treatment is used by many surgeons/laser proceduralists for addressing specific areas of the face. This is an FDA indicated use of the laser for facial resurfacing. Due to the many genetic and enviromental factors that can effect the results the best design for the study to is have each patient serve as their own control with a split-face study.
|Condition or disease||Intervention/treatment||Phase|
|Facial Aging||Device: Laser Treatment||Phase 3|
Cohort Study, with Split Face treatment
Patients will be evaluated in the office for possible inclusion. Those who agree to partipate will receive preoperative photos.
On the day of the procedure patients will have a topical anesthestic applied for 30 minutes, then patients will recieve a 20um laser resurfacing of the entire face to remove dead skin and debris. After that, patients will have reapplication of a topical anesthetic for an additional 10 minutes. They will then undergo a 50 um peel to one side of the face and a patient tailored spot treatment of perioral wrinkles to the other side of the face. The depth of this may vary from 100 to 400um.
Patients will return to clinic at 1 week, 2 weeks, and 3 weeks post-procedure and fill out a short survey and have medical photography done. Patients will return at 3 and 6 month follow-up for additional photography and surveys. These visits will typically take 10 to 20 minutes.
Preoperative and post-operative photos will be analyzed by 2 independent plastic surgeons for post-operative changes and improvements.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Efficacy of Spot Treatment of Perioral Rhytids Compared to Full Field Laser Resurfacing|
|Study Start Date :||September 2013|
|Estimated Primary Completion Date :||April 2014|
|Estimated Study Completion Date :||December 2015|
Patients enrolled will have split face laser treatment. Patients will serve as their own control.
Device: Laser Treatment
Patient will have split face laser resurfacing. One side of the face will be treated with a standardized single depth laser peel. The other side of the perioral area will be treated with variant, deeper treatment to perioral rhytids.
- Improvement in perioral rhytids [ Time Frame: 3-6 months ]at 3 and 6 month post-operative visits, photographs will be taken and analyzed for improvement in rhytids.
- Time to healing after laser resurfacing [ Time Frame: 2-3 weeks ]Each side of the face will be assessed for time to healing.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01986634
|Contact: Matthew S Brown, MDfirstname.lastname@example.org|
|Contact: David J Rowe, MD|
|United States, Ohio|
|Univeristy Hospitals Cedar Brainard Office|
|Lyndhurst, Ohio, United States, 44124|
|Contact: Matthew S Brown, MD 440-446-0222 email@example.com|
|Principal Investigator: David Rowe, MD|
|Principal Investigator:||David J Rowe, MD||University Hospitals|