A Phase 4 Clinical Study to Investigate the Effectiveness and Safety of Skin Resurfacing
NCT ID: NCT07214272
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2025-10-17
2026-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment Arm
Fraxel® FTX Laser System
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.
Interventions
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Fraxel® FTX Laser System
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.
Eligibility Criteria
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Inclusion Criteria
2. 21 to 60 years of age.
3. Written informed consent must be obtained prior to any study procedures.
4. Presence of one or more of the following in the treatment area(s):
1. Photodamage as determined by investigator using a Modified Griffith's Scale (score of 3 to 7 in overall photodamage on the 9-point scale)
2. Mild-to-moderate rhytids (e.g., periorbital crow's feet) as determined by investigator using a Modified Griffith's Scale (score of 3 to 6 on the 9-point scale).
3. Mild-to-severe dyschromia, including lentigos or solar lentigines as determined by investigator using the Modified Griffith's Scale (score of 3 to 9 on the 9-point scale).
5. Ability to read, understand, and sign the informed consent form
Exclusion Criteria
2. History of any type of allergic reaction to topical anesthetics.
3. Localized infection in the treatment area or systemic infection within the last 1 month prior to or at any time during the study.
4. Presence of melasma, rosacea, significant actinic keratoses, or other significant skin conditions in the target treatment zone.
5. Presence of skin cancer, infection, cold sore, open wounds, burns, psoriasis, or active dermatitis of any kind (atopic, contact, significant seborrheic dermatitis) in the target treatment zone.
6. Presence of skin conditions that, in the judgement of the investigator, would increase the risk of study participation or treatment.
7. Predisposition to keloid formation or excessive scarring.
8. Diagnosis of a condition that may compromise the immune system, such as: HIV, lupus, and/or scleroderma.
9. Known sensitivity to light or photosensitizing agents/medications are being taken that the investigator determines may affect study treatment.
10. Use of systemic steroids (e.g. prednisone, dexamethasone) or other immunosuppressants within 1 month prior to enrollment to or at any time during the study.
11. Use of topical retinoids within 2 weeks prior to enrollment or at any time during the study.
12. Use of systemic retinoids within 6 months prior to enrollment or at any time during the study.
13. Had a cosmetic procedure, such as a chemical peel, mechanical peel, laser resurfacing, and/or skin tightening procedures (microneedling, ultrasound, etc.) within the previous 4 months prior to enrollment.
14. Receiving short-acting botulinum toxin within 4 months or long-acting botulinum toxin administered to the targeted treatment zone within 9 months prior to enrollment or at any time during the study.
15. Receiving dermal fillers administered to the targeted treatment zone within 3 months prior to enrollment or at any time during the study.
16. Sunburn and/or significant recent sun exposure on the target treatment zone in the last 2 weeks prior to enrollment that, according to investigator judgement, would impact treatment, and/or unwilling to practice photoprotection and/or avoid significant sun exposure for the duration of study participation.
21 Years
60 Years
ALL
Yes
Sponsors
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Bausch Health Americas, Inc.
INDUSTRY
Responsible Party
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Locations
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Dermatology Cosmetic Laser Associates of La Jolla, Inc. d/b/a West Dermatology Research Center
La Jolla, California, United States
Miami Dermatology & Laser Research LLC
Miami, Florida, United States
Oak Dermatology, LLC
Naperville, Illinois, United States
Union Square Laser Dermatology, P.C
New York, New York, United States
Dermatology and Laser Surgery Center
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Role: backup
Other Identifiers
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FX-PAS-USA-2024-001
Identifier Type: -
Identifier Source: org_study_id
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