NCT05877833已完成不适用
An Open-Label, Single-Center, Prospective, Observational, Clinical Use Study Evaluating the Safety and Performance Characteristics of Ephemeral® Tattoo Ink in Healthy Subjects
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Number of participants with tattoo vibrancy of 50% or greater
研究概览
简要总结
An Open-Label, Single-Center, Prospective, Observational, Clinical Use Study Evaluating the Safety and Performance Characteristics of Ephemeral® Tattoo Ink in Healthy Subjects
详细描述
Study product will be applied at the baseline visit by a skilled tattoo artist. The tattoo design will be approximately 2 inches x 2 inches and will consist of line work. No filling or shading will be included in the design.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •● Subjects who are able to give voluntary, written informed consent to participate in this study and from whom consent has been obtained including HIPAA authorization.
- •Healthy adults between 18 and 60 years of age.
- •Subjects with Fitzpatrick photo skin types I-VI.
- •Subjects who agree not to have any procedures affecting skin quality of the arm (Ex. Other tattoo within 2 inches of border of investigational ink, microdermabrasion, acne treatments, hair removal) for the duration of the study.
- •Subjects who understand this study and are able to follow study instructions and are willing to attend the required study visits.
- •Subjects who agree to be photographed for research reasons and their identity may not be concealed in these photographs.
- •Subjects who are willing not to publicize their EPHEMERAL® TATTOO on social media or through any web platform.
排除标准
- •● Subjects who are pregnant, planning to become pregnant or breastfeeding within 16 weeks of participation.
- •Subjects of childbearing potential who are not using an approved method of birth control (oral contraceptives, IUD, contraceptive implant, barrier methods with spermicide or abstinence). Females of non-childbearing potential are defined as post-menopausal (absence of menstrual bleeding for one year), hysterectomy or bilateral oophorectomy.
- •Subjects who cannot understand or are not willing to comply with the requirements of the study.
- •Subjects who have had any procedures affecting skin quality of the arm (Ex. Other tattoo within 2 inches of border of investigational ink, microdermabrasion, acne treatments, hair removal) in the 4 months prior to enrollment.
- •Subjects who have had recent extreme sun exposure to the treatment area (as defined by investigator)
- •Subjects who do not agree to avoid using tanning beds or intensive exposure to the sun for the duration of the study and within two weeks of initiating participation.
- •Subjects who have any dermatologic conditions including acne, rosacea, eczema, psoriasis, actinic keratosis, severe sun damage, infection or scars within the treatment area.
- •Subjects who have an active inflammatory process (skin eruptions such as cysts, pimples, rashes or hives) or infection within the treatment area.
- •Subjects currently taking, or with plans to start, any medication or supplement that may affect clotting, increase risk of infection or cause increased bleeding (Ex: Humira, fish oil, ginseng, aspirin, heparin, warfarin, recent inoculation/flu shot), to be determined by investigator.
- •Subjects who have any known cancer including skin cancers (basal cell carcinoma, squamous cell carcinoma and melanoma) in the treatment area.
- •Subjects who have an existing medical condition that the Investigator considers may put the subject at risk or compromise their participation in the study.
- •Subjects who have participated in another research study in the past 30 days.
- •Subjects who are currently involved in any injury litigation claims.
结局指标
主要结局
Number of participants with tattoo vibrancy of 50% or greater
时间窗: 3 months
To confirm that EPHEMERAL® TATTOO Ink formulation 1 and formulation 2 are able to meet and maintain vibrancy of 50% during the first 3 months after tattoo is applied
次要结局
- To evaluate the degree of healing of EPHEMERAL® TATTOO Ink(3 months)
研究者
研究点 (1)
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