Photodamaged SkinNCT07222397
2910 nm Erbium-Doped Fluoride Fiber Glass Laser for the Treatment of Advanced Perioral Lines and Wrinkles
A study testing Laser Resurfacing in people with Photodamaged Skin and Rhytids, run by FA Corporation at 1 site in United States.
Trial summary
The primary objective is to assess the efficacy, safety and satisfaction associated with the resurfacing treatment of perioral lines and wrinkles with the 2,910 nm mid-infrared Fiber Laser (UltraClear, Acclaro Medical) using both superficial epidermis ablation capabilities and the deep ablative and coagulative… Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Photodamaged Skin, Rhytids, Lines Skin
- What is being tested?
- Laser Resurfacing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2025to Feb 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fitzpatrick skin type I-IV.
- Male or female.
- Subjects must be between 50 and 80 years of age.
- Subjects must have the ability to receive up to two full face resurfacing laser treatment with specific focus on advanced perioral lines and wrinkles.
- Subjects must read, understand, and sign the Informed Consent Form.
- Subjects must be willing and able to comply with all follow-up visit requirements.
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- Subjects must agree to refrain from using cosmeceutical agents or topical agents during the study, except as directed by study investigator.
- Subjects must be rated as Class II or Class III based on the Fitzpatrick Wrinkling and Degree of Elastosis Scale (FWS).
- Subject identified as an appropriate candidate for study treatment based on principal investigator's opinion.
- Subjects of childbearing potential have been on an acceptable form of contraception for 30 days prior to enrollment and agree to continue using throughout the course of the study.
Who cannot join
- Subjects must not have active localized or systemic infections.
- Subjects must not have a compromised ability for wound healing, such as: malnutrition, steroid use, history of collagen vascular disease (e.g., lupus, scleroderma, history of keloid scar formation), atrophic dermatitis or immunologic abnormalities such as vitiligo.
- Subjects must not have had treatments with 5FU, diclofenac, imiquimod, steroids, retinoids, or PDT within 1-month prior to enrollment.
- Subjects must not currently be taking Accutane or have taken Accutane within the last 1-month.
- Subjects must not have a known allergy to lidocaine or epinephrine, topical or injectable products containing lidocaine or any numbing medications.
- Subjects must not have had previous surgery and/or fat transfer in the treatment area within the last 6-months.
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- Subject must not have had injectable soft tissue fillers within the last 12 months in the treatment area.
- Subject must not have had Poly-L-Lactic acid (PLLA) fillers within the last 2 years in the treatment area.
- Subject must not have had permanent filler i.e., Polymethylmethacrylate (PMMA) in the treatment area.
- Subjects must not have had neurotoxins within the last 3-months in the treatment area.
- Subject must not have a personal history of any facial threads i.e., PDO (Polydioxanone), PLLA (Polylactic acid), PCL (Polycaprolactone) in the treatment area within the last 12 months.
- Subject must not have had a pulse dye or vascular laser, non-ablative laser, microneedling, or energy-based device treatment in the treatment area within the last 3 months.
- Subject must not have had an ablative laser treatment in the treatment area within the last 6 months.
- Subjects must not have a personal history of malignant melanoma, keloid scars, generalized psoriasis or systemic diseases that would preclude the use of topical anesthesia.
- Subject must not have active sunburn or excessively tanned skin.
- Subjects must not be pregnant or breastfeeding, think they may be pregnant or are trying to get pregnant during the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Leah Dickerson contact
United States1 site, 1 recruiting
- Recruiting
Dermatology & Laser Surgery Center
Houston, Texas, 77030
About this study
Official title: Evaluation of the 2910 nm Erbium-Doped Fluoride Fiber Glass Laser for the Treatment of Advanced Perioral Lines and Wrinkles
The primary objective is to assess the efficacy, safety and satisfaction associated with the resurfacing treatment of perioral lines and wrinkles with the 2,910 nm mid-infrared Fiber Laser (UltraClear, Acclaro Medical) using both superficial epidermis ablation capabilities and the deep ablative and coagulative capabilities into the dermis for rejuvenation.
Participants will receive up to two treatments spaced 6-8 weeks apart, followed by a 1-month and 3-month follow-up visit during which the device will be evaluated for its effectiveness defined as improvement addressing perioral lines and wrinkles utilizing multiple scales completed by the investigator and blinded Independent Photographic Reviewers (IPRs). Additionally, safety, subjective overall aesthetic improvement and satisfaction will be monitored and tracked.
- Conditions
- Photodamaged Skin, Rhytids, Lines Skin, Wrinkles and Rhytides
- Being tested
- Laser Resurfacing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser ResurfacingDevice
Also called Ablative Fractional Laser Resurfacing, 2910 nm mid-infrared fiber laser
Enrolled participants will be treated with the UltraClear 2,910nm mid-infrared laser using both superficial epidermal ablation and deep ablative and coagulative capabilities in the dermis for rejuvenation with a specific focus on perioral lines and wrinkles.
| Study group | Role | What they receive |
|---|---|---|
| Part 2 Clinical Study Procedure | Experimental | UltraClear 2,910nm mid-infrared laser using both superficial epidermal ablation and deep ablative and coagulative capabilities in the dermis for rejuvenation addressing perioral lines and wrinkles. Receives: Device: Laser Resurfacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fitzpatrick Wrinkling and Degree of Elastosis Scale (FWS)
Changes in perioral lines and wrinkles utilizing the Fitzpatrick Wrinkling and Degree of Elastosis Scale (FWS).
A change of one point is considered a statistically significant change on a scale of 1-9, with one being the least noticeable wrinkles and nine being the deepest and most noticeable wrinkles.
1 - 3 Fine wrinkles 4 - 6 Fine to moderate depth wrinkles, moderate number of lines 7 - 9 Fine to deep wrinkles, numerous lines, with or without redundant skin folds
Measured: From enrollment to the final follow-up visit (3-months following final treatment)
Percentage of Treatment Responders
- Comparison of the proportion of subjects (i.e., percentage of treatment responders) correctly identified by at least two out of three blinded Independent Photographic Reviewers (IPR).
Measured: From enrollment to the final follow-up visit (3-months following final treatment)
Change in Physician Global Aesthetic Improvement Scale (PGAIS)
Defined as a change in perioral lines and wrinkles utilizing the Physician Global Aesthetic Improvement Scale (PGAIS).
The PGAIS is a five-point scale used by physicians to objectively rate the aesthetic outcome of a treatment by comparing a patient's pre-treatment and post-treatment appearance.
The scoring is numerical (1-5), with a score of 3, 4, or 5 points being considered significant.
- - Worse: The patient's aesthetic appearance has deteriorated compared to baseline
- - No Change: There is no noticeable difference from the pre-treatment state.
- - Improved: The physician notes a visible enhancement, but further treatment could still be beneficial
- - Much Improved: There is a marked, clear aesthetic improvement
- - Very Much Improved: An optimal cosmetic result has been achieved
Measured: From enrollment to the final follow-up visit (3-months following final treatment)
Secondary outcomes (1)
Subject Self-Reported Improvements
The SGAIS is a measure of aesthetic improvement relative to baseline, pre-treatment condition. A meaningful change on the Subject Global Aesthetic Improvement Scale (SGAIS) is defined as an improvement of at least one grade, indicating that the subject perceives a beneficial change in their appearance. The SGAIS is a patient-reported outcome measure (PROM) that is completed by the patient/subject to assess their own perception of aesthetic improvement following treatment.
The scale is reported with scores of 1-5.
- - Worse: The subject perceives a deterioration in their appearance compared to before treatment
- - No Change: There is no noticeable difference from the pre-treatment state
- - Improved: The subject notes a visible aesthetic improvement
- - Much Improved: The subject notes marked and definite aesthetic improvement
- - Very Much Improved: The subject believes an optimal comment result has been achieved
Measured: From enrollment to the final follow-up visit (3-months following final treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2025
- Study start1 Mar 2025
- Primary completionDec 2025 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Photodamaged SkinStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FA Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul Friedman, MD, Principal investigator, Director, Dermatology & Laser Surgery Center Clinical Assistant Professor of Dermatology, UT Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07222397
- Sponsor's protocol ID
- UC 26-2025
- Status last verified
- Oct 2025
- First submitted
- 21 Feb 2025
- Last updated
- 29 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the 2910 nm Erbium-Doped Fluoride Fiber Glass Laser for the Treatment of Advanced Perioral Lines and Wrinkles
- ClinicalTrials.gov ID
- NCT07222397
- Acronym / sponsor ID
- UC 26-2025
- Conditions
- Photodamaged Skin, Rhytids, Lines Skin, Wrinkles and Rhytides
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- FA CorporationIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 29 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.
The primary objective is to assess the efficacy, safety and satisfaction associated with the resurfacing treatment of perioral lines and wrinkles with the 2,910 nm mid-infrared Fiber Laser (UltraClear, Acclaro Medical) using both superficial epidermis ablation capabilities and the deep ablative and coagulative capabilities into the dermis for rejuvenation.
Participants will receive up to two treatments spaced 6-8 weeks apart, followed by a 1-month and 3-month follow-up visit during which the device will be evaluated for its effectiveness defined as improvement addressing perioral lines and wrinkles utilizing multiple scales completed by the investigator and blinded Independent Photographic Reviewers (IPRs). Additionally, safety, subjective overall aesthetic improvement and satisfaction will be monitored and tracked.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Part 2 Clinical Study Procedure | Experimental | Device: Laser ResurfacingUltraClear 2,910nm mid-infrared laser using both superficial epidermal ablation and deep ablative and coagulative capabilities in the dermis for rejuvenation addressing perioral lines and wrinkles. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Fitzpatrick skin type I-IV.
- Male or female.
- Subjects must be between 50 and 80 years of age.
- Subjects must have the ability to receive up to two full face resurfacing laser treatment with specific focus on advanced perioral lines and wrinkles.
- Subjects must read, understand, and sign the Informed Consent Form.
Key exclusion criteria (16 listed)
- Subjects must not have active localized or systemic infections.
- Subjects must not have a compromised ability for wound healing, such as: malnutrition, steroid use, history of collagen vascular disease (e.g., lupus, scleroderma, history of keloid scar formation), atrophic dermatitis or immunologic abnormalities such as vitiligo.
- Subjects must not have had treatments with 5FU, diclofenac, imiquimod, steroids, retinoids, or PDT within 1-month prior to enrollment.
- Subjects must not currently be taking Accutane or have taken Accutane within the last 1-month.
- Subjects must not have a known allergy to lidocaine or epinephrine, topical or injectable products containing lidocaine or any numbing medications.
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 |
|---|---|---|
| Laser ResurfacingAlso: Ablative Fractional Laser Resurfacing, 2910 nm mid-infrared fiber laserEnrolled participants will be treated with the UltraClear 2,910nm mid-infrared laser using both superficial epidermal ablation and deep ablative and coagulative capabilities in the dermis for rejuvenation with a specific focus on perioral lines and wrinkles. | Device | Part 2 Clinical Study Procedure |
Primary outcome
Change in Fitzpatrick Wrinkling and Degree of Elastosis Scale (FWS)
Time frame: From enrollment to the final follow-up visit (3-months following final treatment)
Changes in perioral lines and wrinkles utilizing the Fitzpatrick Wrinkling and Degree of Elastosis Scale (FWS). A change of one point is considered a statistically significant change on a scale of 1-9, with one being the least noticeable wrinkles and nine being the deepest and most noticeable wrinkles. 1 - 3 Fine wrinkles 4 - 6 Fine to moderate depth wrinkles, moderate number of lines 7 - 9 Fine to deep wrinkles, numerous lines, with or without redundant skin folds
Percentage of Treatment Responders
Time frame: From enrollment to the final follow-up visit (3-months following final treatment)
o Comparison of the proportion of subjects (i.e., percentage of treatment responders) correctly identified by at least two out of three blinded Independent Photographic Reviewers (IPR).
Change in Physician Global Aesthetic Improvement Scale (PGAIS)
Time frame: From enrollment to the final follow-up visit (3-months following final treatment)
Defined as a change in perioral lines and wrinkles utilizing the Physician Global Aesthetic Improvement Scale (PGAIS). The PGAIS is a five-point scale used by physicians to objectively rate the aesthetic outcome of a treatment by comparing a patient's pre-treatment and post-treatment appearance. The scoring is numerical (1-5), with a score of 3, 4, or 5 points being considered significant. 1. - Worse: The patient's aesthetic appearance has deteriorated compared to baseline 2. - No Change: There is no noticeable difference from the pre-treatment state. 3. - Improved: The physician notes a visible enhancement, but further treatment could still be beneficial 4. - Much Improved: There is a marked, clear aesthetic improvement 5. - Very Much Improved: An optimal cosmetic result has been achieved
1 secondary outcome
Subject Self-Reported Improvements
Time frame: From enrollment to the final follow-up visit (3-months following final treatment)
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 29 Oct 2025.
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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.
Leah Dickerson contact
Paul Friedman, MD principal investigator
Director, Dermatology & Laser Surgery Center Clinical Assistant Professor of Dermatology, UT Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser Resurfacing in people with Photodamaged Skin and Rhytids, run by FA Corporation at 1 site 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 10 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: looking for participants now, as of the sponsor's last update on 29 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact Mary Dick, MD (713-900-3900, drdick@dermlasersurgery.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fitzpatrick Wrinkling and Degree of Elastosis Scale (FWS) (time frame: From enrollment to the final follow-up visit (3-months following final treatment)). The study lists 3 primary outcomes in all. 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 29 Oct 2025.