The Effects of Hyaluronic Acid on Skin Health
Zusammenfassung der Studie
As we age, skin health gradually evolves. Its structure and function change, its regenerative capacity decreases, and certain biological alterations may accumulate. These changes 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 they are generally well tolerated, their profound biological effects are most often assessed using subjective clinical observations. Therefore, quantitative scientific data is needed to better understand their effects on the skin.
This study aims to determine whether a hyaluronic acid-based formulation induces measurable changes in biomarkers associated with skin health and the activity of fibroblasts, which are important cells for skin regeneration. It also examines whether these biological changes are accompanied by internal modifications of the skin structure.
In 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 will receive a needle insertion without injection, and a third will receive no intervention. The allocation of interventions to the areas will be done like a random draw, comparable 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 approximately six weeks. Non-invasive examinations as well as three skin biopsies of 3 mm will be performed. There is no direct benefit expected for the participants. The risks are mainly local and temporary. Overall results will be communicated in a summary understandable to the general public after the end of the study.
(BASEC)
Untersuchte Intervention
The intervention studied in this research project consists of the intracutaneous (in the skin) administration of a hyaluronic acid-based formulation, corresponding to the medical device STYLAGE® HydroMax, manufactured by Laboratoires VIVACY (Archamps, France). This is a certified medical device authorized in Switzerland, already used in dermatological practice.
Hyaluronic acid is a substance naturally present in human skin. It plays an important role in tissue hydration, skin structure, and the biological environment of skin cells. In dermatology and aesthetic medicine, hyaluronic acid-based formulations have been used for many years to improve certain aspects of skin quality, with a generally favorable tolerance profile well known to healthcare professionals.
In the context of this study, the medical device is administered by an intracutaneous injection, that is, into the skin. The administration is performed during a single session, at the beginning of the study, under controlled and standardized conditions.
The intervention does not aim to provide a direct therapeutic benefit to participants, but to scientifically and quantitatively evaluate the biological and structural effects of this intervention on healthy skin.
(BASEC)
Untersuchte Krankheit(en)
The skin is the largest organ of the human body and plays an essential role in protecting the body from external aggressions. It performs several important biological functions, including a barrier function, regulation of water balance, local immune defense, as well as the ability to repair and regenerate tissues after an aggression or injury. Skin health corresponds to the state in which these functions are maintained optimally, allowing the skin to retain its structure, resistance, and biological balance.
As we age, the structure and function of the skin may gradually evolve. Some biological processes become less effective, regenerative capacity decreases, and changes may appear at the level of skin cells and their supporting tissue. In particular, DNA repair mechanisms may become less efficient, leading to a gradual accumulation of cellular damage over time. These alterations make the skin more fragile, may modify its response to environmental aggressions, and increase its sensitivity to certain skin conditions, including, in the long term, skin cancer. Understanding these mechanisms is an important issue for dermatological research, even in the absence of declared pathology.
This study therefore focuses on the condition of healthy skin, to examine whether the administration of a hyaluronic acid-based formulation can induce measurable changes in biological markers associated with skin health. These markers are linked to the activity of certain skin cells, particularly fibroblasts, which play a key role in maintaining skin structure and in repair processes. The study also aims to determine whether these biological changes are associated with internal modifications of the skin structure, observable using non-invasive imaging techniques.
It is important to emphasize that this study does not aim to diagnose, treat, or prevent a disease. It is not directed at patients with a dermatological condition, but at healthy adult volunteers. The expected results are scientific in nature and aim to improve the understanding of the biological mechanisms of healthy skin, as well as the methods of objective assessment of skin health.
The knowledge generated by this research could contribute, in the long term, to the development of more precise methods for assessing skin health and to better understand the impact of certain interventions on its biology and structure.
(BASEC)
Have signed the informed consent form
Be a healthy adult volunteer, aged 18 to 50 years at the time of inclusion
Be willing and able to follow all study procedures and attend all visits scheduled by the protocol
(BASEC)
Ausschlusskriterien
• Be pregnant or breastfeeding, or not wishing to use an effective method of contraception during the study, as the use of the studied medical device is not recommended in these situations
• Have a known allergy or hypersensitivity to hyaluronic acid
• Have a skin alteration at the study sites (e.g., a skin lesion), or suffer from a skin disease or a general illness that, in the opinion of the investigator, could affect the treated area, interfere with study assessments, or compromise proper healing
(BASEC)
Studienstandort
Genf
(BASEC)
Sponsor
Dr. med. LAUBACH, Hans-Joachim – Sponsor-Investigator clinical trial Service de Dermatologie Hôpitaux Universitaires de Genève, Rue Gabrielle-Perret-Gentil 4
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Dr. med. LAUBACH, Hans-Joachim
+41 22 372 9450
hans-joachim.laubach@clutterhug.chService de Dermatologie Hôpitaux Universitaires de Genève, Rue Gabrielle-Perret-Gentil 4
(BASEC)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Genf
(BASEC)
Datum der Bewilligung durch die Ethikkommission
26.08.2026
(BASEC)
ICTRP Studien-ID
NCT07542132 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
The Effects of Hyaluronic Acid on Skin Health (BASEC)
Wissenschaftlicher Titel
The Effects of Hyaluronic Acid on Skin Health (ICTRP)
Öffentlicher Titel
The Effects of Hyaluronic Acid on Skin Health (ICTRP)
Untersuchte Krankheit(en)
Skin Health
(ICTRP)
Untersuchte Intervention
Device: Intracutaneous administration of a hyaluronic acid (HA)-based formulationOther: Intracutaneous needle insertion
(ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
(ICTRP)
Ein-/Ausschlusskriterien
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/m.
- 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.
(ICTRP)
nicht verfügbar
Primäre und sekundäre Endpunkte
Expression of skin health-related biomarkers
(ICTRP)
Differences in skin microarchitecture;Differences in skin external appearance;Differences between female and male participants
(ICTRP)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
Hans Joachim Laubach, MDHans Joachim Laubach, MD, hlau@hug.chhlau@hug.ch, +41 22 372 9450+41 22 372 9450 (ICTRP)
Sekundäre IDs
HYDROHEALTH (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/study/NCT07542132 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar