The Effects of Hyaluronic Acid on Skin Health

NCT07542132 | Not Yet Recruiting

• 1 other identifier: HYDROHEALTH
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Skin Health

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Differences in skin microarchitecture

  4 ± 1 weeks post-injection

• Differences in skin external appearance

  4 ± 1 weeks post-injection

• Differences between female and male participants

  4 ± 1 weeks post-injection

Study Arms (3)

Control 1

NO INTERVENTION

Control 2

SHAM COMPARATOR

Other: Intracutaneous needle insertion

Formulation

EXPERIMENTAL

Device: Intracutaneous administration of a hyaluronic acid (HA)-based formulation

Interventions

Intracutaneous administration of a hyaluronic acid (HA)-based formulation DEVICE

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.

Formulation

Intracutaneous needle insertion OTHER

Intracutaneous needle insertion without product administration

Control 2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Informed Consent signed by the subject
• Ability and willingness to comply with all study procedures and visits as required by the protocol.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hans Laubach: lead

Study Sites (1)

Geneva University Hospitals (HUG)

Geneva, 1201, Switzerland

Location

Central Study Contacts

Hans Joachim Laubach, MD

CONTACT

+41 22 372 9450; hlau@hug.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Laser Dermatology Unit

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: April 21, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• 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.
• 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.

Locations

CH (1)