Healthy, aged skin
Conditions
Interventions
Group 1: Heathy females at the age of 35 – 65 years
generation of 3 suction blisters before the first intake of the test product and after 12 weeks of
regular, once-daily intake of the test product.
Sponsors
QUIRIS Healthcare GmbH & Co. KG
Eligibility
Sex/Gender
Female
Age
35 Years to 65 Years
Inclusion criteria
Inclusion criteria: - Generally healthy female - Fitzpatrick-Phototype I – III, Caucasian - All skin types allowed - In general, good health and mental condition - Willing and able to sign the informed consent - Willing and capable to follow the study rules and a fixed schedule - Healthy skin in the test area
Exclusion criteria
Exclusion criteria: • Deviation from any of the above-mentioned inclusion criteria • Subjects taking nutritional supplements within a period of 12 weeks prior to this study • Subjects additionally taking other nutritional supplements within the study period of 12 weeks • Subjects where the majority of suction blisters fail to develop will be excluded from the study (minimum of blister fluid per subject: 50µl) • Gastrointestinal disease and/or digestive disorders • Subjects who are pregnant, lactating or have given birth within the previous 3 months or are planning to be pregnant, during the study, no reliable contraception • Subjects who are undergoing menopause • Visual indication of blood vessel trauma or coagulopathy • Acute and/or chronic skin diseases (e.g. atopic eczema, neurodermatitis, psoriasis), moles, tattoos, strong pigmentation at the test area or scars in the test area • Damaged skin (sunburn, rash, cuts, open wounds, burns, active infections, inflammation) in the test area • History of keloids and hypertrophic scars • Many hairs in the test area • Known incompatibilities against the plaster (sensitive plaster “Hansaplast Schnelle Heilung”) or against ingredients of the test product (e.g., collagen, fructose) • Topical medication in the test area within 1 month prior to study start • Physical and/or cosmetic treatment (massage, peeling) at the test area within 1 month prior to study start • Systemic medication with anti-inflammatory agents (e.g. acetylsalicylic acid, ibuprofen) within 2 weeks prior to study start • Systemic medication with immunosuppressants (e.g. corticoids), antibiotics, anticoagulant (e.g. Marcumar®) and/or retinoids within 4 weeks prior to study start • Intake of any medication which could interfere in the opinion of the principal investigator and/or the medical director with the study aim • Systemic illness of the subject at the beginning of the study • Immunological disorders, e.g. HIV, infectious hepatitis • Severe disorders within the last 6 month, e.g. acute cardiac- and circularity disorders, serious diabetics • Connective tissue diseases • Severe illness on account of which the subject should not participate in the study in the opinion of the principle investigator and/or the medical director • Skin tumours or malignant disease or a history of those within the last 10 years • Disorders within the last 7 days before starting the study with a fever period of more than 24 h • Participation in other studies on the forearms during the last 2 weeks or simultaneously • Participating in a study with a pharmaceutical preparation within a period of at least 4 weeks prior to this study • Alcohol and drug abuse • Change in diet or lifestyle habits (e.g. sports, smoking) and/or start or change of oral hormonal treatment or oral contraception within a period of 12 weeks prior to this study • Extreme sports, heavy physical work, sauna, swimming on the day before suction blister generation (visit 1 and 3) • Exposition of the test area to UV-radiation with at least a slight sunburn within 4 weeks prior to study start • Treatment with leave on products at the test area within 7 days prior to study start • Lack of compliance, unable or unwilling to cooperate or complete the study • Inadequate language proficiency (spoken and written) • Psychiatric conditions that might limit the participation in the study and/or that lead to the assumption that the ability to complet
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To investigate the influence of the nutritional supplement ELASTEN® drinking ampoules on the collagen synthesis of the skin using the suction blister method. | — |
Secondary
| Measure | Time frame |
|---|---|
| To investigate the influence of the nutritional supplement ELASTEN® drinking ampoules on the hyaluronic acid in the skin using the suction blister method. | — |
Countries
Germany
Contacts
Public ContactDörte Segger
SGS Institut Fresenius GmbH
Outcome results
None listed