Atopic dermatitis Skin and Connective Tissue Diseases Atopic dermatitis
Conditions
Interventions
A restricted randomisation list was created using PASS 11 (version 11.0.8
PASS, LLC. Kaysville, UT, USA) statistical software running on Windows Server 2008 R2 Standard SP1 64-bit edition (Microsoft, USA) by a biostatistician and stored in a safe place. Randomisation sequen
Sponsors
IBSA Farmaceutici (Italy)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female subjects, aged 18 years or older at the screening visit 2. Caucasian ethnicity 3. Subjects with a diagnosis of AD for at least 6 months prior to Day 1 visit 4. Subjects with basal SCORAD between 25 and 40 5. Adequate rest period between two similar studies 6. Willingness to not use products likely to interfere with the product to be tested 7. Willingness to not use, during all the study period, face creams other than the products supplied 8. Subject of childbearing potential is under effective contraception (oral/not oral); not expected to be changed during the study period 9. Subject informed about the study procedures and having signed an informed consent form
Exclusion criteria
Exclusion criteria: 1. Subject does not meet the inclusion criteria above 2. Pregnant or breastfeeding women 3. Subject with a history of any confounding inflammatory skin diseases or any other skin disease, e.g., psoriasis, rosacea, erythroderma or ichthyosis, that could interfere with the evaluation of AD 4. Subject with spontaneously improving or rapidly deteriorating AD 5. Subject with active allergic contact dermatitis or other non-atopic forms of dermatitis 6. Subject with acute infections 7. Use within 4 weeks prior to baseline (Day 1) of oral or intravenous corticosteroids, 8. UVA/UVB therapy, PUVA (psoralen plus ultraviolet A) therapy, tanning booths, non-prescription UV light sources, immunomodulators or immunosuppressive therapies, 9. interferon, or cytotoxic drugs 8. Use within 1 week prior to baseline (Day 1) of antihistamines, topical antibiotics, topical corticosteroids, topical calcineurin inhibitors or other topical drug products used for treating AD 9. Use within 24 hours prior to baseline (Day 1) of any topical product (e.g., sunscreens, lotions, creams) in the areas to be treated
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Atopic dermatitis severity assessed using SCORAD questionnaire at baseline and after 7, 14, 28 days of treatment 2. Atopic dermatitis signs of amelioration assessed by the participants using POEM questionnaire at baseline and after 7, 14, 28 days of treatment 3. Itching sensation measured using a 0-10 visual analogical scale (VAS) at baseline, immediately after product application and after 0.5 and 1 hour from product application | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Skin moisturization measured using Corneometer® CM 825 (Courage + Khazaka electronic GmbH) at baseline, 1 hour after product application, and after 7, 14, 28 days of treatment 2. Transepidermal water loss (TEWL) measured using Tewameter® TM 300 (Courage + Khazaka electronic GmbH) at baseline, 1 hour after product application, and after 7, 14, 28 days of treatment | — |
Countries
Italy
Outcome results
None listed