Clinical trial NCT05877833: Evaluating the Safety and Performance Characteristics of Ephemeral® Tattoo Ink in Healthy Subjects
Official title: An Open-Label, Single-Center, Prospective, Observational, Clinical Use Study Evaluating the Safety and Performance Characteristics of Ephemeral® Tattoo Ink in Healthy Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tattoo; Pigmentation
Lead sponsor: Ephemeral Solutions Inc.
Sponsor class: INDUSTRY
First posted: 2023-05-26
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy Adults

Brief summary: An Open-Label, Single-Center, Prospective, Observational, Clinical Use Study Evaluating the Safety and Performance Characteristics of Ephemeral® Tattoo Ink in Healthy Subjects

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants with tattoo vibrancy of 50% or greater
timeFrame: 3 months
Secondary outcomes:
measure: To evaluate the degree of healing of EPHEMERAL® TATTOO Ink
timeFrame: 3 months
Other outcomes:
Locations:
city: Milford
country: United States
facility: Brennal Pierre
state: Connecticut
Study officials:
References: