Safety and Efficacy of a 2,910 nm Fractional Ablative Fiber Laser (UltraClear®) for Improvements … (NCT07759817) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Safety and Efficacy of a 2,910 nm Fractional Ablative Fiber Laser (UltraClear®) for Improvements of Skin Laxity and Lifting of the Lower Face, Submental, and Neck Treatment Areas
United States50 participantsStarted 2026-08-07
Plain-language summary
This study evaluates the safety and effectiveness of the UltraClear® 2,910 nm fractional ablative fiber laser for improving skin laxity and tissue lifting in the lower face, submental, and neck areas. Up to 50 adults ages 35-65 will receive two laser treatments approximately 7 weeks apart at two clinical sites. Outcomes will be assessed approximately 90 days after the second treatment using photographic analysis and investigator- and participant-reported improvement scales.
Who can participate
Age range
35 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Fitzpatrick skin types I-III participants with Fitzpatrick Skin Types IV-VI may be enrolled only at the investigator's discretion, based on individualized risk assessment documenting skin tone-related risk of post-inflammatory hyperpigmentation, wound healing history, and prior response to ablative or energy-based treatments. Risk assessment documentation must be retained in the participant's study file. Male or female.
. Participants must be between 35 and 65 years of age.
. Participants must have the ability to receive two lower face and full neck resurfacing laser treatments with desire for improvement in lifting and skin laxity.
. Participants must read, understand, and sign the Informed Consent Form.
. Participants must be willing and able to comply with all follow-up visit requirements.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Quantitative 2D Photographic Analysis:
Timeframe: Visit 6 (Day 139 ± 7; approximately 90 days following the second treatment)
2
Blinded Photographic Review
Timeframe: Assessed at Visit 6 (Day 139 ± 7; approximately 90 days following the second treatment)
. Participants must agree to refrain from using cosmeceutical agents or topical agents during the study, except as directed by study investigator.
. Participants must be rated as (2) Moderate Sagging to (4) Very Severe Sagging based on the Merz Jawline Grading Scale (MJGS)\[11\].
. Participants must be rated as a (C) Grade 3: moderate laxity, (D) Grade 4: moderate to severe laxity or (E) Grade 5: severe laxity of the tissues of the neck based on the 5-Grade IBSA Neck Laxity Scale \[12\]
Exclusion criteria
. Participants must not have active localized or systemic infections.
. Participants 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), atopic dermatitis or immunologic abnormalities such as vitiligo.
. Participants must not be current smoker or have history of regular tobacco or nicotine use within 12 months prior to enrollment.
. Participants must not have had treatments with systemic steroids or systemic retinoids in the 4-months prior to enrollment.
. Participants must not have had treatments with 5FU, diclofenac, imiquimod or PDT within 1-month prior to enrollment.
. Participants must not have severe or cystic facial acne; currently taking Accutane or have taken Accutane within the last 1-month.
. Participants must not have a known allergy to lidocaine or epinephrine, topical or injectable products containing lidocaine or any numbing medications.
. Participants must not have had previous surgery and/or fat transfer in the treatment area within the last 6-months.