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This exploratory study aims to evaluate the impact of a cosmetic product (Lactibiane Topic AD) vs placebo on skin flora and skin reinforcement barrier in mild to moderate atopic dermatitis using biometrological, biological and clinical parameters.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lactibiane topic AD | Experimental | Cosmetical product Lactibiane Topic AD |
|
| Placebo | Placebo Comparator | Placebo made with the same base as the cosmetical product |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactibiane Topic AD | Other | Application of Lactibiane topic AD twice a day (morning and evening) on one lesional area |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in skin flora composition | 16S rRNA sequencing, qPCR | from baseline (Day 0) at Day 21 |
| Change in skin flora composition | 16S rRNA sequencing, qPCR | from baseline (Day 0) at Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Skin barrier status | TransEpidermal Water Loss (TEWL) | Day 0, Day 14, Day 21 |
| Patient Oriented SCORing Atopic Dermatitis | Patient Oriented SCORing Atopic Dermatitis (POSCORAD): 0 - 103 (Higher values represent a worse outcome) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unité de Recherche Clinique en Immunologie - Lyon Sud | Pierre-Bénite | 69495 | France |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| Placebo | Other | Application of placebo twice a day (morning and evening) on the symmetrical lesional area |
|
| Day 0, Day 14, Day 21 |
| SCORing Atopic Dermatitis | SCORing Atopic Dermatitis (SCORAD) : 0 - 103 (Higher values represent a worse outcome) | Day 0, Day 14, Day 21 |
| Clinical severity of lesional areas | Scoring of lesional area by subject and investigator : 0-18 (Higher values represent a worse outcome) | Day 0, Day 14, Day 21 |
| Manifestation of adverse local reactions | Subjects will use a diary to document any potential adverse reactions observed after product application | From Day 0 to Day 21 |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |