Tolerability of Using a Post-Treatment Topical Adjuvant Combination Following Fractional Radiofrequency Ablation
2020年10月15日 更新者：Venus Concept
Clinical Evaluation of the Tolerability of Using a Post Treatment Topical Adjuvant Combination Following Fractional Radiofrequency Ablation Using the Venus Viva
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
49
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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California
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Newport Beach、California、美国、92660
- Dr. George Taylor
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
21年 至 75年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Topical combination therapy
Application of human bone marrow stem cell derived growth factor and cytokines serum followed by a botanical lipid-based occlusive immediately post-radio-frequency treatment of the face
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其他名称：
|
|
无干预：Standard of care
No topical therapies for 24 hours post-radio-frequency treatment of the face
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Subject Treatment Tolerability Score Post Treatment 1 at 24hrs Post Treatment
大体时间：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.
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24hr post treatment one
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Subject Treatment Tolerability Score Post Treatment 1 at 72hrs Post Treatment
大体时间：72 hrs post treatment one
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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.
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72 hrs post treatment one
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Subject Treatment Tolerability Score Post Treatment 2 at 24hrs Post Treatment
大体时间：24hr post treatment two
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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.
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24hr post treatment two
|
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Subject Treatment Tolerability Score Post Treatment 2 at 72 Hrs Post Treatment
大体时间：72hr post treatment two
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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.
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72hr post treatment two
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Visual Analog Scale
大体时间：immediately following radio-frequency treatment
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10 cm Subject discomfort scale where 10 cm indicates 'Pain as bad as it can be' and 0 cm indicates there is no pain at all associated with the application of the treatment.
Zero pain means a better outcome.
Subjects were categorized as to having no pain (0 - 0.4cm), mild pain (0.5 - 4.4cm), moderate pain (4.5 - 7.4cm) and severe pain (7.5 - 10cm).
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immediately following radio-frequency treatment
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Fitzpatrick Wrinkle and Elastosis Scale
大体时间：change in appearance of wrinkles from baseline and at end of study, average of 24 days
|
Investigator assessment of improvement in wrinkles and elastosis where Class I indicates fine wrinkles, Class II indicates fine to moderate depth wrinkles with a moderate number of lines and Class III indicates fine to deep wrinkles, numerous lines with or without redundant skin folds with a score of 1 - 3 (Mild) indicates fine texture changes with subtly accentuated skin lines, a score of 4 - 6 (Moderate) indicates distinct papular elastosis ([indvidual papules with yellow translucency under direct lighting] and dyschromia and a score of 7 - 9 (Severe) indicates multipapular and confluent elastosis [thickened yellow and pallid] approaching or consistent with cutis rhomboidalis.
A lower class and a lower score means a better outcome.
Subjects were divided into 3 categories - No change in FWES score, change in FWES score by one and non-evaluable.
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change in appearance of wrinkles from baseline and at end of study, average of 24 days
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Global Aesthetic Improvement Scale
大体时间：change in skin appearance between baseline and at end of study, average of 24 days
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Investigator assessment of aesthetic improvement where 1 shows exceptional improvement, 2 shows very improved, 3 shows improvement, 4 shows unchanged and 5 indicates that the subject appearance has worsened.
A low score means a better outome.
Subjects were categorized to either GAIS improved or GAIS no change.
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change in skin appearance between baseline and at end of study, average of 24 days
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Joseph L Reiz, BSc、Venus Concept Ltd.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2016年8月1日
初级完成 (实际的)
2016年12月1日
研究完成 (实际的)
2017年2月27日
研究注册日期
首次提交
2016年8月31日
首先提交符合 QC 标准的
2016年9月6日
首次发布 (估计)
2016年9月12日
研究记录更新
最后更新发布 (实际的)
2020年11月3日
上次提交的符合 QC 标准的更新
2020年10月15日
最后验证
2020年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.