Feasibility Study: Evaluation of the Efficacy of a Liposome-encapsulated Lidocaine Topical Anesthetic for Reducing Discomfort Associated With Ultherapy™ Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ulthera, Inc
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Treatment-related pain
研究概览
简要总结
This study will evaluate the efficacy of a lidocaine topical anesthetic (numbing cream) for reducing discomfort associated with Ultherapy™ treatment.
详细描述
All subjects will receive a full face and neck Ultherapy™ treatment. Thirty (30) minutes prior to treatment, a topical anesthetic (numbing cream) will be applied to one side of the face and neck and a placebo cream with similar consistency and color will be applied to the other side of the face and neck, in a randomized fashion. The subject and investigator or sub-investigator performing Ultherapy™ treatment will be blinded to the side to which the topical anesthetic is applied. Pain scores will be collected following treatment of each section of the face and neck on both sides. Subjects will return for a 90-day post-treatment visit to assess improvement in skin laxity, and overall lifting and tightening of skin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, aged 30 to 65 years.
- •Chosen an Ultherapy™ treatment as part of their treatment regimen.
- •Subject in good health.
- •Skin laxity on the face and neck.
- •Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the followup period.
- •Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study
排除标准
- •Known sensitivity to lidocaine or any other anesthetic of the amide type.
- •History of anaphylactic shock.
- •Presence of an active systemic or local skin disease that may affect wound healing.
- •Current therapy with class I antiarrhythmic drugs (e.g., tocainide, mexiletine).
- •Known or suspected hypersensitivity to LMX-4 active substance, or any of the amide-type local anaesthetics, or any of the excipients (protocol section 10.3).
- •Severe solar elastosis.
- •Excessive subcutaneous fat in the face and neck.
- •Body mass index of 30 or greater.
- •Excessive skin laxity on the face and neck.
- •Significant scarring in areas to be treated.
- •Significant open facial wounds or lesions.
- •Severe or cystic acne on the face.
- •Presence of a metal stent or implant in the facial area to be treated.
研究组 & 干预措施
Topical anesthetic - L.M.X.4.® cream
Topical anesthetic cream, L.M.X.4.® cream, applied to one side of the face and neck prior to Ulthera System treatment.
干预措施: L.M.X.4.® cream (Drug)
Topical anesthetic - L.M.X.4.® cream
Topical anesthetic cream, L.M.X.4.® cream, applied to one side of the face and neck prior to Ulthera System treatment.
干预措施: Ulthera System Treatment (Device)
Placebo cream
A placebo cream with similar consistency and color will be applied to the other side of the face and neck prior to Ulthera System treatment.
干预措施: A placebo cream (Other)
Placebo cream
A placebo cream with similar consistency and color will be applied to the other side of the face and neck prior to Ulthera System treatment.
干预措施: Ulthera System Treatment (Device)
结局指标
主要结局
Treatment-related pain
时间窗: During treatment
The validated 10-point pain NRS scale will be used to measure average pain scores reported by subject immediately after each facial region is treated.
次要结局
- Improvement in skin laxity.(90 days post-treatment)