## Protocol Section
### Identification Module
**NCT ID:** NCT06431282

**Brief Title:** Hyaluronic Acid Delivery: CO2 Laser Versus Thulium Laser Treatment

**Official Title:** In Vivo Visualisation of Hyaluronic Acid After CO2 Laser Compared to Thulium Laser Treatment

#### Organization Study ID Info
**ID:** 01-24
#### Organization
**Class:** OTHER
**Full Name:** Universitätsklinikum Hamburg-Eppendorf
### Status Module
#### Completion Date
**Date:** 2024-06-30

**Type:** ESTIMATED

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

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-26

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-05-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-02-20

**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:** 2024-05-26
### 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:** * Weakly crossed-linked hyaluronic acid (HA) can be delivered through multiple injections into the dermal and subnormal layer to improve skin quality. However, this treatment comes with multiple bumps for several days.
* Alternatively, HA can be delivered after CO2 laser or thulium laser pretreatment. As microscopic analysis after this treatment is limited, the object of the present study is to investigate the morphological cellular changes after CO2 laser and thulium laser delivered HA into human skin.

### Conditions Module

**Conditions:**

- Aging Skin

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 30

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Probands are treated with a CO2 laser. Afterwards a HA gel will be applied.

**Intervention Names:**

- Other: CO2 laser + HA

**Label:** CO2 laser + HA

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Probands are treated with a thulium laser. Afterwards a HA gel will be applied.

**Intervention Names:**

- Other: Thulium laser + HA

**Label:** Thulium laser + HA

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- CO2 laser + HA

**Description:** Probands will be treated with a CO2 laser. Afterwards a HA gel will be applied. To measure microscopic cellular changes, a multiphoton tomography will be used.

**Name:** CO2 laser + HA

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Thulium laser + HA

**Description:** Probands will be treated with a thulium laser. Afterwards a HA gel will be applied. To measure microscopic cellular changes, a multiphoton tomography will be used.

**Name:** Thulium laser + HA

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Size of intercellular spaces after CO2 or thulium laser treatment compared to control.

**Measure:** Size of intercellular spaces

**Time Frame:** 30 minutes and 30 days after treatment.

**Description:** Size of keratinocytes after CO2 or thulium laser treatment compared to control.

**Measure:** Size of keratinocytes

**Time Frame:** 30 minutes and 30 days after treatment.

**Description:** Size of HA granules after CO2 or thulium laser treatment compared to control.

**Measure:** Size of hyaluronic acid granules

**Time Frame:** 30 minutes and 30 days after treatment.

**Description:** Distribution though the epidermal and dermal layers after CO2 or thulium laser treatment compared to control.

**Measure:** Distribution of Hyaluronic Acid

**Time Frame:** 30 minutes and 30 days after treatment.

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

- healthy male and female patients

Exclusion Criteria:

* pregnancy, breast feeding
* open wounds at the area to be treated

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Hamburg

**Contacts:**

***Contact 1:***

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

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

- **Phone:** +49 (0)40 7410-0

- **Role:** CONTACT

**Country:** Germany

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

**Status:** RECRUITING

**Zip:** 20251

### IPD Sharing Statement Module

**IPD Sharing:** NO

### 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

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M9878

- Name: Hyaluronic Acid

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
