Clinical trial NCT01986634: Laser Spot Treatment of Perioral Rhytids
Official title: Efficacy of Spot Treatment of Perioral Rhytids Compared to Full Field Laser Resurfacing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Facial Aging
Keywords: Laser Resurfacing
Rhytids
Perioral
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
First posted: 2013-11-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Improvement in perioral rhytids
timeFrame: 3-6 months
Secondary outcomes:
measure: Time to healing after laser resurfacing
timeFrame: 2-3 weeks
Other outcomes:
Locations:
city: Lyndhurst
country: United States
facility: Univeristy Hospitals Cedar Brainard Office
state: Ohio
Study officials:
affiliation: University Hospitals
name: David J Rowe, MD
role: PRINCIPAL_INVESTIGATOR
References: