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This study is a prospective, post-marketing (Phase 4) non-registrational single-arm, open-label, multicenter study.
Study to be conducted at approximately 6 investigative sites in the United States, enrolling up to 50 male and female participants with Fitzpatrick skin types I to VI, with no more 30 (60%) participants with Fitzpatrick skin types I to III and approximately 20 (40%) participants who self-identify as being of Asian descent
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fraxel® FTX Laser System | Device | The Fraxel Laser System has two fiber-laser sources that are contained in a single Console. The Console is electrically connected to the facility power source. Laser energy produced by the unit is delivered to the tissue through the Handpiece, which is connected to the Console by the Handpiece Cable. Treatments are delivered through removable, disposable Treatment Tips which attach to the Handpiece. A Treatment Key is required to activate treatments and is inserted into the port on the side of the Touchscreen. The system includes two lasers with wavelengths of 1550 nm and 1927 nm. The two-wavelength option allows for targeted treatment of different tissue depths, and the wavelength can be selected through the Console Touchscreen. Interchangeable Tips allow for treatment of both small and large areas. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Endpoint | Proportion of participants with any improvement after 3 treatments as assessed by Investigator Global Aesthetic Improvement Scale (iGAIS) at End of Study | 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Endpoint | The FACE-Q Satisfaction with Outcome domain will be administered at the EOS visit to evaluate participant-reported satisfaction following Fraxel FTX treatments. | 26 weeks |
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Inclusion Criteria:
Male or female.
21 to 60 years of age.
Written informed consent must be obtained prior to any study procedures.
Presence of one or more of the following in the treatment area(s):
Ability to read, understand, and sign the informed consent form
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatology Cosmetic Laser Associates of La Jolla, Inc. d/b/a West Dermatology Research Center | La Jolla | California | 92121 | United States |
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|
| Miami Dermatology & Laser Research LLC | Miami | Florida | 33133 | United States |
| Oak Dermatology, LLC | Naperville | Illinois | 60563 | United States |
| Union Square Laser Dermatology, P.C | New York | New York | 10003 | United States |
| Dermatology and Laser Surgery Center | Houston | Texas | 77004 | United States |