## Protocol Section
### Identification Module
**NCT ID:** NCT06431464

**Brief Title:** Tattoo Particles: Picosecond Laser Versus Nanosecond Laser

**Official Title:** In Vivo Analysis of Tattoo Particles After Picosecond Laser Compared to Nanosecond Laser

#### Organization Study ID Info
**ID:** 02-24
#### Organization
**Class:** OTHER
**Full Name:** Universitätsklinikum Hamburg-Eppendorf
### Status Module
#### Completion Date
**Date:** 2024-07-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-27

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-06-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-02-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-02-19
**Study First Submit QC Date:** 2024-05-27
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Universitätsklinikum Hamburg-Eppendorf

#### Responsible Party

**Investigator Affiliation:** Universitätsklinikum Hamburg-Eppendorf

**Investigator Full Name:** Lynhda Nguyen

**Investigator Title:** Principle investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Tattoo; Pigmentation

### Design Module

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 20

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Other: nanosecond laser treatment + measurement with a multiphoton tomography system

**Label:** Nanosecond laser

#### Arm Group 2

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

**Intervention Names:**

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

**Label:** Picosecond laser

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Picosecond laser

**Description:** 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.

**Name:** picosecond laser treatment + measurement with a multiphoton tomography system

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Nanosecond laser

**Description:** 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.

**Name:** nanosecond laser treatment + measurement with a multiphoton tomography system

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Size of intercellular spaces after picosecond or nanosecond laser treatment.

**Measure:** Size of intercellular spaces

**Time Frame:** 6 weeks and 12 weeks post-treatment

**Description:** Size of keratinocytes after picosecond or nanosecond laser treatment.

**Measure:** Size of keratinocytes

**Time Frame:** 6 weeks and 12 weeks post-treatment

**Description:** Size of tattoo particles after picosecond or nanosecond laser treatment.

**Measure:** Size of tattoo particles

**Time Frame:** 6 weeks and 12 weeks post-treatment

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

**Measure:** Distribution of tattoo particles

**Time Frame:** 6 weeks and 12 weeks post-treatment

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

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

Exclusion Criteria:

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

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** - healthy patients who plan a laser treatment of their unwanted tattoo/ tattoos at our department

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** l.ngyuen@uke.de

**Name:** Lynhda Nguyen, Dr. med.

**Phone:** +49 (0) 7410-0

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Hamburg

**Contacts:**

***Contact 1:***

- **Email:** l.nguyen@uke.de

- **Name:** L Nguyen, Dr. med.

- **Phone:** +49 (0)40-74100

- **Role:** CONTACT

**Country:** Germany

**Facility:** University Medical Center Hamburg-Eppendorf

**Status:** RECRUITING

**Zip:** 20251

### References Module

#### References

**Citation:** 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:** 35837813

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
