Atopic dermatitis Skin and Connective Tissue Diseases Atopic dermatitis
Conditions
Interventions
Subjects aged between 18 and 50 years showing a mild-moderate score of atopic dermatitis (AD) diagnosed by SCORAD, will be equally randomized in two groups to receive one capsule/day of food supplemen
Sponsors
Complife Italia Srl
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18-50 years, with Phototype I to IV 2. Mild to moderate SCORAD (between 15 and 25) 3. Willingness to use during all the study period only the products to be tested 4. Subjects who have not been recently involved in any other similar study 5. Willingness to not use products likely to interfere with the products to be tested 6. Willingness to not vary the normal daily routine (i.e. lifestyle, physical activity, etc.)
Exclusion criteria
Exclusion criteria: 1. Current antibiotic administration 2. Known history of chronic medical condition such as congenital heart disease, liver or kidney disease, or immune deficiency 3. Treatment with probiotics in the 6 months preceding enrollment 4. Treatment with steroids and antihistamines systemically in the three months prior to enrollment 5. Topical treatments with immunomodulators (tacrolimus or pimecrolimus) in the three months prior to enrollment 6. Acute or chronic infectious diseases 7. Subjects who has used sun-beds or self-tanning product for one month before the study or intend to use it during the present study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Clinical assessment of the SCORAD Index evaluated by a dermatologist at the beginning of the study (T0d), throughout the intake of the products (T28d and T56d) and 4 weeks after the intake of the products (T84d) 2. Clinical assessment of Skin smoothness evaluated by a dermatologist at the beginning of the study (T0d), throughout the intake of the products (T28d and T56d) and 4 weeks after the intake of the products (T84d) 3. Determination of the Skin moisturization evaluated as Skin Moisturization Index (Corneometer method) and Trans Epidermal Water Loss (TEWL) at the beginning of the study (T0d), throughout the intake of the products (T28d and T56d) and 4 weeks after the intake of the products (T84d) 4. Cytokine expression such as TNFa (general), TARC (Thymus and activated-regulated chemokine) and TSLP (Thymic Stromal Lymphopoietin) measured by ELISA on skin tape stripping sampled at the beginning of the study (T0d) and throughout the intake of the products (T28d and T56d) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Relief from skin discomfort evaluated using a self-assessment questionnaire administered at the end of treatment (T56d) and after the follow-up period (T84d) 2. Quality of life evaluated using a self-assessment questionnaire administered at the end of treatment (T56d) and after the follow-up period (T84d) | — |
Countries
Italy
Outcome results
None listed