Clinical Assessment of the Performance of a Fractional CO2 Laser System (Fraxel Repair Laser) intended for treatment of perioral rhytides/wrinkles

Study ID
STU 032013-003

Cancer Related
No

Healthy Volunteers
Yes

Study Sites

  • UT Southwestern-Other
  • UT Southwestern University Hospital—St. Paul
  • UT Southwestern University Hospital– Zale Lipshy

Contact
Jessica Harper
214-645-3967
jessica.harper@utsouthwestern.edu

Principal Investigator
Jeffrey Kenkel

Summary

objective 1: To evaluate the effect and histologic changes associated with varying energy and density settings of the Fraxel Repair Laser to determine an optimal dose response.
Pre-Clinical Study
This pre-clinical stage will enable us to narrow the range of settings on the Fraxel laser device that will be applied during the clinical portion of our study.
abdominoplasty: Five (5) healthy adults (male and female), 21 to 80 years of age, who are scheduled to undergo abdominoplasty (where abdominal skin will be excised) will be recruited from the investigators' patient populations. informed Consent will be obtained from each subject during a pre-operative visit.

after initial analysis of data on the abdominoplasty subjects, an additional group of five (5) patients undergoing facial reconstruction whereby facial skin will be discarded as part of the repair will be enrolled. excess skin to be excised will be treated with the Fraxel Repair Laser to correlate the preclinical findings to facial skin.
Facial Reconstruction: Five (5) healthy adults (male and female), 21 to 80 years of age, who are scheduled to undergo facial tissue excision (secondary to flap reconstruction of the face) will be recruited from the the investigators' patient populations. informed Consent will be obtained from each subject during a pre-operative visit.

analysis of the results from observation and testing of the pre-clinical samples will inform the range of settings that will be applied during the clinical portion of the study.
objective 2: To evaluate the clinical response associated with variable energy and density settings of fraxel laser treatment in the upper lip. overall assessment of clinical outcome and safety will be based clinic visits and evaluation of pre- and post- procedural images. The subject's assessment of satisfaction will be characterized using a non-parametric assessment scale at each follow-up period.
From these studies the relationships among the energy densities can be correlated with treatment depths and clinical 'down time' of subjects. With the ablative (removal of the epidermis) treatment, the ablative energy will be correlated to cellular changes in skin cells and collagen changes and ablative depth. in addition, subject satisfaction to the indicated clinical outcome will be assessed.
Clinical Study
Fraxel Treatment of Perioral Wrinkles/Rhytides of the upper Lip
This is a multi-center, non-randomized, non-controlled investigator initiated study designed to follow a total of 30 qualified and consenting subjects treated with one Fraxel Repair treatment in the course of clinical practice.

using the energy and density settings within the FDa approved limits (5-40mJ at 30-100% density) that were narrowed down by the pre-clinical portion of the study, up to thirty (30) subjects will be recruited and treated one (1) time in the perioral region of the upper lip and followed for 6 months (study design below). The acute effects of the laser application will be determined by subjective analysis using the wrinkle severity scores.

Participant Eligibility

Inclusion criteria: (Objectives 1 & 2)

* Healthy male and female adults between 18-75 years of age.

* Subjects who can read, understand, and sign the Informed Consent Form.

* Subjects willing and able to comply with all study requirements.

* Fitzpatrick skin type I-IV (Although the systems are cleared for all skin types I- VI, it is recommended to use the Matrix applicators on skin types I- V).

* (Objective 1 Only) - Subjects who have pre-scheduled a body or facial contouring procedure.