Effect of a Basic Skin Care Product on the Structural Strength of the Skin (NCT03625167) | Clinical Trial Compass
CompletedNot Applicable
Effect of a Basic Skin Care Product on the Structural Strength of the Skin
Germany17 participantsStarted 2018-07-31
Plain-language 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.
Who can participate
Age range65 Years – 85 Years
SexFEMALE
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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-inflamma…