Safety and Efficacy of 2910 nm Fiber Laser Resurfacing and Laser-Coring (NCT07254884) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Safety and Efficacy of 2910 nm Fiber Laser Resurfacing and Laser-Coring
40 participantsStarted 2025-11
Plain-language summary
The primary objective of this clinical trial is to evaluate the safety and effectiveness of the 2,910 nm mid-infrared erbium-doped fluoride fiber glass laser (UltraClear, Acclaro Medical) for non-invasive dermatological aesthetic treatment of three facial regions: eyebrow lift (Region 1), submental tissue lift (Region 2), and improvement of rhytids and skin laxity in the cheeks, midface, and jawline (Region 3).
Who can participate
Age range
45 Years – 85 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 type I-VI
* Male or female
* Subjects must be between 45 and 85 years of age
* Subjects must have the ability to receive two and up to three full face and upper neck resurfacing laser treatments (pending PI discretion) with desire to lift facial lax skin, submental and/or to lift the eyebrow area and/or improve facial wrinkles appearance
* Subjects must read, understand, and sign the Informed Consent Form
* Subjects must be willing and able to comply with all follow-up visit requirements
* 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 (2) Moderate Sagging to (4) Very Severe Sagging based on the Merz Scale: Jawline at Rest
* 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
Exclusion Criteria:
* 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), atopic dermatitis or immunologic abnormalities such as vitiligo
* Subjects must not be current smoker or have significant histor…
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
Objective measurement of maximal eyebrow lift according to quantitative 2D imaging.
Timeframe: Six months following final treatment
2
Blinded Photographic Review
Timeframe: Six months following final treatment
3
○ Objective measurement of lax submental tissue lift according to quantitative 2D imaging.