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

Completed

• Conditions: Tattoo; Pigmentation
• Interventions: Other: Vibrancy Assessment

• Registration Number: NCT05877833
• Lead Sponsor: Ephemeral Solutions Inc.

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.

Study Timeline

• Study Start: 2020-08-10
• Primary Completion: 2023-02-01
• Study Completion: 2023-02-01
• Study First Submitted: 2023-03-07
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-17
• Last Update Submitted: 2023-05-25
• Study First Posted: 2023-05-26
• Last Update Posted: 2023-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Vibrancy	Vibrancy Assessment	Healthy adults

Primary Outcome Measures

Name	Time	Method
Number of participants with tattoo vibrancy of 50% or greater	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

Secondary Outcome Measures

Name	Time	Method
To evaluate the degree of healing of EPHEMERAL® TATTOO Ink	3 months	To evaluate the degree of healing of EPHEMERAL® TATTOO Ink as measured by the Investigator post-application healing assessment.

Trial Locations

Locations (1)

Brennal Pierre; 🇺🇸 Milford, Connecticut, United States