Laser Spot Treatment of Perioral Rhytids

Facial Aging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01986634
• Other study ID #: 01-13-12
• Status: Completed
• Phase: N/A
• Start date: September 2013
• Est. completion date: December 31, 2015

Study information

• Verified date: June 2023
• Source: University Hospitals Cleveland Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 31, 2015
• Est. primary completion date: August 31, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Facial Aging

Intervention

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.

Locations

Country	Name	City	State
United States	Univeristy Hospitals Cedar Brainard Office	Lyndhurst	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University Hospitals Cleveland Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time to healing after laser resurfacing	Each side of the face will be assessed for time to healing.	2-3 weeks