The Effects of Hyaluronic Acid on Skin Health

ConditionSkin Health
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorHans Laubach

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Intracutaneous administration of a hyaluronic acid (HA)-based formulation
  • Intracutaneous needle insertion

Treatment groups

20 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Hans Laubach

Lead sponsor

University Hospital, Geneva

Sponsor institution