Clinical Evaluation of the Tolerability of Using a Post Treatment Topical Adjuvant Combination Following Fractional Radiofrequency Ablation Using the Venus Viva
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Subject Treatment Tolerability Score Post Treatment 1 at 72hrs Post Treatment
研究概览
简要总结
The purpose of this study is to compare the tolerability of the application of a combination of a serum containing human bone marrow stem cell derived growth factor (SCR Complex) and cytokines and a botanical lipid-based occlusive (Bio Cel) immediately following fractional radiofrequency treatment using the Venus Viva versus standard of care.
详细描述
Randomized, open-label, multi-centre study to evaluate the tolerability of the application of a combination of a serum containing human bone marrow stem cell derived growth factor and cytokines (SCR Complex™) and a botanical lipid based occlusive (Bio Cel™) following facial fractional RF treatments using the Venus Viva™ SR system. Each subject will receive 2 treatments separated by a 3-week interval. Subjects will complete a VAS and Tolerability Scale immediately following each treatment. Telephone follow-up calls by the site will ask the subject to respond to the Self-Report Adverse Event Questionnaire 24 and 72 hours after the first treatment and 24 hours after the second treatment. Subjects will complete a Home Tolerability Scale 24 and 72 hours after the first treatment and 24 hours after the second treatment. Subjects will return for the final FU visit and be asked to respond to the Self-Report Adverse Event Questionnaire and complete the Home Tolerability Scale for 72 hours. The investigator will also evaluate the subject's improvement using the GAIS at this visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Undergoing a dermatological procedure requiring ablation and resurfacing of the facial skin utilizing the Venus Viva™ SR system.
- •Women of child-bearing age are required to be using a reliable method of birth control prior to enrollment and throughout their participation in the study.
- •Able to tolerate the treatment as determined by a test spot application(s).
排除标准
- •Superficial metal or other implants in the treatment area
- •Tattoos, permanent makeup, scars or piercings in the treatment area.
- •Any active condition in the treatment area, such as sores, psoriasis, eczema and rash.
- •Any surgical procedure in the treatment area within the last three months or before complete healing.
- •Receiving therapies or medication that may interfere with the study treatment.
结局指标
主要结局
Subject Treatment Tolerability Score Post Treatment 1 at 72hrs Post Treatment
时间窗: 72 hrs post treatment one
Tolerability 5-point Likert scale where 4 - Very Tolerable, 3 - Tolerable, 2 - Having no opinion, 1 - Intolerable and 0 - very intolerable; The higher the score, the more tolerable the subject indicates the treatment is.
Subject Treatment Tolerability Score Post Treatment 1 at 24hrs Post Treatment
时间窗: 24hr post treatment one
Tolerability 5-point Likert scale where 4 - Very Tolerable, 3 - Tolerable, 2 - Having no opinion, 1 - Intolerable and 0 - very intolerable; The higher the score, the more tolerable the subject indicates the treatment is.
Subject Treatment Tolerability Score Post Treatment 2 at 24hrs Post Treatment
时间窗: 24hr post treatment two
Tolerability 5-point Likert scale where 4 - Very Tolerable, 3 - Tolerable, 2 - Having no opinion, 1 - Intolerable and 0 - very intolerable; The higher the score, the more tolerable the subject indicates the treatment is.
Subject Treatment Tolerability Score Post Treatment 2 at 72 Hrs Post Treatment
时间窗: 72hr post treatment two
Tolerability 5-point Likert scale where 4 - Very Tolerable, 3 - Tolerable, 2 - Having no opinion, 1 - Intolerable and 0 - very intolerable; The higher the score, the more tolerable the subject indicates the treatment is.
次要结局
- Global Aesthetic Improvement Scale(change in skin appearance between baseline and at end of study, average of 24 days)
- Fitzpatrick Wrinkle and Elastosis Scale(change in appearance of wrinkles from baseline and at end of study, average of 24 days)
- Visual Analog Scale(immediately following radio-frequency treatment)