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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Healthy Skin

Intervention / Treatment
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* Other: Treatment with petrolatum


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteers and/or with stable chronic condition (e.g. controlled hypertension) Female, 65 to 85 years, Caucasian, Phototype I to III according to the Fitzpatrick classification, Body Mass Index between 20 and 28 kg/m2, Non-smoker of at least one year, Absence of skin diseases or scars in the skin area of interest, Absence of tattoos in the skin area of interest, Able to give written informed consent, Willing and able to fulfill the study requirements Exclusion Criteria: Known or suspected defect of healing, Diabetes mellitus Any acute or chronic pathology that may interfere with the trial conduct, from investigator point of view, Acute or chronic wounds in the skin area of interest, Any skin affection which may interfere with the trial assessment, like urticaria,, psoriasis or scar on investigational areas, Medical history of skin cancer, History or establishment of diabetes or pre-diabetes, Any hyper-sensibility to one of the compounds of the investigational product, Any regular treatment which may affect the blood coagulation and hemostasis (anticoagulant medications, NSAID, etc.) before the suction blister induction (Visit 3 and Visit 5), one NSAID to treat headache within four days is allowed Any physical treatment (like laser or surgery) on the arms within the last 6 months, Use of topical or systemic treatment on the investigational areas within the past 4 weeks (topical hyaluronan, anti-inflammatory drugs, corticoids, retinoids, vitamin C, etc.) that would interfere with assessment and/or investigational treatments, Allergy to band-aid or to metals (such as nickel), UV sessions or strong sun exposure of the arms during the study period, Subject who cannot be contacted easily in case of necessity, Current participation in any other clinical study

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment with petrolatum<br>In each healthy volunteer, one of the two forearms is randomly assigned to the intervention. This forearm is treated with petrolatum for 4 respectively 8 weeks. | Other: Treatment with petrolatum<br>* Petrolatum is applied twice daily to the intervention arm.<br>|
| No Intervention: Control<br>The control forearm will remain untreated throughout the study. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blistering Time at Day 28±2 | Duration from the start of suction pressure to the development of a full blister (measured in minutes) | Day 28±2 | 
| Blistering Time at Day 56±2 | Duration from the start of suction pressure to the development of a full blister (measured in minutes) | Day 56±2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Epidermal Thickness | Optical coherence tomography (OCT) will be used to quantitatively measure changes of the epidermal thickness on the volar forearm | Baseline, Day 14±1, Day 28±2, Day 42±2, Day 56±2, Day 66±3 | 
| Change from Baseline in Epidermal Hydratation, Measurements Per Skin Area in Percentage (%) at the volar forearm | Epidermal moisture (measurement depth 0,5mm) was measured using MoistureMeterEpiD (Delfin Technologies Ltd.). The values are expressed in percentage of local tissue water (0 to 100 %). | Baseline, Day 14±1, Day 28±2, Day 42±2, Day 56±2, Day 66±3 | 
| Change from Baseline in Stratum Corneum Hydration (SCH), measured in Arbitrary Units (AU) | Corneometer® CM 825 (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure Stratum Corneum Hydration (SCH) in arbitrary units (AU) (range 0-120 AU) on the volar forearm. Lower values represent reduced skin hydration in the upper skin layer. | Baseline, Day 14±1, Day 28±2, Day 42±2, Day 56±2, Day 66±3 | 
| Skin surface Temperature | Measurement of the skin surface temperature on the volar forearm | Day 28±2 | 
| Skin surface Temperature | Measurement of the skin surface temperature on the volar forearm | Day 56±2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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skin ageing, suction blister, dermo-epidermal junction