Effect of a Basic Skin Care Product on the Structural Strength of the Skin

Healthy Skin Clinical Trial

Official title: An Exploratory Randomized Controlled Study to Evaluate the Effect of a Basic Skin Care Product on the Structural Strength of the Dermo-epidermal Junction

Status Completed

Clinical Trial Summary

The main aim of this study is to investigate in a suction blister model, whether the use of a basic skin care formulation increases the mechanical integrity/adhesion of the dermo-epidermal junction.

Clinical Trial Description

The process of aging involves numerous structural and functional changes also affecting the skin. The skin fulfills a variety of protective and regulatory functions. Compared to other organs, the skin is constantly exposed to harmful environmental influences. Besides intrinsic factors these external factors may accelerate skin aging. Due to its ageing-related loss of functional capacity the skin becomes susceptible to develop adverse skin conditions and dermatological diseases (e.g. skin dryness, fungal infections). Especially old aged, care depended, and severely ill individuals are at high risk for developing severe skin injuries and wounds (e.g. decubitus, skin tears) with high social and economic impact. Empirical evidence indicates that the reduced adhesion of the dermal-epidermal junction is a major pathophysiological predictor for these types of injuries.

The suction blister model is an artificial and controlled technique for dermal-epidermal separation along the dermo-epidermal junction (DEJ). Empirical evidence suggests that the time of the dermal-epidermal separation (blistering time) is a measure of the dermo-epidermal adhesion. It has been proposed that the blistering time might be a clinically relevant parameter reflecting the mechanical integrity/stability of the dermo-epidermal junction.

Clinical practice guidelines recommend the use of topical skin care products to reduce the risk for pressure ulcer and skin tear development. However, the underlying working mechanisms of most basic skin care products are poorly understood. It is known that topically applied skin care products exhibit physical and chemical effects on and in the uppermost skin layers (e.g. the stratum corneum). Despite a few well known active ingredients (e.g. retinoids, vitamin C) exhibiting effects in the dermis, a particular skin protective effect of the vast majority of daily basic skin care applications on these deeper skin layers is unknown. The primary objective of this study is to test, whether the use of a basic skin care formulation increases the mechanical integrity/adhesion of the dermo-epidermal junction. ;

Related Conditions & MeSH terms

• Healthy Skin

• NCT number: NCT03625167
• Study type: Interventional
• Source: Charite University, Berlin, Germany
• Status: Completed
• Phase: N/A
• Start date: July 31, 2018
• Completion date: December 31, 2018