Evaluating the Safety and Performance Characteristics of Ephemeral® Tattoo Ink in Healthy Subjects (NCT05877833) | Clinical Trial Compass
CompletedNot Applicable
Evaluating the Safety and Performance Characteristics of Ephemeral® Tattoo Ink in Healthy Subjects
United States45 participantsStarted 2020-08-10
Plain-language summary
An Open-Label, Single-Center, Prospective, Observational, Clinical Use Study Evaluating the Safety and Performance Characteristics of Ephemeral® Tattoo Ink in Healthy Subjects
Who can participate
Age range18 Years – 60 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* â—Ź 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:
* â—Ź 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 h…
What they're measuring
1
Number of participants with tattoo vibrancy of 50% or greater