Prospective, Multi-center, Pivotal Trial Evaluating the Safety and Effectiveness of the Ulthera® System for Improvement in Lines and Wrinkles of the Décolletage
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ulthera, Inc
- 入组人数
- 129
- 试验地点
- 4
- 主要终点
- Percentage of Participants With a Reduction in Chest Wrinkles at 90 Days Post Treatment
研究概览
简要总结
This is prospective, multi-center clinical trial. Enrolled subjects will receive one Ulthera® treatment on the decolletage. Follow-up visits will occur at 90 and 180 days following treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female, aged 35 to 70 years.
- •Subject in good health.
- •Moderate to severe skin lines and wrinkles on the décolletage; grade of ≥4 on a chest wrinkle scale.
- •Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.
- •Willingness and ability to comply with protocol requirements.
- •Subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating.
- •Absence of physical conditions unacceptable to the investigator.
- •Willingness and ability to provide written consent for study-required photography.
- •Willingness and ability to provide written informed consent.
排除标准
- •Presence of an active systemic or local skin disease that may affect wound healing.
- •Scarring in areas to be treated.
- •Tattoos in the areas to be treated.
- •Patients with ports or defibrillators.
- •Any open wounds or lesions in the area.
- •Active and severe inflammatory acne in the region to be treated.
- •Patients who have a history with keloid formation or hypertrophic scarring.
- •Inability to understand the protocol or to give informed consent.
- •Retinoid, microdermabrasion, or prescription level glycolic acid treatments to the décolletage area within two weeks prior to study participation or during the study.
- •Marked décolletage asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin.
- •History of chronic drug or alcohol abuse.
- •History of autoimmune disease.
- •Concurrent therapy that would interfere with the evaluation of the safety or effectiveness of the study device.
- •Subjects who anticipate the need for surgery or overnight hospitalization during the study.
- •Subjects who have a history of poor cooperation, noncompliance with medical treatment, or unreliability.
- •Concurrent enrollment in any study involving the use of investigational devices or drugs.
- •Current smoker or history of smoking in the last one year.
- •History of using the following prescription medications:
- •Topical Retinoids to the area within the past two weeks;
- •Antiplatelet agents/anticoagulants (Coumadin, Heparin, Plavix).
- •Psychiatric drugs that would impair the subject from understanding the protocol requirements or understanding and signing the informed consent.
研究组 & 干预措施
Ulthera System Treatment
A single triple-depth Ulthera System treatment of the decolletage delivering treatment at 4.5mm, 3.0mm and 1.5mm depths.
干预措施: Ulthera System Treatment (Device)
结局指标
主要结局
Percentage of Participants With a Reduction in Chest Wrinkles at 90 Days Post Treatment
时间窗: 90 Days post-treatment
Assessment of improvement, in a blinded fashion, using a Chest Wrinkle Scale at 90 days post-treatment. However, during conduct of the trial, the Chest Wrinkle scale was deemed inadequate as a primary endpoint in this study. Therefore, conduct of a traditional blinded masked assessment, the gold-standard measure in aesthetics, was used as the primary endpoint,i.e., improvement in wrinkles and lines of the décolletage as determined by a blinded, masked, qualitative assessment of photographs at 90 days post-treatment compared to baseline. "Improvement" = a blinded evaluator assessed an "Improvement" when evaluating a masked, paired photo set and correctly chose the Post treatment photo. "Incorrect" = a blinded evaluator assessed an "Improvement" when evaluating a masked, paired photo set but incorrectly chose the Post treatment photo.
Percentage of Participants With a Reduction in Chest Wrinkles at 180 Days Post Treatment
时间窗: 180 days post treatment
Assessment of improvement, in a blinded fashion, using a Chest Wrinkle Scale at 180 days post-treatment. However, during conduct of the trial, the Chest Wrinkle scale was deemed inadequate as a primary endpoint in this study. Therefore, conduct of a traditional blinded masked assessment, the gold-standard measure in aesthetics, was used as the primary endpoint, improvement in wrinkles and lines of the décolletage as determined by a blinded, masked, qualitative assessment of photographs at 180 days .post-treatment compared to baseline. "Improvement" = a blinded evaluator assessed an "Improvement" when evaluating a masked, paired photo set and correctly chose the Post treatment photo. "Incorrect" = a blinded evaluator assessed an "Improvement" when evaluating a masked, paired photo set but incorrectly chose the Post treatment photo.
次要结局
- Overall Aesthetic Improvement at 180 Days Post-treatment(180 days post-treatment)
- Subject Satisfaction at 180 Days Post-treatment(180 days post-treatment)
- Subject Satisfaction at 90 Days Post-treatment(90 days post-treatment)
- Overall Aesthetic Improvement at 90 Days Post-treatment(90 days post-treatment)