Evaluating the Safety and Performance Characteristics of Ephemeral® Tattoo Ink in Healthy Subjects

Exclusion Criteria

• •● 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.