Laser Spot Treatment of Perioral Rhytids

NCT01986634 | Completed

• 1 other identifier: 01-13-12
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Facial Aging

Keywords

Laser Resurfacing; Rhytids; Perioral

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Time to healing after laser resurfacing

  2-3 weeks

Study Arms (1)

Laser Treatment

OTHER

Patients enrolled will have split face laser treatment. Patients will serve as their own control.

Procedure: Laser Treatment

Interventions

Laser Treatment PROCEDURE

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.

Laser Treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients undergoing additional invasive cosmetic procedure at the same time including rhytidectomy, fat injection
• History of Photosensitvity
• Use of photosenstive medications
• History of keloid or hypertrophic scarring
• Use of Isotretinoin in the previous year
• Previous resurfacing procedure (laser or chemical peel) within the previous 6 months

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (1)

Univeristy Hospitals Cedar Brainard Office

Lyndhurst, Ohio, 44124, United States

Location

MeSH Terms

Interventions

Laser Therapy

Intervention Hierarchy (Ancestors)

Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• David J Rowe, MD

  University Hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2013
• First Posted: November 18, 2013
• Study Start: September 1, 2013
• Primary Completion: August 31, 2014
• Study Completion: December 31, 2015
• Last Updated: July 5, 2023

Record last verified: 2023-06

Locations

US (1)