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
Qualifiers
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
Treatments tested in this trial
- 2,910 nm mid-infrared erbium-doped fluoride fiber glass laser (UltraClear, Acclaro Medical)
Treatment groups
40 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov