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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
Sponsor:
Information provided by (Responsible Party):
David J. Rowe MD., University Hospitals Cleveland Medical Center

Brief Summary:

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

Detailed Description:

Cohort Study, with Split Face treatment

Methods:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rashes

Arm Intervention/treatment
Laser Treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Time to healing after laser resurfacing [ Time Frame: 2-3 weeks ]
    Each side of the face will be assessed for time to healing.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patient who are electively presenting to the plastic surgery department for evaluation and treatment of facial aging and elect/seek to have laser treatment will be asked to voluntarily participate in the study.

Fitzpatrick type 1-4 skin

Exclusion Criteria:

1 Patients undergoing additional invasive cosmetic procedure at the same time including rhytidectomy, fat injection

2 History of Photosensitvity

3 Use of photosenstive medications

4 History of keloid or hypertrophic scarring

5 Use of Isotretinoin in the previous year

6 Previous resurfacing procedure (laser or chemical peel) within the previous 6 months


Information from the National Library of Medicine

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


Contacts
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Contact: Matthew S Brown, MD matthew.brown@uhhospitals.org
Contact: David J Rowe, MD

Locations
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United States, Ohio
Univeristy Hospitals Cedar Brainard Office
Lyndhurst, Ohio, United States, 44124
Contact: Matthew S Brown, MD    440-446-0222    matthew.brown@uhhospitals.org   
Principal Investigator: David Rowe, MD         
Sponsors and Collaborators
University Hospitals Cleveland Medical Center
Investigators
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Principal Investigator: David J Rowe, MD University Hospitals
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Responsible Party: David J. Rowe MD., Assistant Department of Plastic Surgery, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT01986634    
Other Study ID Numbers: 01-13-12
First Posted: November 18, 2013    Key Record Dates
Last Update Posted: November 18, 2013
Last Verified: November 2013
Keywords provided by David J. Rowe MD., University Hospitals Cleveland Medical Center:
Laser Resurfacing
Rhytids
Perioral