Tattoo; PigmentationNCT06431464
Tattoo Particles: Picosecond Laser Versus Nanosecond Laser
An observational study of Tattoo; Pigmentation, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
For treating unwanted tattoos, the gold standard treatment is a nanosecond or picosecond laser. However, comparative microscopic analysis is limited. Therefore, the aim of the present study is to analysis morphological changes of tattoo particles and surrounding tissue in human skin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tattoo; Pigmentation
- What is being tested?
- picosecond laser treatment + measurement with a multiphoton tomography system and nanosecond laser treatment + measurement with a multiphoton tomography system
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 1 Feb 2024to 31 Jul 2024
- 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 years and older
- All sexes
- Adult, Older adult
Study population: - healthy patients who plan a laser treatment of their unwanted tattoo/ tattoos at our department
Who may be able to join
- healthy patients who plan a laser treatment of their unwanted tattoo/ tattoos at our department
Who cannot join
- laser pretreatment of their tattoos to be treated
- pregnancy, breast feeding
- open wound on the area to be treated
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Medical Center Hamburg-Eppendorf
Hamburg, 20251
L Nguyen, Dr. med., +49 (0)40-74100, l.nguyen@uke.de
About this study
Official title: In Vivo Analysis of Tattoo Particles After Picosecond Laser Compared to Nanosecond Laser
- For treating unwanted tattoos, the gold standard treatment is a nanosecond or picosecond laser. However, comparative microscopic analysis is limited. Therefore, the aim of the present study is to analysis morphological changes of tattoo particles and surrounding tissue in human skin.
- Conditions
- Tattoo; Pigmentation
- Being tested
- picosecond laser treatment + measurement with a multiphoton tomography system, nanosecond laser treatment + measurement with a multiphoton tomography system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
picosecond laser treatment + measurement with a multiphoton tomography systemOther
Patients with unwanted tattoos who plan a laser treatment will be recruited for measurements using a multiphoton-tomography system. These are scheduled 6 weeks and 12 weeks post-treatment.
nanosecond laser treatment + measurement with a multiphoton tomography systemOther
Patients with unwanted tattoos who plan a laser treatment will be recruited for measurements using a multiphoton-tomography system. These are scheduled 6 weeks and 12 weeks post-treatment.
| Study group | Role | What they receive |
|---|---|---|
| Nanosecond laser | Patients with unwanted tattoos who plan a nanosecond laser treatment will be recruited for measurements using a multiphoton-tomography system. Receives: Other: nanosecond laser treatment + measurement with a multiphoton tomography system | |
| Picosecond laser | Patients with unwanted tattoos who plan a picosecond laser treatment will be recruited for measurements using a multiphoton-tomography system. Receives: Other: picosecond laser treatment + measurement with a multiphoton tomography system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Size of intercellular spaces
Size of intercellular spaces after picosecond or nanosecond laser treatment.
Measured: 6 weeks and 12 weeks post-treatment
Size of keratinocytes
Size of keratinocytes after picosecond or nanosecond laser treatment.
Measured: 6 weeks and 12 weeks post-treatment
Size of tattoo particles
Size of tattoo particles after picosecond or nanosecond laser treatment.
Measured: 6 weeks and 12 weeks post-treatment
Distribution of tattoo particles
Distribution though the epidermal and dermal layers after picosecond or nanosecond laser treatment.
Measured: 6 weeks and 12 weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2024
- Study start1 Feb 2024
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Tattoo; PigmentationStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lynhda Nguyen, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06431464
- Sponsor's protocol ID
- 02-24
- Status last verified
- May 2024
- First submitted
- 19 Feb 2024
- Last updated
- 28 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nguyen L, Mess C, Schneider SW, Huck V, Herberger K. In vivo visualisation of tattoo particles using multiphoton tomography and fluorescence lifetime imaging. Exp Dermatol. 2022 Nov;31(11):1712-1719. doi: 10.1111/exd.14646. Epub 2022 Jul 25.
PubMed 35837813Nguyen L, Mess C, Huck V, Schneider SW, Herberger K. Intravital Visualization of Tattoo Particles After Picosecond Laser Treatment. Skin Res Technol. 2025 Oct;31(10):e70283. doi: 10.1111/srt.70283.
PubMed 41137607
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Analysis of Tattoo Particles After Picosecond Laser Compared to Nanosecond Laser
- ClinicalTrials.gov ID
- NCT06431464
- Acronym / sponsor ID
- 02-24
- Conditions
- Tattoo; Pigmentation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 28 May 2024 (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.
- For treating unwanted tattoos, the gold standard treatment is a nanosecond or picosecond laser. However, comparative microscopic analysis is limited. Therefore, the aim of the present study is to analysis morphological changes of tattoo particles and surrounding tissue in human skin.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nanosecond laser | – | Other: nanosecond laser treatment + measurement with a multiphoton tomography systemPatients with unwanted tattoos who plan a nanosecond laser treatment will be recruited for measurements using a multiphoton-tomography system. |
| Picosecond laser | – | Other: picosecond laser treatment + measurement with a multiphoton tomography systemPatients with unwanted tattoos who plan a picosecond laser treatment will be recruited for measurements using a multiphoton-tomography system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- - healthy patients who plan a laser treatment of their unwanted tattoo/ tattoos at our department
Key inclusion criteria (1 listed)
- healthy patients who plan a laser treatment of their unwanted tattoo/ tattoos at our department
Key exclusion criteria (3 listed)
- laser pretreatment of their tattoos to be treated
- pregnancy, breast feeding
- open wound on the area to be treated
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 |
|---|---|---|
| picosecond laser treatment + measurement with a multiphoton tomography systemPatients with unwanted tattoos who plan a laser treatment will be recruited for measurements using a multiphoton-tomography system. These are scheduled 6 weeks and 12 weeks post-treatment. | Other | Picosecond laser |
| nanosecond laser treatment + measurement with a multiphoton tomography systemPatients with unwanted tattoos who plan a laser treatment will be recruited for measurements using a multiphoton-tomography system. These are scheduled 6 weeks and 12 weeks post-treatment. | Other | Nanosecond laser |
Primary outcome
Size of intercellular spaces
Time frame: 6 weeks and 12 weeks post-treatment
Size of intercellular spaces after picosecond or nanosecond laser treatment.
Size of keratinocytes
Time frame: 6 weeks and 12 weeks post-treatment
Size of keratinocytes after picosecond or nanosecond laser treatment.
Size of tattoo particles
Time frame: 6 weeks and 12 weeks post-treatment
Size of tattoo particles after picosecond or nanosecond laser treatment.
Distribution of tattoo particles
Time frame: 6 weeks and 12 weeks post-treatment
Distribution though the epidermal and dermal layers after picosecond or nanosecond laser treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2024.
- Background: PubMed 35837813Nguyen L, Mess C, Schneider SW, Huck V, Herberger K. In vivo visualisation of tattoo particles using multiphoton tomography and fluorescence lifetime imaging. Exp Dermatol. 2022 Nov;31(11):1712-1719. doi: 10.1111/exd.14646. Epub 2022 Jul 25.
- Derived from this study: PubMed 41137607Nguyen L, Mess C, Huck V, Schneider SW, Herberger K. Intravital Visualization of Tattoo Particles After Picosecond Laser Treatment. Skin Res Technol. 2025 Oct;31(10):e70283. doi: 10.1111/srt.70283.
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.
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 Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 28 May 2024. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lynhda Nguyen, Dr. med. (+49 (0) 7410-0, l.ngyuen@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Size of intercellular spaces (time frame: 6 weeks and 12 weeks post-treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06431464, which also lists 2 linked publications.
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 28 May 2024.