An exploratory randomized controlled trial to evaluate the effects of a leave-on product on the structural strength of the dermo epidermal junction and related molecular markers in elderly subjects with dry ski
- Conditions
- Dry skin
- Registration Number
- DRKS00031151
- Lead Sponsor
- Charité – Universitätsmedizin Berlin, Department of Dermatology, Venereology and Allergology, Clinical Research Center for Hair and Skin Science and the Institute of Clinical Nursing Science, Charité Center for Health and Human Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 12
•Aged healthy volunteers with dry skin in the skin area of interest (ODS categories 1 and/or 2)
•Sex: Male or Female
•65 to 85 years,
•Phototype I to III according to the Fitzpatrick classification,
•Body Mass Index between 20 and 30 kg/m2,
•Non-smoker of at least one year,
•Able to give written informed consent,
•Willing and able to fulfill the study requirements.
•ODS 3 or 4 in the skin area of interest,
•Unstable chronic condition (e.g. uncontrolled hypertension, heart disease),
•Known or suspected defect of healing,
•Tendency to keloid or hypertrophic scars,
•Diabetes mellitus,
•Hormone replacement therapy within last 3 months.
•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 atopic dermatitis, urticaria, psoriasis or scar on investigational areas,
•Tattoos in the skin area of interest,
•Any current skin malignancy,
•Any known allergies 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 4), (one NSAID 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,
•UV sessions or strong sun exposure of the arms during the study period,
•Current participation or participation within the last 4 weeks in another clinical trial,
•In the opinion of the investigator unlikely to comply with the clinical trial protocol.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Outcomes are strength of dermo-epidermal adhesion (the time it takes for the suction blister to form, in minutes), transepidermal water loss (TEWL), skin hydration (SCH), skin pH, surface topography and skin elasticity, epidermal thickness and skin dryness. In addition, the blister fluid and the blister skin will be analyzed in the laboratory for biomarkers of dry skin (interleukins; IL-1a, IL-6, IL-8) by ELISA.
- Secondary Outcome Measures
Name Time Method The study is based on an exploratory design. Neither primary nor secondary endpoints nor difference hypotheses were formulated.