Follow Up Study: The Effect Of Hair2Go Maintenance Treatments on Long Term Hair Removal
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 6
- 主要终点
- Hair clearance at final follow up
研究概览
简要总结
The current study is a follow up study designed to gather information about the effect of the number of Hair2Go maintenance treatments on hair clearance 1 year after the last basic Hair2Go treatment. This study includes taking photos and documenting endpoints but does not include treatments.
详细描述
The Hair2Go device is intended for short-term and long-term removal of unwanted hair adjunctive to shaving. The device uses a technology called Elōs, which is a combination of electrical field at radio frequencies (RF) and intense optical energy, that are simultaneously applied to the tissue and were found to have synergistic effects. Thus, lower levels of both energies are used to facilitate the treatment for individuals of all skin types and hair colors.
This study is a multicenter study. Subjects that completed the basic treatments of previous Hair2Go studies (OHR-2, OHR-3, or OHR-5-Face) will be offered the option to enroll in this study that will not include treatments. The individual data collected in the OHR-2 (and its extensions, i.e. OHR2-P and OHR2-1Y), OHR-3, and OHR-5-Face studies will be used for the analysis together with data gathered in this study. Photographs of the previously treated areas will be taken 3, 6, 9, and 12 months after the last basic treatment if they were not already taken as part of the OHR-2, one of its extensions (i.e. OHR2-P and OHR2-1Y), or OHR-5-Face.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Completed the basic treatments of OHR-2, OHR-3, or OHR-5-Face studies.
- •Healthy males and females, between 18 and 65 years of age.
- •Willing to sign informed consent.
- •Willing to follow the protocol schedule.
- •Willingness to have photographs of the treated area taken that may be used for marketing and educational presentation and/or publications
- •Willingness to avoid shaving 1 week prior to the visits.
排除标准
- •Subject is taking medication that may have effect on hair growth (i.e. hormones, minoxidil)
- •Subject had electrolysis treatment within the last 6 months over the treatment area.
- •Subject had any type of professional intense pulsed light (IPL), laser or RF hair removal in the treatment site (with the exception of treatments within the OHR-2, OHR-2P, OHR2-1Y, OHR-3, or OHR-5-Face protocol).
研究组 & 干预措施
Maintenance
This arm receives Hair2Go treatments once a month for 6 months
干预措施: Hair2Go (Device)
结局指标
主要结局
Hair clearance at final follow up
时间窗: 1 year after last basic treatment (termination)
Hair clearance will be calculated at the final follow-up treatment from the hair counts conducted by independent blinded reviewer(s) based on photographs of treatment sites.
次要结局
未报告次要终点