Randomized, placebo-controlled, blindtrial to evaluate tolerability and impact on skin hydration, skin density, skin roughness and skin elasticity of ELASTEN®, a dietary supplement containing special collagen peptides, compared to placebo (without nutritive substances), including 72 female volunteers with healthy skin aged 35 years or older
Not Applicable
- Conditions
- healthy volunteers
- Registration Number
- DRKS00015664
- Lead Sponsor
- QUIRIS Healthcare GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 72
Inclusion Criteria
(1) skin type: any, (2) Written informed consent of volunteers or legal guardian available, (3) Volunteers must be able to communicate with the investigator and to understand and follow requirement of the clinical trial
Exclusion Criteria
(1) Severe or chronic skin inflammation, (2) Severe internal or chronic diseases, (3) Intake of drugs which can impair the skin reaction (e.g. glucocorticoids, antiallergics, immunomodulators), (4) Application of preparations or care products containing an active substance 7-10 days before study onset, (5) Severe allergies or ever occured serious adverse effects by cosmetic preparations, (6) Sunbathing or solarium visits during the study, (7) Pregnancy or lactation.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of tolerability: Assessment of skin reactions and possible other adverse effects in the questionnaire, from study onset up to 30 days after study end
- Secondary Outcome Measures
Name Time Method Evaluation of efficacy (at T0, T12 and T16): - Skin hydration (corneometry, forearm) - Skin elasticity (Cutometer, forearm) - Skin roughness (PRIMOS replicas, face) - Skin density (sonographic measurements, thigh)