The Effects of Hyaluronic Acid on Skin Health (HYDROHEALTH)

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 Overview

• Status: Not yet recruiting
• Conditions: Skin Health
• Intervention / Treatment: Other: Intracutaneous needle insertion; Device: Intracutaneous administration of a hyaluronic acid (HA)-based formulation

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hans Joachim Laubach, MD; Phone Number: +41 22 372 9450; Email: hlau@hug.ch

Study Locations

• Switzerland
  • Geneva, Switzerland, 1201
    • Geneva University Hospitals (HUG)
    • Contact: Hans Joachim Laubach, MD; Phone Number: +41 22 372 9450; Email: hlau@hug.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion criteria:

• 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.

Exclusion criteria:

• 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.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control 1
Sham Comparator: Control 2	Other: Intracutaneous needle insertion; Intracutaneous needle insertion without product administration
Experimental: Formulation	Device: Intracutaneous administration of a hyaluronic acid (HA)-based formulation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Expression of skin health-related biomarkers	Expression of skin health-related biomarkers assessed by bulk RNA sequencing, comparing treated sites with untreated (control) sites.	4 ± 1 weeks post-injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	4 ± 1 weeks post-injection

Collaborators and Investigators

• Sponsor: Hans Laubach

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: April 14, 2026
• First Submitted That Met QC Criteria: April 14, 2026
• First Posted (Actual): April 21, 2026

Study Record Updates

• Last Update Posted (Actual): April 27, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: HYDROHEALTH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: De-identified individual participant data and supporting documents will be available upon reasonable request starting after publication of the primary study results and for a period of five years thereafter.
• IPD Sharing Access Criteria: Access will be granted to qualified researchers with a legitimate scientific purpose. Requests must be submitted to the sponsor-investigator and will be evaluated based on scientific relevance, ethical approval, and compliance with data protection regulations. Only de-identified data related to the study outcomes will be shared, under a data use agreement.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No