Fractional CO2 Laser System (Fraxel Repair Laser) Intended for Treatment of Perioral Rhytides/Wrinkles

Wrinkle Clinical Trial

Official title:

Clinical Assessment of the Performance of a Fractional CO2 Laser System (Fraxel Repair Laser) Intended for Treatment of Perioral Rhytides/Wrinkles

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03715049
• Other study ID #: Fraxel Laser for Upper Lip
• Status: Completed
• Phase: N/A
• Start date: July 2013
• Est. completion date: December 2017

Study information

• Verified date: October 2018
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Wrinkle

Intervention

Procedure:
• Fraxel Laser Treatment
The device to be used in this study is a FDA approved device [510(k) approval] used for aesthetic dermatological procedures. The Fraxel Repair laser system utilizes a sealed off, all metal carbon dioxide gas tube that is radio frequency (RF) excited and air cooled, emitting light at a wavelength of 10.6 µm with programmable pulse duration and frequency. The Fraxel Repair laser has a continuous motion (rolling) optical tracking system. The Fraxel system consists of a treatment component and an internal control component. The treatment component consists of the laser delivery handpiece. A computer with a touch screen keyboard to enter subjects' information also provides controls for the fractionated delivery of the 10.6 µm beam.

Locations

Country	Name	City	State
United States	UT Southwestern Medical Center Dept. of Plastic Surgery	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center	Valeant Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the lip wrinkles from baseline to 1 month	The primary outcome measure of effectiveness will be a paired comparison of baseline to 1, 3, and 6 month follow-up ratings for wrinkles using a Merz Aesthetic Lip Line score (0 none 1-4). Safety will be defined as an absence of hypopigmentary changes and by a restoration of hyperpigmentary changes to mild or less at 1 month. Photographs of treated skin at follow-up visits will be compared to baseline to document the healing time course and may be used for blinded scoring evaluations (0-9 scales) of wrinkles, skin texture and color changes. The investigator will grade the epidermal response including side effects and adverse events using the 0 to 10 grading scale.	1 month
Primary	Change in lip wrinkle from baseline to 3 months	The primary outcome measure of effectiveness will be a paired comparison of baseline to 3 months ratings for wrinkles using a Merz Aesthetic Lip Line score (0 none 1-4). Safety will be defined as an absence of hypopigmentary changes and by a restoration of hyperpigmentary changes to mild or less at 3 month. Photographs of treated skin at follow-up visits will be compared to baseline to document the healing time course and may be used for blinded scoring evaluations (0-9 scales) of wrinkles, skin texture and color changes. The investigator will grade the epidermal response including side effects and adverse events using the 0 to 10 grading scale.	3 month
Primary	Change in the lip wrinkles from baseline to 6 month	The primary outcome measure of effectiveness will be a paired comparison of baseline to 6 month follow-up ratings for wrinkles using a Merz Aesthetic Lip Line score (0 none 1-4). Safety will be defined as an absence of hypopigmentary changes and by a restoration of hyperpigmentary changes to mild or less at 6 month. Photographs of treated skin at follow-up visits will be compared to baseline to document the healing time course and may be used for blinded scoring evaluations (0-9 scales) of wrinkles, skin texture and color changes. The investigator will grade the epidermal response including side effects and adverse events using the 0 to 10 grading scale.	6 month