Laser Spot Treatment of Perioral Rhytids

Efficacy of Spot Treatment of Perioral Rhytids Compared to Full Field Laser Resurfacing

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.

Study Overview

• Status: Completed
• Conditions: Facial Aging
• Intervention / Treatment: Procedure: Laser Treatment

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Lyndhurst, Ohio, United States, 44124
      • Univeristy Hospitals Cedar Brainard Office

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Laser Treatment; Patients enrolled will have split face laser treatment. Patients will serve as their own control.	Procedure: Laser Treatment; Patient will have split face laser resurfacing as per standard of care. 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in perioral rhytids	at 3 and 6 month post-operative visits, photographs will be taken and analyzed for improvement in rhytids.	3-6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to healing after laser resurfacing	Each side of the face will be assessed for time to healing.	2-3 weeks

Collaborators and Investigators

• Sponsor: University Hospitals Cleveland Medical Center
• Investigators: Principal Investigator: David J Rowe, MD, University Hospitals

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): August 31, 2014
• Study Completion (Actual): December 31, 2015

Study Registration Dates

• First Submitted: November 11, 2013
• First Submitted That Met QC Criteria: November 11, 2013
• First Posted (Estimated): November 18, 2013

Study Record Updates

• Last Update Posted (Actual): July 5, 2023
• Last Update Submitted That Met QC Criteria: June 30, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Perioral; Rhytids; Laser Resurfacing
• Other Study ID Numbers: 01-13-12