2910 nm Erbium-Doped Fluoride Fiber Glass Laser for the Treatment of Advanced Perioral Lines and … (NCT07222397) | Clinical Trial Compass
RecruitingNot Applicable
2910 nm Erbium-Doped Fluoride Fiber Glass Laser for the Treatment of Advanced Perioral Lines and Wrinkles
United States20 participantsStarted 2025-03-01
Plain-language 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 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.
Who can participate
Age range50 Years – 80 Years
SexALL
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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-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.
✓. 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).
Exclusion criteria
✕. Subjects must not have active localized or systemic infections.
What they're measuring
1
Change in Fitzpatrick Wrinkling and Degree of Elastosis Scale (FWS)
Timeframe: From enrollment to the final follow-up visit (3-months following final treatment)
2
Percentage of Treatment Responders
Timeframe: From enrollment to the final follow-up visit (3-months following final treatment)
3
Change in Physician Global Aesthetic Improvement Scale (PGAIS)
Timeframe: From enrollment to the final follow-up visit (3-months following final treatment)
. 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.
✕. 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.