Tattoo; PigmentationNCT05877833
Evaluating the Safety and Performance Characteristics of Ephemeral® Tattoo Ink in Healthy Subjects
An observational study of Tattoo; Pigmentation, run by Ephemeral Solutions Inc. at 1 site in United States.
Trial summary
An Open-Label, Single-Center, Prospective, Observational, Clinical Use Study Evaluating the Safety and Performance Characteristics of Ephemeral® Tattoo Ink in Healthy Subjects Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Tattoo; Pigmentation
- What is being tested?
- Vibrancy Assessment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Aug 2020to 1 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy Adults
Who may be able to join
- ● 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.
Who cannot join
- ● 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
An Open-Label, Single-Center, Prospective, Observational, Clinical Use Study Evaluating the Safety and Performance Characteristics of Ephemeral® Tattoo Ink in Healthy Subjects
Read the 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
- Being tested
- Vibrancy Assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibrancy AssessmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Vibrancy | Healthy adults Receives: Other: Vibrancy Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with tattoo vibrancy of 50% or greater
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
Measured: 3 months
Secondary outcomes (1)
To evaluate the degree of healing of EPHEMERAL® TATTOO Ink
To evaluate the degree of healing of EPHEMERAL® TATTOO Ink as measured by the Investigator post-application healing assessment.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start10 Aug 2020
- Primary completion1 Feb 2023
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tattoo; PigmentationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ephemeral Solutions Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05877833
- Sponsor's protocol ID
- EPHEM-001
- Status last verified
- May 2023
- First submitted
- 7 Mar 2023
- Last updated
- 30 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05877833
- Acronym / sponsor ID
- EPHEM-001
- Conditions
- Tattoo; Pigmentation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Ephemeral Solutions Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Aug 2020 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 26 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vibrancy | – | Other: Vibrancy AssessmentHealthy adults |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy Adults
Key inclusion criteria (7 listed)
- ● 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.
Key exclusion criteria (13 listed)
- ● Subjects who are pregnant, planning to become pregnant or breastfeeding within 16 weeks of participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vibrancy AssessmentAdditionally, 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. | Other | Vibrancy |
Primary outcome
Number of participants with tattoo vibrancy of 50% or greater
Time frame: 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
1 secondary outcome
To evaluate the degree of healing of EPHEMERAL® TATTOO Ink
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tattoo; Pigmentation, run by Ephemeral Solutions Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with tattoo vibrancy of 50% or greater (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2023.