NCT06431464

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2024

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

February 19, 2024

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 28, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

May 28, 2024

Status Verified

May 1, 2024

Enrollment Period

5 months

First QC Date

February 19, 2024

Last Update Submit

May 27, 2024

Conditions

Tattoo; Pigmentation

Outcome Measures

Primary Outcomes (4)

  • Size of intercellular spaces

    Size of intercellular spaces after picosecond or nanosecond laser treatment.

    6 weeks and 12 weeks post-treatment

  • Size of keratinocytes

    Size of keratinocytes after picosecond or nanosecond laser treatment.

    6 weeks and 12 weeks post-treatment

  • Size of tattoo particles

    Size of tattoo particles after picosecond or nanosecond laser treatment.

    6 weeks and 12 weeks post-treatment

  • Distribution of tattoo particles

    Distribution though the epidermal and dermal layers after picosecond or nanosecond laser treatment.

    6 weeks and 12 weeks post-treatment

Study Arms (2)

Nanosecond laser

Patients with unwanted tattoos who plan a nanosecond laser treatment will be recruited for measurements using a multiphoton-tomography system.

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.

Other: picosecond laser treatment + measurement with a multiphoton tomography system

Interventions

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.

Picosecond laser
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.

Nanosecond laser

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

\- healthy patients who plan a laser treatment of their unwanted tattoo/ tattoos at our department

You may qualify if:

  • \- healthy patients who plan a laser treatment of their unwanted tattoo/ tattoos at our department

You may not qualify if:

  • laser pretreatment of their tattoos to be treated
  • pregnancy, breast feeding
  • open wound on the area to be treated

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Hamburg-Eppendorf

Hamburg, 20251, Germany

RECRUITING

Related Publications (2)

  • 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.

    PMID: 35837813BACKGROUND

  • Nguyen 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.

    PMID: 41137607DERIVED

MeSH Terms

Interventions

Weights and Measures

Intervention Hierarchy (Ancestors)

Investigative Techniques

Central Study Contacts

Lynhda Nguyen, Dr. med.

CONTACT

+49 (0) 7410-0l.ngyuen@uke.de

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

February 19, 2024

First Posted

May 28, 2024

Study Start

February 1, 2024

Primary Completion

June 30, 2024

Study Completion

July 31, 2024

Last Updated

May 28, 2024

Record last verified: 2024-05

Locations

DE(1)