NCT05877833

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 45 (actual)
• Sponsor: Ephemeral Solutions Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Tattoo; Pigmentation

Interventions

Type	Name	Description
OTHER	Vibrancy Assessment	Additionally, important medical events that may not result in death, be life threatening, or require hospitalization may be considered SAEs when, based on appropriate medical judgment, they may jeopardize the subject and may require medical or surgical intervention to prevent one of the outcomes listed above.

Timeline

• Start date: 2020-08-10
• Primary completion: 2023-02-01
• Completion: 2023-02-01
• First posted: 2023-05-26
• Last updated: 2023-05-30

Locations

1 site across 1 country: United States