NCT06431282

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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

February 19, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

February 20, 2024

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 28, 2024

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

May 28, 2024

Status Verified

May 1, 2024

Enrollment Period

3 months

First QC Date

February 19, 2024

Last Update Submit

May 26, 2024

Conditions

Aging Skin

Outcome Measures

Primary Outcomes (4)

  • Size of intercellular spaces

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

    30 minutes and 30 days after treatment.

  • Size of keratinocytes

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

    30 minutes and 30 days after treatment.

  • Size of hyaluronic acid granules

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

    30 minutes and 30 days after treatment.

  • Distribution of Hyaluronic Acid

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

    30 minutes and 30 days after treatment.

Study Arms (2)

CO2 laser + HA

ACTIVE COMPARATOR

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

Other: CO2 laser + HA

Thulium laser + HA

ACTIVE COMPARATOR

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

Other: Thulium laser + HA

Interventions

CO2 laser + HAOTHER

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.

CO2 laser + HA
Thulium laser + HAOTHER

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.

Thulium laser + HA

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- healthy male and female patients

You may not qualify if:

  • pregnancy, breast feeding
  • open wounds at 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 (1)

  • 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

MeSH Terms

Interventions

Lasers, Gas

Intervention Hierarchy (Ancestors)

LasersOptical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
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 20, 2024

Primary Completion

May 31, 2024

Study Completion

June 30, 2024

Last Updated

May 28, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)