Skin HealthHYDROHEALTHNCT07542132
The Effects of Hyaluronic Acid on Skin Health
A study testing Intracutaneous administration of a hyaluronic acid (HA)-based formulation and Intracutaneous needle insertion in people with Skin Health, run by Hans Laubach at 1 site in Switzerland.
Trial summary
As people age, skin health gradually changes. The structure and function of the skin are modified, its ability to regenerate decreases, and certain biological changes may accumulate over time. These processes can make the skin more fragile and more sensitive to certain diseases, including skin cancer. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Health
- What is being tested?
- Intracutaneous administration of a hyaluronic acid (HA)-based formulation and Intracutaneous needle insertion
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 8 Oct 2026to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Informed Consent signed by the subject
- Healthy adult volunteers aged 18 to 50 years at the time of inclusion
- Ability and willingness to comply with all study procedures and visits as required by the protocol.
Who cannot join
- Pregnant or breastfeeding women, or women unwilling to use an effective method of contraception, as the use of the investigational medical device is contraindicated according to the Instructions for Use (IFU)
- Known hypersensitivity to any of the product ingredients, as well as fructose intolerance.
- Any skin disease or systemic disease that, in the opinion of the investigator, may affect the treatment area or interfere with study assessments.
- Presence of any skin alteration at the test sites, including but not limited to scars, tattoos, or other visible skin lesions.
- History of hypertrophic scars or keloid formation or a similar abnormal wound healing.
- Presence of terminal hairs at the designated test sites.
Show all 12Show fewer
- Current use of any medication or treatment that, in the judgment of the investigator, may interfere with the interpretation of study results or pose a safety concern.
- Body Mass Index (BMI) > 36 kg/m².
- Any medical, psychological, psychiatric, or cognitive condition, including drug or alcohol abuse, language barriers, or other circumstances that, in the opinion of the investigator, may impair the subject's ability to understand the study information, comply with the investigation procedures, or complete the investigation.
- Participation in another clinical investigation involving an investigational medicinal product or medical device within the 30 days prior to enrolment.
- Previous enrolment in the current investigation.
- Enrolment of the principal investigator, sub-investigators, their family members, employees, or other dependent persons.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Geneva University Hospitals (HUG)
Geneva, 1201
Hans Joachim Laubach, MD, +41 22 372 9450, hlau@hug.ch
About this study
As people age, skin health gradually changes. The structure and function of the skin are modified, its ability to regenerate decreases, and certain biological changes may accumulate over time. These processes can make the skin more fragile and more sensitive to certain diseases, including skin cancer.
In dermatological and aesthetic practice, injectable formulations based on hyaluronic acid are widely used to improve skin quality. Although these products are generally well tolerated, their deeper biological effects are most often assessed through subjective clinical observations. Quantitative scientific data are therefore needed to better understand how these products affect the skin.
Read more
The aim of this study is to determine whether a hyaluronic acid-based formulation induces measurable changes in biological markers associated with skin health and fibroblast activity, which are important for skin regeneration. The study also examines whether these biological changes are accompanied by internal changes in skin structure.
For each participant, three skin areas located on the lower abdomen will be studied. One area will receive an injection of the medical device, a second area will undergo needle insertion without injection, and a third area will receive no intervention. The assignment of the interventions to the skin areas will be done by chance, similar to a coin toss. The participant will know which interventions are performed and on which areas, while the evaluators will not.
The study includes three visits over a period of approximately six weeks. Non-invasive examinations as well as three small skin biopsies will be performed. There is no direct benefit expected for participants. The risks are mainly local and temporary. The overall results of the study will be shared after its completion in the form of a summary written in language understandable to the general public.
- Conditions
- Skin Health
- Being tested
- Intracutaneous administration of a hyaluronic acid (HA)-based formulation, Intracutaneous needle insertion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracutaneous administration of a hyaluronic acid (HA)-based formulationDevice
A total volume of 50 µL of the hyaluronic acid-based formulation is injected intracutaneously into a defined 1 cm² area on the mesogastric-hypogastric region.
Intracutaneous needle insertionOther
Intracutaneous needle insertion without product administration
| Study group | Role | What they receive |
|---|---|---|
| Control 1 | No intervention | Not described |
| Control 2 | Sham comparator | Not described Receives: Other: Intracutaneous needle insertion |
| Formulation | Experimental | Not described Receives: Device: Intracutaneous administration of a hyaluronic acid (HA)-based formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression of skin health-related biomarkers
Expression of skin health-related biomarkers assessed by bulk RNA sequencing, comparing treated sites with untreated (control) sites.
Measured: 4 ± 1 weeks post-injection
Secondary outcomes (4)
Differences in skin microarchitecture
Differences in skin microarchitecture assessed by line-field confocal optical coherence tomography (LC-OCT), 20 MHz ultrasound imaging, and proteomic analysis, comparing treated sites with untreated (control) sites.
Measured: 4 ± 1 weeks post-injection
Differences in skin external appearance
Differences in skin external appearance through photographic documentation using the using the Dermobile system, comparing treated sites with untreated (control) sites.
Measured: 4 ± 1 weeks post-injection
Differences between female and male participants
Differences between female and male participants in the treated-versus-untreated (control) change in skin health-related biomarker expression.
Measured: 4 ± 1 weeks post-injection
Differences according to participant ancestry and skin phototype
Differences according to participant ancestry and skin phototype in the treated- versus-untreated changes across the primary and secondary outcome measures.
Measured: 4 ± 1 weeks post-injection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start8 Oct 2026
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin HealthStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hans Laubach
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hans Laubach, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07542132
- Sponsor's protocol ID
- HYDROHEALTH
- Acronym
- HYDROHEALTH
- Status last verified
- Oct 2026
- First submitted
- 14 Apr 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data relevant to the primary and secondary outcomes will be shared upon reasonable request. Data will be made available after publication of the study results, subject to ethical approval and data protection requirements.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Hyaluronic Acid on Skin Health
- ClinicalTrials.gov ID
- NCT07542132
- Acronym / sponsor ID
- HYDROHEALTH / HYDROHEALTH
- Conditions
- Skin Health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hans LaubachUniversity, hospital or other
- Study start
- 8 Oct 2026 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 21 Apr 2026 (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.
As people age, skin health gradually changes. The structure and function of the skin are modified, its ability to regenerate decreases, and certain biological changes may accumulate over time. These processes can make the skin more fragile and more sensitive to certain diseases, including skin cancer.
In dermatological and aesthetic practice, injectable formulations based on hyaluronic acid are widely used to improve skin quality. Although these products are generally well tolerated, their deeper biological effects are most often assessed through subjective clinical observations. Quantitative scientific data are therefore needed to better understand how these products affect the skin.
The aim of this study is to determine whether a hyaluronic acid-based formulation induces measurable changes in biological markers associated with skin health and fibroblast activity, which are important for skin regeneration. The study also examines whether these biological changes are accompanied by internal changes in skin structure.
For each participant, three skin areas located on the lower abdomen will be studied. One area will receive an injection of the medical device, a second area will undergo needle insertion without injection, and a third area will receive no intervention. The assignment of the interventions to the skin areas will be done by chance, similar to a coin toss. The participant will know which interventions are performed and on which areas, while the evaluators will not.
The study includes three visits over a period of approximately six weeks. Non-invasive examinations as well as three small skin biopsies will be performed. There is no direct benefit expected for participants. The risks are mainly local and temporary. The overall results of the study will be shared after its completion in the form of a summary written in language understandable to the general public.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control 1 | No intervention | – |
| Control 2 | Sham comparator | Other: Intracutaneous needle insertion |
| Formulation | Experimental | Device: Intracutaneous administration of a hyaluronic acid (HA)-based formulation |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Informed Consent signed by the subject
- Healthy adult volunteers aged 18 to 50 years at the time of inclusion
- Ability and willingness to comply with all study procedures and visits as required by the protocol.
Key exclusion criteria (12 listed)
- Pregnant or breastfeeding women, or women unwilling to use an effective method of contraception, as the use of the investigational medical device is contraindicated according to the Instructions for Use (IFU)
- Known hypersensitivity to any of the product ingredients, as well as fructose intolerance.
- Any skin disease or systemic disease that, in the opinion of the investigator, may affect the treatment area or interfere with study assessments.
- Presence of any skin alteration at the test sites, including but not limited to scars, tattoos, or other visible skin lesions.
- History of hypertrophic scars or keloid formation or a similar abnormal wound healing.
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 |
|---|---|---|
| Intracutaneous administration of a hyaluronic acid (HA)-based formulationA total volume of 50 µL of the hyaluronic acid-based formulation is injected intracutaneously into a defined 1 cm² area on the mesogastric-hypogastric region. | Device | Formulation |
| Intracutaneous needle insertionIntracutaneous needle insertion without product administration | Other | Control 2 |
Primary outcome
Expression of skin health-related biomarkers
Time frame: 4 ± 1 weeks post-injection
Expression of skin health-related biomarkers assessed by bulk RNA sequencing, comparing treated sites with untreated (control) sites.
4 secondary outcomes
Differences in skin microarchitecture
Time frame: 4 ± 1 weeks post-injection
Differences in skin external appearance
Time frame: 4 ± 1 weeks post-injection
Differences between female and male participants
Time frame: 4 ± 1 weeks post-injection
Differences according to participant ancestry and skin phototype
Time frame: 4 ± 1 weeks post-injection.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data relevant to the primary and secondary outcomes will be shared upon reasonable request. Data will be made available after publication of the study results, subject to ethical approval and data protection requirements.
Related trials for Skin Health
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Enrolling by invitationPhase 2
Deployment and Evaluation of Humanoid Robotics in Coalition-Aligned Clinical Care Settings
Mobility Impairment, Clinical Workflow Optimization
RecruitingObservational study
Studies of Skin Microbes in Healthy People and in People With Skin Conditions
Eczema, Atopic Dermatitis
Not yet recruiting
Assessing Psoriasis Treatment Outcomes
Psoriasis
RecruitingObservational study
A Multilevel Approach to Connecting Underrepresented Populations to Clinical Trials
Cancer
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intracutaneous administration of a hyaluronic acid (HA)-based formulation and Intracutaneous needle insertion in people with Skin Health, run by Hans Laubach at 1 site in Switzerland.
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 3 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 13 Oct 2026. 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 Switzerland. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hans Joachim Laubach, MD (+41 22 372 9450, hlau@hug.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expression of skin health-related biomarkers (time frame: 4 ± 1 weeks post-injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Oct 2026.