Aging SkinNCT06431282
Hyaluronic Acid Delivery: CO2 Laser Versus Thulium Laser Treatment
A study testing CO2 laser + HA and Thulium laser + HA in people with Aging Skin, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging Skin
- What is being tested?
- CO2 laser + HA and Thulium laser + HA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 20 Feb 2024to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy male and female patients
Who cannot join
- pregnancy, breast feeding
- open wounds at the area to be treated
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Medical-Center Hamburg-Eppendorf
Hamburg, 20251
Lynhda Nguyen, Dr. med., +49 (0)40 7410-0, l.nguyen@uke.de
About this study
Official title: 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.
- Conditions
- Aging Skin
- Being tested
- CO2 laser + HA, Thulium laser + HA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| CO2 laser + HA | Active comparator | Probands are treated with a CO2 laser. Afterwards a HA gel will be applied. Receives: Other: CO2 laser + HA |
| Thulium laser + HA | Active comparator | Probands are treated with a thulium laser. Afterwards a HA gel will be applied. Receives: Other: Thulium laser + HA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Size of intercellular spaces
Size of intercellular spaces after CO2 or thulium laser treatment compared to control.
Measured: 30 minutes and 30 days after treatment.
Size of keratinocytes
Size of keratinocytes after CO2 or thulium laser treatment compared to control.
Measured: 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.
Measured: 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.
Measured: 30 minutes and 30 days after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2024
- Study start20 Feb 2024
- Primary completion31 May 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aging SkinStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lynhda Nguyen, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06431282
- Sponsor's protocol ID
- 01-24
- Status last verified
- May 2024
- First submitted
- 19 Feb 2024
- Last updated
- 28 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35837813
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Visualisation of Hyaluronic Acid After CO2 Laser Compared to Thulium Laser Treatment
- ClinicalTrials.gov ID
- NCT06431282
- Acronym / sponsor ID
- 01-24
- Conditions
- Aging Skin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 20 Feb 2024 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 28 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CO2 laser + HA | Active comparator | Other: CO2 laser + HAProbands are treated with a CO2 laser. Afterwards a HA gel will be applied. |
| Thulium laser + HA | Active comparator | Other: Thulium laser + HAProbands are treated with a thulium laser. Afterwards a HA gel will be applied. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy male and female patients
Key exclusion criteria (2 listed)
- pregnancy, breast feeding
- open wounds at the area to be treated
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CO2 laser + HAProbands 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. | Other | CO2 laser + HA |
| Thulium laser + HAProbands 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. | Other | Thulium laser + HA |
Primary outcome
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.
Size of keratinocytes
Time frame: 30 minutes and 30 days after treatment.
Size of keratinocytes after CO2 or thulium laser treatment compared to control.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2024.
- Background: PubMed 35837813Nguyen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CO2 laser + HA and Thulium laser + HA in people with Aging Skin, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Size of intercellular spaces (time frame: 30 minutes and 30 days after treatment.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06431282, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2024.