Safety and Efficacy of 2910 nm Fiber Laser Resurfacing and Laser-Coring
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-85
SponsorFA Corporation
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 history of smoking
Subjects must not have had treatments with systemic steroids or systemic retinoids in the 4-months prior to enrollment
Trial design
Design model
Single group
Treatments tested in this trial
2,910 nm mid-infrared erbium-doped fluoride fiber glass laser (UltraClear, Acclaro Medical)
DeviceEnrolled subjects will receive a series of two with an optional third 2,910 nm Fiber Laser treatments using fractional ablative resurfacing modes, laser-coring and full ablation addressing the full face and upper neck.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Laser Treatment ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Objective measurement of maximal eyebrow lift according to quantitative 2D imaging.
Time frame
Six months following final treatment2
Blinded Photographic Review
Blinded independent photographic review correct identification of pre-post image sequence for eyebrow lift, submental lift and improvement of lax skin in the lower face and submentum.
Time frame
Six months following final treatment3
○ Objective measurement of lax submental tissue lift according to quantitative 2D imaging.
Time frame
Six months following final treatmentSecondary outcomes
1
Physician rating on the Global Aesthetic Improvement Scale (PGAIS)
Physician graded aesthetic improvement, scored from photographs. Scale 0 - 4 with 4 being the most improved and 0 being worse than the original condition. 4 - Very much improved, optimal cosmetic result, very significant improvement 3 - Much improved, market improvement in appearance from the initial condition, but not completely optimal, marked 2 - Improved, obvious improvement in appearance from the initial condition, but a pretreatment is needed, moderate 1 - No change, the appearance is essential the same as the original condition in appearance from he initial condition 0 - Worse, the appearance is worse than the original condition, no improvement
Time frame
Six months following final treatment2
Subjects rating on the Subject Global Aesthetic Improvement Scale & Satisfaction Questionnaire (SGAIS)
Subjects rate their perceived improvement of the treatment area on a 5 point scale. 4- Very Much Improved, optimal cosmetic result, very significant improvement 3 - Much Improved, marked improvement in appearance from he initial condition but not completely optimal, marked 2 - Improved, obvious improvement in appearance from the initial condition, but a re-treatment is needed, moderate 1 - No change, the appearance is essentially the same as the original condition in appearance from the initial condition 0 - Worse, the appearance is worse than the original condition, no improvement
Time frame
Six months following final treatmentOther outcomes
1
Evaluation of the pain and discomfort after treatment as reported by the subject on a visual analog scale (VAS)
VAS is a 10 point scale, reported by the subject. Subjects will be asked to report on a scale of 0-10, the average level of discomfort experienced during treatment. 0 - No Pain 5 - Moderate Pain 10 - Unbearable Pain
Time frame
Periprocedural and 15 minutes post-procedureLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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