Skin ResurfacingNCT07214272
A Phase 4 Clinical Study to Investigate the Effectiveness and Safety of Skin Resurfacing
A study testing Fraxel® FTX Laser System in people with Skin Resurfacing, run by Bausch Health Americas, Inc. at 5 sites in United States.
Trial summary
This study is a prospective, post-marketing (Phase 4) non-registrational single-arm, open-label, multicenter study. Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Resurfacing
- What is being tested?
- Fraxel® FTX Laser System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 5 sitesUnited States
- Study dates
- 17 Oct 2025to 6 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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):
- Photodamage as determined by investigator using a Modified Griffith's Scale (score of 3 to 7 in overall photodamage on the 9-point scale)
- 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).
- 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).
- Ability to read, understand, and sign the informed consent form
Who cannot join
- Pregnant, breastfeeding, or planning to become pregnant during the study.
- History of any type of allergic reaction to topical anesthetics.
- Localized infection in the treatment area or systemic infection within the last 1 month prior to or at any time during the study.
- Presence of melasma, rosacea, significant actinic keratoses, or other significant skin conditions in the target treatment zone.
- 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.
- Presence of skin conditions that, in the judgement of the investigator, would increase the risk of study participation or treatment.
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- Predisposition to keloid formation or excessive scarring.
- Diagnosis of a condition that may compromise the immune system, such as: HIV, lupus, and/or scleroderma.
- Known sensitivity to light or photosensitizing agents/medications are being taken that the investigator determines may affect study treatment.
- 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.
- Use of topical retinoids within 2 weeks prior to enrollment or at any time during the study.
- Use of systemic retinoids within 6 months prior to enrollment or at any time during the study.
- 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.
- 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.
- Receiving dermal fillers administered to the targeted treatment zone within 3 months prior to enrollment or at any time during the study.
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Dermatology and Laser Surgery Center
Houston, Texas, 77004
Dermatology Cosmetic Laser Associates of La Jolla, Inc. d/b/a West Dermatology Research Center
La Jolla, California, 92121
Miami Dermatology & Laser Research LLC
Miami, Florida, 33133
Oak Dermatology, LLC
Naperville, Illinois, 60563
Union Square Laser Dermatology, P.C
New York, New York, 10003
About this study
Official title: A Phase 4 Clinical Study to Investigate the Effectiveness and Safety of Skin Resurfacing Procedures Using the Next Generation Fraxel® FTX Laser System in Participants With Dyschromia, Cutaneous Lesions, and Periorbital Rhytids
This study is a prospective, post-marketing (Phase 4) non-registrational single-arm, open-label, multicenter study.
Read the detailed description
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
- Conditions
- Skin Resurfacing
- Being tested
- Fraxel® FTX Laser System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fraxel® FTX Laser SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Not described Receives: Device: Fraxel® FTX Laser System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Endpoint
Proportion of participants with any improvement after 3 treatments as assessed by Investigator Global Aesthetic Improvement Scale (iGAIS) at End of Study
Measured: 26 weeks
Secondary outcomes (1)
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.
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2025
- Study start17 Oct 2025
- Primary completion24 Aug 2026
- Study completion6 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin ResurfacingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch Health Americas, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07214272
- Sponsor's protocol ID
- FX-PAS-USA-2024-001
- Status last verified
- Aug 2026
- First submitted
- 18 Sep 2025
- Last updated
- 28 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 4 Clinical Study to Investigate the Effectiveness and Safety of Skin Resurfacing Procedures Using the Next Generation Fraxel® FTX Laser System in Participants With Dyschromia, Cutaneous Lesions, and Periorbital Rhytids
- ClinicalTrials.gov ID
- NCT07214272
- Acronym / sponsor ID
- FX-PAS-USA-2024-001
- Conditions
- Skin Resurfacing
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Oct 2025 (actual)
- Primary completion
- 24 Aug 2026 (actual)
- Study completion
- 6 Oct 2026 (estimated)
- First posted
- 9 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a prospective, post-marketing (Phase 4) non-registrational single-arm, open-label, multicenter study.
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Device: Fraxel® FTX Laser System |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (16 listed)
- Pregnant, breastfeeding, or planning to become pregnant during the study.
- History of any type of allergic reaction to topical anesthetics.
- Localized infection in the treatment area or systemic infection within the last 1 month prior to or at any time during the study.
- Presence of melasma, rosacea, significant actinic keratoses, or other significant skin conditions in the target treatment zone.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fraxel® FTX Laser SystemThe 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. | Device | Treatment Arm |
Primary outcome
Primary Endpoint
Time frame: 26 weeks
Proportion of participants with any improvement after 3 treatments as assessed by Investigator Global Aesthetic Improvement Scale (iGAIS) at End of Study
1 secondary outcome
Secondary Endpoint
Time frame: 26 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fraxel® FTX Laser System in people with Skin Resurfacing, run by Bausch Health Americas, Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Endpoint (time frame: 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.