Only healthy subjects
Conditions
Interventions
Group 1: Application of a cream containing ceramide NP C15:
50 subjects will be included in the study. The test products will be applied in a randomised half-side comparison (arms and legs). Both bef
Sponsors
IUF - Leibniz-Institut für umweltmed. Forschung GmbH
Eligibility
Sex/Gender
All
Age
20 Years to 50 Years
Inclusion criteria
Inclusion criteria: - Healthy with no clinically significant abnormality identified by medical history and clinical examination; - Healthy skin; - Must agree not to use cosmetic products from the beginning of the study at the screening visit and throughout the study in the tested areas; - Females capable of becoming pregnant must use contraception and must show a negative urine pregnancy test at V1; - Voluntary and active cooperation in the study; - Agreeing to follow the instructions of the investigator and to attend the centre at the agreed times; - Handwritten signature of the Informed Consent after the nature of the study has been fully explained; - Consent to confidential use and storage of all data for scientific purposes, as well as to the use of anonymised data for publication;
Exclusion criteria
Exclusion criteria: - Pregnant or lactating women; - Smoker; - Known allergy or intolerance (if possible documented in allergy pass card) to any component of the test preparations; - Use of sunbeds during the last three months or planned vacations for sunbathing during the study; - Medical history of skin cancer including Basal Cell Carcinoma (BCC); - Active skin diseases (e.g. psoriasis, eczema); - Individuals diagnosed with communicable diseases (e.g. hepatitis, Covid-19, monkeypox); - Immunosuppression due to medications (such as organ transplant recipient) or disease (including HIV or haematological malignancy); - Any systemic or topical medication, including herbal supplements, within 30 days prior to dosing, apart from paracetamol; - Scars, cuts, wounds, intensely tanned skin and dermal abnormalities in the test areas which may influence the result of the study; - Any use of oral nutritional supplementation three months before and during the study; - Member of high-risk group of hepatitis, HIV, and other infectious diseases; - Alcohol consumption of more than one unit of hard spirits/day; - Participation in a clinical research trial within 30 days prior to randomization;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Changes in the composition of the skin microbiota | — |
Secondary
| Measure | Time frame |
|---|---|
| - Changes in skin physiological measurements | — |
Countries
Germany
Contacts
Public ContactNatalie Aue
IUF - Leibniz-Institut für umweltmed. Forschung GmbH
Outcome results
None listed