NCT06726122Enrolling By Invitation不适用
Clinical Study to Evaluate the Efficacy and Safety of Matrix Pro Treatment for Facial, Submental and Neck Laxity
适应症
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 60
- 试验地点
- 6
- 主要终点
- Evaluation of change in facial, submentum, and neck laxity
研究概览
简要总结
This is a non-randomized, multi-center, open-label, prospective clinical trial evaluating clinical treatments with the Matrix Pro Applicator for the improvement of facial and/or submental and neck laxity.
详细描述
Eligible participants will receive up to three treatments with the Matrix Pro Applicator of the Profound Matrix System to address facial and neck laxity. Treatments will be approximately 6 weeks apart (± 2 weeks). All participants will undergo follow-up evaluations at 1 month (4 weeks ± 2 weeks) and 3 months (13 weeks ± 2 weeks) after the final treatment. Additional follow-up visits may be required per Sponsor and PI discretion
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
- 18 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy female and male subjects between 18 to 84 years of age with Fitzpatrick Skin Type I - VI.
- •Willing to receive Profound Matrix treatments with Matrix Pro applicator
- •Able and willing to comply with the treatment/follow-up schedule and comply with all study (protocol) requirements.
- •Willing to provide signed, informed consent to participate in the study
- •Willing to have photographs and images taken of the treated areas to be used in evaluations, publications, presentations, and marketing materials (Subject identity will be masked).
排除标准
- •Any of the following will exclude the subject from the study:
- •Pregnant or planning to become pregnant, having given birth less than 3 months prior to enrollment into the study, and/or breast feeding
- •Pacemaker or internal defibrillator or any active electrical implant anywhere in the body
- •Superficial metal or other implants in the treatment area, except superficial dental implants, unless the implants can be removed or covered with rolled gauze during treatment
- •Skin cancer in the treatment area or history of melanoma
- •History of current cancer and/or subject has undergone chemotherapy within the last 12 months
- •Severe concurrent conditions, such as cardiac disorders
- •Impaired immune system or use of immunosuppressive medications, except for topical products and inhaler medications per investigator discretion
- •Herpes Simplex Virus (HSV) in the intended treatment area unless treated following a prophylactic regimen
- •Poorly controlled endocrine disorders such as poorly controlled diabetes
- •Active skin condition in the treatment area such as skin infection, sores, psoriasis, eczema, rash, or open wounds
- •History of abnormal wound healing, keloid, or hypertrophic scar formation, as well as very thin or fragile skin
- •History of collagen vascular disease or vasculitic disorders
- •Known allergy to medication to be used during treatments such as allergy to topical anesthetic (e.g., lidocaine)
- •History of systemic corticosteroid therapy in past six months
- •Tattoos or permanent makeup in the intended treatment area
- •Excessively tanned skin
- •Facelift in the last 12 months
- •Aesthetics treatments/procedures (e.g., facial resurfacing and deep chemical peeling) within the last 4 months within the intended treatment area
- •Neuromodulator injections (e.g., Botox®), collagen, non-permanent dermal filler, fat injections or other methods of augmentation with injected biomaterial in the intended treatment area within the last 3 months
- •Permanent synthetic fillers (e.g., silicone) in the intended treatment area
- •Absorbable facial threads within the last 12 months or non-absorbable facial threads within the intended treatment area
- •In the opinion of the Investigator, the subject is unwilling or unable to adhere to the study requirements or is otherwise unsuitable for study participation
结局指标
主要结局
Evaluation of change in facial, submentum, and neck laxity
时间窗: From subject enrollment to completion of 3-month follow-up visit, up to 32 weeks.
Evaluation of change in facial, submentum, and neck laxity based on correct identification of subject's post-treatment photograph by at least 2 of the 3 independent blinded reviewers.
次要结局
未报告次要终点
研究者
研究点 (6)
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