Suction blister study to investigate the influence of a collagen peptide-containing nutritional supplement (ELASTEN®) on collagen synthesis after 12 weeks of ingestion - Pilot study
- Conditions
- Healthy, aged skin
- Registration Number
- DRKS00034161
- Lead Sponsor
- QUIRIS Healthcare GmbH & Co. KG
- Brief Summary
Overall, the study results show a relevant and statistically significant increase in the consolidation and strengthening of the skin collagen network as well as an increase in the skin hyaluronic acid concentration of the volunteers after 12 weeks of supplementation with collagen peptides. Using a novel method, it could be shown that a targeted dietary supplement can significantly restore the microstructural integrity of the dermal collagen network, which is disrupted by skin aging processes. The results not only confirm the existing data on the beneficial effects of oral collagen peptides on skin structure and function, but also extend previous findings from experimental studies and randomised, placebo-controlled clinical trials on the ultrastructural morphological level of the skin collagen network and hyaluronic acid content exerted by the investigational supplement
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 9
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
•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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To investigate the influence of the nutritional supplement ELASTEN® drinking ampoules on the collagen synthesis of the skin using the suction blister method.
- Secondary Outcome Measures
Name Time Method To investigate the influence of the nutritional supplement ELASTEN® drinking ampoules on the hyaluronic acid in the skin using the suction blister method.