Healthy Skin
Conditions
Keywords
skin ageing, suction blister, dermo-epidermal junction
Brief 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.
Detailed 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.
Interventions
OTHERTreatment with petrolatum
Petrolatum is applied twice daily to the intervention arm.
Sponsors
Prof. Dr. Jan Kottner
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
65 Years to 85 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blistering Time (Full Blister) | Day 28±2, Day 56±2 | Duration from the start of suction pressure to the development of a full blister (measured in minutes) |
| Blistering Time (First Vesicles) | Day 28±2, Day 56±2 | Duration from the start of suction pressure to the development of first macroscopically visible vesicles (measured in minutes) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Epidermal Thickness | Baseline, Day 28±2, Day 56±2 | Optical coherence tomography (OCT) will be used to quantitatively measure changes of the epidermal thickness on the volar forearm |
| Epidermal Hydratation: Stratum Corneum Hydration | Baseline, Day 14±1, Day 28±2, Day 42±2, Day 56±2 | Stratum corneum hydration (SCH) was measured with Corneometer® CM 825 (Courage & Khazaka electronic GmbH, Cologne, Germany) and expressed in arbitrary units (AU) (range 0-120 AU) on the volar forearm. Lower values represent reduced skin hydration in the upper skin layer. |
| Epidermal Hydratation: Epidermal Moisture | Baseline, Day 14±1, Day 28±2, Day 42±2, Day 56±2 | 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 %). |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Split-Body-Design on Both Forearms. Intervention: Treatment With Petrolatum; Control: No Treatment 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. | 12 |
| Split-Body-Design on Both Forearms. Intervention: Treatment With Petrolatum; Control: No Treatment 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. | 24 |
| Total | 36 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 5 |
Baseline characteristics
| Characteristic | Split-Body-Design on Both Forearms. Intervention: Treatment With Petrolatum; Control: No Treatment |
|---|---|
| Age, Continuous Age | 70.3 years STANDARD_DEVIATION 2.1 |
| Blood pressure Diastolic | 83 mmHg STANDARD_DEVIATION 9 |
| Blood pressure Systolic | 127 mmHg STANDARD_DEVIATION 16 |
| Body Mass Index (BMI) | 26.0 kg/m^2 STANDARD_DEVIATION 2.2 |
| Body temperature | 36.3 degree Celsius STANDARD_DEVIATION 0.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 12 Participants |
| Region of Enrollment Germany | 12 Participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 0 Participants |
| Skin phototype (Fitzpatrick scale) Type II | 3 Participants |
| Skin phototype (Fitzpatrick scale) Type III | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 0 / 12 | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 |
Outcome results
Primary
Blistering Time (First Vesicles)
Duration from the start of suction pressure to the development of first macroscopically visible vesicles (measured in minutes)
Time frame: Day 28±2, Day 56±2
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Intervention: Treatment With Petrolatum | Blistering Time (First Vesicles) | Blistering Time (First Vesicles) Day 28±2 | 43 Minutes |
| Intervention: Treatment With Petrolatum | Blistering Time (First Vesicles) | Blistering Time (First Vesicles) Day 56±2 | 47 Minutes |
| Control: No Treatment | Blistering Time (First Vesicles) | Blistering Time (First Vesicles) Day 28±2 | 39 Minutes |
| Control: No Treatment | Blistering Time (First Vesicles) | Blistering Time (First Vesicles) Day 56±2 | 27 Minutes |
Primary
Blistering Time (Full Blister)
Duration from the start of suction pressure to the development of a full blister (measured in minutes)
Time frame: Day 28±2, Day 56±2
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Intervention: Treatment With Petrolatum | Blistering Time (Full Blister) | Blistering Time (Full Blister) Day 28±2 | 63 Minutes |
| Intervention: Treatment With Petrolatum | Blistering Time (Full Blister) | Blistering Time (Full Blister) Day 56±2 | 65 Minutes |
| Control: No Treatment | Blistering Time (Full Blister) | Blistering Time (Full Blister) Day 28±2 | 54 Minutes |
| Control: No Treatment | Blistering Time (Full Blister) | Blistering Time (Full Blister) Day 56±2 | 62 Minutes |
Secondary
Epidermal Hydratation: Epidermal Moisture
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 %).
Time frame: Baseline, Day 14±1, Day 28±2, Day 42±2, Day 56±2
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Intervention: Treatment With Petrolatum | Epidermal Hydratation: Epidermal Moisture | Epidermal Moisture (%) Baseline | 47 percentage of tissue water |
| Intervention: Treatment With Petrolatum | Epidermal Hydratation: Epidermal Moisture | Epidermal Moisture (%) Day 28±2 | 43 percentage of tissue water |
| Intervention: Treatment With Petrolatum | Epidermal Hydratation: Epidermal Moisture | Epidermal Moisture (%) Day 56±2 | 47 percentage of tissue water |
| Intervention: Treatment With Petrolatum | Epidermal Hydratation: Epidermal Moisture | Epidermal Moisture (%) Day 42±2 | 46 percentage of tissue water |
| Intervention: Treatment With Petrolatum | Epidermal Hydratation: Epidermal Moisture | Epidermal Moisture (%) Day 14±1 | 46 percentage of tissue water |
| Control: No Treatment | Epidermal Hydratation: Epidermal Moisture | Epidermal Moisture (%) Day 42±2 | 42 percentage of tissue water |
| Control: No Treatment | Epidermal Hydratation: Epidermal Moisture | Epidermal Moisture (%) Baseline | 46 percentage of tissue water |
| Control: No Treatment | Epidermal Hydratation: Epidermal Moisture | Epidermal Moisture (%) Day 14±1 | 41 percentage of tissue water |
| Control: No Treatment | Epidermal Hydratation: Epidermal Moisture | Epidermal Moisture (%) Day 28±2 | 41 percentage of tissue water |
| Control: No Treatment | Epidermal Hydratation: Epidermal Moisture | Epidermal Moisture (%) Day 56±2 | 42 percentage of tissue water |
Secondary
Epidermal Hydratation: Stratum Corneum Hydration
Stratum corneum hydration (SCH) was measured with Corneometer® CM 825 (Courage & Khazaka electronic GmbH, Cologne, Germany) and expressed in arbitrary units (AU) (range 0-120 AU) on the volar forearm. Lower values represent reduced skin hydration in the upper skin layer.
Time frame: Baseline, Day 14±1, Day 28±2, Day 42±2, Day 56±2
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Intervention: Treatment With Petrolatum | Epidermal Hydratation: Stratum Corneum Hydration | Stratum corneum hydration (AU) Day 14±1 | 41 Arbitrary Units |
| Intervention: Treatment With Petrolatum | Epidermal Hydratation: Stratum Corneum Hydration | Stratum corneum hydration (AU) Day 42±2 | 38 Arbitrary Units |
| Intervention: Treatment With Petrolatum | Epidermal Hydratation: Stratum Corneum Hydration | Stratum corneum hydration (AU) Day 28±2 | 39 Arbitrary Units |
| Intervention: Treatment With Petrolatum | Epidermal Hydratation: Stratum Corneum Hydration | Stratum corneum hydration (AU) Day 56±2 | 41 Arbitrary Units |
| Intervention: Treatment With Petrolatum | Epidermal Hydratation: Stratum Corneum Hydration | Stratum corneum hydration (AU) Baseline | 43 Arbitrary Units |
| Control: No Treatment | Epidermal Hydratation: Stratum Corneum Hydration | Stratum corneum hydration (AU) Day 56±2 | 35 Arbitrary Units |
| Control: No Treatment | Epidermal Hydratation: Stratum Corneum Hydration | Stratum corneum hydration (AU) Baseline | 40 Arbitrary Units |
| Control: No Treatment | Epidermal Hydratation: Stratum Corneum Hydration | Stratum corneum hydration (AU) Day 14±1 | 36 Arbitrary Units |
| Control: No Treatment | Epidermal Hydratation: Stratum Corneum Hydration | Stratum corneum hydration (AU) Day 28±2 | 36 Arbitrary Units |
| Control: No Treatment | Epidermal Hydratation: Stratum Corneum Hydration | Stratum corneum hydration (AU) Day 42±2 | 36 Arbitrary Units |
Secondary
Epidermal Thickness
Optical coherence tomography (OCT) will be used to quantitatively measure changes of the epidermal thickness on the volar forearm
Time frame: Baseline, Day 28±2, Day 56±2
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Intervention: Treatment With Petrolatum | Epidermal Thickness | Epidermal Thickness (Baseline) | 78 micrometres (μm) |
| Intervention: Treatment With Petrolatum | Epidermal Thickness | Epidermal Thickness (Day 28±2) | 68 micrometres (μm) |
| Intervention: Treatment With Petrolatum | Epidermal Thickness | Epidermal Thickness (Day 56±2) | 75 micrometres (μm) |
| Control: No Treatment | Epidermal Thickness | Epidermal Thickness (Baseline) | 68 micrometres (μm) |
| Control: No Treatment | Epidermal Thickness | Epidermal Thickness (Day 28±2) | 72 micrometres (μm) |
| Control: No Treatment | Epidermal Thickness | Epidermal Thickness (Day 56±2) | 71 micrometres (μm) |