| Eligibility |
Inclusion Criteria:
- ? 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.
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.
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