NCT07759817尚未招募不适用
Safety and Efficacy of a 2,910 nm Fractional Ablative Fiber Laser (UltraClear®) for Improvements of Skin Laxity and Lifting of the Lower Face, Submental, and Neck Treatment Areas
FA Corporation2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2026年8月7日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Quantitative 2D Photographic Analysis:
研究概览
简要总结
This study evaluates the safety and effectiveness of the UltraClear® 2,910 nm fractional ablative fiber laser for improving skin laxity and tissue lifting in the lower face, submental, and neck areas. Up to 50 adults ages 35-65 will receive two laser treatments approximately 7 weeks apart at two clinical sites. Outcomes will be assessed approximately 90 days after the second treatment using photographic analysis and investigator- and participant-reported improvement scales.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Fitzpatrick skin types I-III participants with Fitzpatrick Skin Types IV-VI may be enrolled only at the investigator's discretion, based on individualized risk assessment documenting skin tone-related risk of post-inflammatory hyperpigmentation, wound healing history, and prior response to ablative or energy-based treatments. Risk assessment documentation must be retained in the participant's study file. Male or female.
- •Participants must be between 35 and 65 years of age.
- •Participants must have the ability to receive two lower face and full neck resurfacing laser treatments with desire for improvement in lifting and skin laxity.
- •Participants must read, understand, and sign the Informed Consent Form.
- •Participants must be willing and able to comply with all follow-up visit requirements.
- •Participants must agree to refrain from using cosmeceutical agents or topical agents during the study, except as directed by study investigator.
- •Participants must be rated as (2) Moderate Sagging to (4) Very Severe Sagging based on the Merz Jawline Grading Scale (MJGS)[11].
- •Participants must be rated as a (C) Grade 3: moderate laxity, (D) Grade 4: moderate to severe laxity or (E) Grade 5: severe laxity of the tissues of the neck based on the 5-Grade IBSA Neck Laxity Scale [12]
- •Participants of childbearing potential must 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.
- •Participants agree to maintain stable body weight, defined as no planned weight-loss program and no significant change in body weight (±10 lbs or ±5%) within 3 months prior to enrollment and throughout study participation.
- •Participants identified as an appropriate candidate for study treatment based on principal investigator's opinion.
排除标准
- •Participants must not have active localized or systemic infections.
- •Participants 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.
- •Participants must not be current smoker or have history of regular tobacco or nicotine use within 12 months prior to enrollment.
- •Participants must not have had treatments with systemic steroids or systemic retinoids in the 4-months prior to enrollment.
- •Participants must not have had treatments with 5FU, diclofenac, imiquimod or PDT within 1-month prior to enrollment.
- •Participants must not have severe or cystic facial acne; currently taking Accutane or have taken Accutane within the last 1-month.
- •Participants must not have a known allergy to lidocaine or epinephrine, topical or injectable products containing lidocaine or any numbing medications.
- •Participants must not have had previous surgery and/or fat transfer in the treatment area within the last 6-months.
- •Participant must not have had injectable soft tissue fillers within the last 12-months in the treatment area.
- •Participant must not have had Poly-L-Lactic acid (PLLA) or Calcium Hydroxylapatite (CaHA) fillers within the last 2 years in the treatment area.
- •Participant must not have had permanent filler i.e., Polymethylmethacrylate (PMMA) in the treatment area.
- •Participants must not have had neurotoxins within the last 4-months in the treatment area.
- •Participant 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.
- •Participant must not have had a pulse dye or vascular laser, non-ablative laser, microneedling or RF microneedling treatments in the treatment area within the last 3-months.
- •Participant must not have had an ultrasound treatment such as HIFU, monopolar RF energy-based devices, ablative laser treatments in the treatment area within the last 6-months.
- •Participants must not have a personal history of malignant melanoma, keloid scars, generalized psoriasis or systemic diseases that would preclude the use of topical anesthesia.
- •Participant must not have active sunburn or excessively tanned skin.
- •Participants must not be pregnant or planning to become pregnant, have given birth less than 3-months ago, and/or breastfeeding during the study. Participants of childbearing potential will be asked to confirm they are not pregnant at screening, at each treatment visit and at Visit 6: Day 139 ± 7 days (3-month follow-up) representing approximately 90 days following the second treatment and Visit 7: Day 229 ± 7 days (6-month follow-up).
研究组 & 干预措施
2910 nm fiber laser treatment
Experimental
Participants receive two treatments with the UltraClear® 2,910 nm fractional ablative fiber laser to the lower face, submental region, and neck, spaced approximately 7 weeks (±7 days) apart.
干预措施: 2910 nm fiber laser (UltraClear®) (Device)
结局指标
主要结局
Quantitative 2D Photographic Analysis:
时间窗: Visit 6 (Day 139 ± 7; approximately 90 days following the second treatment)
Proportion of participants achieving a ≥20 mm² reduction in submental area post treatment, measured by a blinded independent analyst using a five-point landmark methodology applied to standardized 2D photographs. The study-level responder rate must achieve statistical significance (p \< 0.05).
Blinded Photographic Review
时间窗: Assessed at Visit 6 (Day 139 ± 7; approximately 90 days following the second treatment)
Proportion of participants for whom ≥2 of 3 Blinded Independent Photographic Reviewers (BIPRs) correctly identify post-treatment improvement from paired baseline and Visit 6 photographs of the submental and neck regions. Pre-specified responder threshold: ≥80% of evaluable participants.
次要结局
- Investigator Global Aesthetic Improvement Scale (iGAIS)(Assessed at Visit 6 (Day 139 ± 7; approximately 90 days following the second treatment).)
- Investigator Merz Jawline Grading Scale (MJGS)(Assessed at Visit 6 (Day 139 ± 7; approximately 90 days following the second treatment).)
- Participant Global Aesthetic Improvement Scale (sGAIS)(Assessed at Visit 6 (Day 139 ± 7; approximately 90 days following the second treatment))
- FACE-Q™ Satisfaction with Lower Face and Jawline (Rasch-transformed score)(Assessed at Visit 6 (Day 139 ± 7; approximately 90 days following the second treatment))
- Participant satisfaction questionnaire(Assessed at Visit 6 (Day 139 ± 7; approximately 90 days following the second treatment))
研究者
研究点 (2)
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