Clinical trial NCT03715049: Fractional CO2 Laser System (Fraxel Repair Laser) Intended for Treatment of Perioral Rhytides/Wrinkles
Official title: Clinical Assessment of the Performance of a Fractional CO2 Laser System (Fraxel Repair Laser) Intended for Treatment of Perioral Rhytides/Wrinkles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wrinkle
Keywords: upper lip wrinkles
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: Valeant Pharmaceuticals
First posted: 2018-10-22
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Objective 1: To evaluate the effect and histologic (cellular) changes associated with varying energy and density settings of the Fraxel Repair Laser to determine an optimal dose response.

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 photos. The subject's assessment of satisfaction will be characterized using a non-parametric assessment scale at each follow-up period.

Detailed description: 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 photos. The subject's assessment of satisfaction will be characterized using a non-parametric assessment scale at each follow-up period.

This is a multi-site, 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.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* Subjects with active localized or systemic infections.
* Immunocompromised subjects.
* Subjects with coagulation disorder.
* History of skin photo sensitivity disorders, or use of photosensitizing drugs (e.g., tetracycline or sulfa drugs).
* Pregnant and/or lactating (All female volunteers will be advised about using birth control during the period of study).
* In the opinion of the trained clinician, subject is unwilling or unable to adhere to all study requirements, including application and follow-up visits.
* Use of Accutane® within the past 6 months.
* Subjects with a history of radiation therapy to the treatment area.
* Subject has a history of allergy to lidocaine or ester-based local anesthetics.
* Subjects with any skin pathology or condition that could interfere with evaluation or with the use of typical ancillary medical treatments or care used before, during or after treatments.
* Subjects have undergone dermatological procedures (e.g., laser or light treatments) for the treatment of wrinkles, skin resurfacing, or skin rejuvenation in the treatment area within 1 year of study participation.

Primary outcomes:
measure: Change in the lip wrinkles from baseline to 1 month
timeFrame: 1 month
measure: Change in lip wrinkle from baseline to 3 months
timeFrame: 3 month
measure: Change in the lip wrinkles from baseline to 6 month
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center Dept. of Plastic Surgery
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Jeffrey M. Kenkel, MD
role: PRINCIPAL_INVESTIGATOR
References: