2910 nm Erbium-Doped Fluoride Fiber Glass Laser for the Treatment of Advanced Perioral Lines and Wrinkles

Официальное название

Evaluation of the 2910 nm Erbium-Doped Fluoride Fiber Glass Laser for the Treatment of Advanced Perioral Lines and Wrinkles

Обзор

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.

Вмешательства

• Устройство Laser Resurfacing
  Enrolled participants will be treated with the UltraClear 2,910nm mid-infrared laser using both superficial epidermal ablation and deep ablative and coagulative capabilities in the dermis for rejuvenation with a specific focus on perioral lines and wrinkles.

Первичные конечные точки

• Change in Fitzpatrick Wrinkling and Degree of Elastosis Scale (FWS) [Срок оценки: From enrollment to the final follow-up visit (3-months following final treatment)]
• Percentage of Treatment Responders [Срок оценки: From enrollment to the final follow-up visit (3-months following final treatment)]
• Change in Physician Global Aesthetic Improvement Scale (PGAIS) [Срок оценки: From enrollment to the final follow-up visit (3-months following final treatment)]

Вторичные конечные точки (1)

• Subject Self-Reported Improvements [Срок оценки: From enrollment to the final follow-up visit (3-months following final treatment)]

Критерии участия

Критерии включения

• 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).
• 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.

Критерии исключения

• 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), 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.
• Subject must not have had permanent filler i.e., Polymethylmethacrylate (PMMA) in the treatment area.
• Subjects must not have had neurotoxins within the last 3-months in the treatment area.
• Subject must not have a personal history of any facial threads i.e., PDO (Polydioxanone), PLLA (Polylactic acid), PCL (Polycaprolactone) in the treatment area within the last 12 months.
• Subject must not have had a pulse dye or vascular laser, non-ablative laser, microneedling, or energy-based device treatment in the treatment area within the last 3 months.
• Subject must not have had an ablative laser treatment in the treatment area within the last 6 months.
• Subjects must not have a personal history of malignant melanoma, keloid scars, generalized psoriasis or systemic diseases that would preclude the use of topical anesthesia.
• Subject must not have active sunburn or excessively tanned skin.
• Subjects must not be pregnant or breastfeeding, think they may be pregnant or are trying to get pregnant during the study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Dermatology & Laser Surgery Center — Houston

Идентификаторы

NCT: NCT07222397 · UC 26-2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗