L20.9
Conditions
Interventions
Group 1: Application of Bepanthen® SensiDaily once daily on forearms and lower legs and twice daily, on the rest of the body once daily
Group 2: Application of Basiscreme DAC once daily on forearms an
Sponsors
Charité Campus Charité Mitte
Eligibility
Sex/Gender
All
Age
2 Years to 65 Years
Inclusion criteria
Inclusion criteria: - Male or female sex, aged between 2 and 12 years or between 18 and 65 years at inclusion - Signed informed consent by the adult and children 6-12 years old. For 6-12 years old as well as younger children, parent(s) or guardian(s) have to give their written informed consent for their child’s participation in the study. - Diagnosis of AD according to the criteria of Hanifin and Rajka - Mild severity of the atopic dermatitis, defined as an Eczema Area and Severity Index (EASI) < 7 (Leshem et al. 2015) - Subject with a general good and stable health condition as confirmed by medical history and by a physical examination. - Subjects with clinically stable medical conditions, e.g. adequately treated hypertension, diabetes mellitus type II, hypercholesterolemia, osteoarthritis can be included in the study, if the medication taken for the treatment of the disease does not match the criteria of the excluded or disallowed medications. - Accept to abstain from intensive and direct sun exposure and solarium during the study. - Agree to use the same skin cleaning procedures during the study, including products for bathing/showering. - Are free of any dermatological condition or skin affection, which may interfere with the study assessments, e.g. scars or other lesions at the investigational sites.
Exclusion criteria
Exclusion criteria: - Subjects, parent(s) or guardians who are unable to understand the subject’s information, e.g. for linguistic or psychiatric reasons, and to give their consent. - Subjects, parent(s) or guardian(s) who have forfeited their freedom by administrative or legal decision or under guardianship. - Subjects, parent(s), guardian(s) unable to comply with study-related constraints. - Subject currently participating in or in the exclusion period of another study. Criteria related to diseases - Any dermatological condition or skin affection which may interfere with the study assessments, e.g. scars or other lesions at the investigational sites - Clinically significant, possibly unstable medical conditions such as metastatic tumor or tumor with high probability of metastatic spread, cardiovascular, immunosuppressive, hematologic, hepatic, renal, neurologic, endocrine, collagen-vascular, gastrointestinal diseases. - Currently having malignant or benign tumors of the skin in the investigational area. - Any other acute or chronic pathology that may interfere with the study conduct in the investigator’s opinion. - Known allergy or intolerance to any ingredients of the study products Criteria related to treatments and products - Current topical or systemic treatment affecting the skin, e.g. diuretics, cholesterol-lowering drugs, hormones etc. - Treatment of dry and/or inflammatory skin conditions with topical corticosteroids within 2 weeks before inclusion. - Treatment with topical immunosuppressants, antibiotics, retinoids, antiseptics or antihistaminic drugs within 2 weeks before inclusion - Systemic immunosuppressive or immunomodulatory therapy, antibody treatment (e.g dupilumab), antibiotics or probiotics within 4 weeks before inclusion. - Therapeutic UV-Radiation within 6 weeks before inclusion. - Increased UV-exposure within 6 weeks before inclusion. - Use of any leave-on skin product within 48 hours before inclusion/baseline visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference of microbiological diversity, estimated by calculating Shannon’s diversity index on the left volar forearm after three and six months between groups | — |
Secondary
| Measure | Time frame |
|---|---|
| - Difference of skin microbiological diversity, estimated by calculating Shannon’s diversity index on the left lower lateral leg after three and six months between groups. Evaluation will be carried out by microbiome analysis (Next Generation Sequencing, NGS). - Differences of spatial distribution and quantity of specific populations at the left volar forearm and lower lateral leg at Visits 3 and 5 between groups. Evaluation will be carried out by fluorescence in situ hybridization (FISH) on selected samples taken for skin microbiological diversity. Decision on the selection of samples will be based on the microbiome results (primary outcome). - Differences of transepidermal water loss (TEWL) in g/m2/h at the left volar forearm and lower lateral leg after three and six months between groups. - Differences of skin surface pH at the left volar forearm and lower lateral leg after three and six months between group. - Differences of stratum corneum hydration (SCH) at the left volar forearm and lower lateral leg after three and six months between groups. - Differences between EASI Scores after three and six months between groups. | — |
Countries
Germany
Contacts
Public ContactKathrin Hillmann
Charité – Universitätsmedizin BerlinDept. for Dermatology, Venereology and AllergologyClinical Research Center for Hair and Skin Science
Outcome results
None listed