NCT05614557

Impact of Silicon-based Formulations on Wound Healing of Laser-induced Microscopic Skin Lesions

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Stratpharma AG · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

Delayed wound healing is considered a health problem with devastating consequences for patients, healthcare systems, and societies. Over the past 20 years, many other groups, as well as ourselves, have evaluated various alternatives to improve wound healing. Despite this, the scientific evidence demonstrating the efficacy of recently developed treatments is often limited. Stratacel® and Stratamed® are two gels approved by Swissmedic and the FDA for use in improving wound healing. To this end, the efficacy of these formulations has been visually tested by a physician or by patients. Using the most advanced medical technologies (confocal microscopy and LCOCT), this study aims to investigate the effect of these formulations on the healing of human skin. For this research, a total of 20 volunteers will be included in this study. Volunteers will have up to 7 follow-up appointments over 21 days. Each appointment will last approximately 30 minutes and will be used to perform external measurements of skin healing. All volunteers will use the same formulations (Stratacel® and Stratamed®) with the only difference between volunteers being the anatomical area of application of the formulation. This will be determined by chance. The active participation of the participant is requested for the application of the formulations on the skin twice a day during the trial.

Conditions

• Wound Healing

Interventions

Type	Name	Description
DEVICE	Stratacel	Silicone-based formulation registered as a European class IIa, TGA (Therapeutic Goods Administration) and FDA listed Class I medical device (wound dressing).
DEVICE	Stratamed	Silicone-based formulation registered as a European class IIa, TGA (Therapeutic Goods Administration) and FDA listed Class I medical device (wound dressing).

Timeline

• Start date: 2023-03-21
• Primary completion: 2023-08-31
• Completion: 2023-08-31
• First posted: 2022-11-14
• Last updated: 2023-09-06

Locations

1 site across 1 country: Switzerland