Hyaluronic Acid Delivery: CO2 Laser Versus Thulium Laser Treatment

May 26, 2024 updated by: Lynhda Nguyen, Universitätsklinikum Hamburg-Eppendorf

In Vivo Visualisation of Hyaluronic Acid After CO2 Laser Compared to Thulium Laser Treatment

  • 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany, 20251
        • Recruiting
        • University Medical-Center Hamburg-Eppendorf
        • Contact:
          • Lynhda Nguyen, Dr. med.
          • Phone Number: +49 (0)40 7410-0
          • Email: l.nguyen@uke.de

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

- healthy male and female patients

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: CO2 laser + HA
Probands are treated with a CO2 laser. Afterwards a HA gel will be applied.
Other: CO2 laser + HA
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.
Active Comparator: Thulium laser + HA
Probands are treated with a thulium laser. Afterwards a HA gel will be applied.
Other: Thulium laser + HA
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Size of intercellular spaces
Time Frame: 30 minutes and 30 days after treatment.
Size of intercellular spaces after CO2 or thulium laser treatment compared to control.
30 minutes and 30 days after treatment.
Size of keratinocytes
Time Frame: 30 minutes and 30 days after treatment.
Size of keratinocytes after CO2 or thulium laser treatment compared to control.
30 minutes and 30 days after treatment.
Size of hyaluronic acid granules
Time Frame: 30 minutes and 30 days after treatment.
Size of HA granules after CO2 or thulium laser treatment compared to control.
30 minutes and 30 days after treatment.
Distribution of Hyaluronic Acid
Time Frame: 30 minutes and 30 days after treatment.
Distribution though the epidermal and dermal layers after CO2 or thulium laser treatment compared to control.
30 minutes and 30 days after treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2024

Primary Completion (Estimated)

May 31, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

February 19, 2024

First Submitted That Met QC Criteria

May 26, 2024

First Posted (Actual)

May 28, 2024

Study Record Updates

Last Update Posted (Actual)

May 28, 2024

Last Update Submitted That Met QC Criteria

May 26, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 01-24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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