Study on the effects of silicone-based gel formulations on the healing of microscopic skin lesions induced by laser

Zusammenfassung der Studie

Abnormal wound healing is considered a health issue with devastating consequences for patients, healthcare systems, and societies. Over the past 20 years, we and many other groups have evaluated various alternatives to improve their healing. Nevertheless, scientific evidence demonstrating the effectiveness of recently developed treatments is often limited. Stratacel and Stratamed are two gels approved in Switzerland for use aimed at improving wound healing. To this end, the effectiveness of these formulations has been visually tested by a physician or through patient feedback. Using the most advanced medical technologies, the aim of this study is to investigate the effect of these formulations on the healing of human skin. We would like to include a total of 20 volunteers in this study. Volunteers will have up to 7 appointments in 21 days. Each appointment will last approximately 30 minutes and will serve to perform external measurements of skin healing. All volunteers will use the same formulations (Stratacel and Stratamed), the only difference between the volunteers will be the location where each formulation will be applied. This will be determined randomly. The active participation of the participant is requested through the application of the formulations on the skin twice a day for the duration of the trial.

(BASEC)

Untersuchte Intervention

Stratacel and Stratamed are two gels approved in Switzerland for use aimed at improving wound healing. By forming a protective film over the wound, they ensure an optimal environment for faster healing while protecting the lesion from microbial invasion. As they remain outside the wounds, Stratacel and Stratamed are well tolerated and no discomfort or infection has been reported. After an initial appointment with the volunteers, confirming that they meet the criteria to participate in the study, three applications of CO2 laser will be performed on one of the forearms. Each of these applications generates a set of micro-lesions in a very small area (barely visible to the naked eye). In two of these areas, the volunteer will apply the aforementioned formulations twice a day for 21 days (one in each area). They will leave a third area free of formulation. During the period of up to 7 appointments in 21 days, several measurements (level of irritation, wound structure, and photographic documentation) will be performed and the differences in the healing process will be evaluated. The physician and the volunteer are aware of the treatment they are receiving, but the person conducting the measurements and the person analyzing the data are unaware of this information.

(BASEC)

Untersuchte Krankheit(en)

The skin is the largest organ of the human body. One of its various responsibilities is to protect us from shocks, infections, radiation, and chemical damage. Therefore, the skin is very exposed to damage such as cuts, scrapes, tears, and/or burns. Regardless of the damage sustained, the skin tries to recover as quickly as possible in order to continue protecting us. If the healing of the skin does not occur within a timeframe considered "normal", it is deemed to be abnormal wound healing. Abnormal wound healing is regarded as a health issue with devastating consequences for patients, healthcare systems, and societies. However, scientific evidence demonstrating the effectiveness of recently developed treatments is often limited.

(BASEC)

Sponsor

Stratpharma AG Aeschenvorstadt, 57 4051 Basel

(BASEC)

Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)

Ethikkommission Genf

(BASEC)

Datum der Bewilligung durch die Ethikkommission

09.03.2023

(BASEC)

Ergebnisse der Studie