Geneva University Hospitals (HUG)
Geneva, 1201, Switzerland
NCT Number: NCT07542132
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.
Trial opening soon.
Get Notified18 year–50 year
All sexes
Interventional
Not applicable
Geneva, 1201, Switzerland
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 insertion without product administration
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.
Time frame: 4 ± 1 weeks post-injection
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.
Time frame: 4 ± 1 weeks post-injection
Differences in skin external appearance through photographic documentation using the using the Dermobile system, comparing treated sites with untreated (control) sites.
Time frame: 4 ± 1 weeks post-injection
Differences between female and male participants in the treated-versus-untreated (control) change in skin health-related biomarker expression.
Contact information is provided by the study sponsor or research team.
Hans Laubach
Other
Acronym: HYDROHEALTH
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06971029
Collagen Supplementation, Growth Factors
View Trial DetailsNCT07703215
Antioxidant Capacity, Atopic Dermatitis
Cheras, Kuala Lumpur, Malaysia
View Trial DetailsNCT07271199
Eyelash Growth, Eyelashes
Taichung, Taiwan
View Trial DetailsNCT07341087
Acne, Acne Vulgaris
London, United Kingdom
View Trial Details