Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Zurko Research | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
This study evaluates the tolerability and efficacy of a probiotic ointment compared with a comparator lotion in children with atopic dermatitis.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic Ointment | Experimental | Probiotic Ointment 2x day |
|
| Comparator Product | Experimental | Comparator product 2x day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic Ointment | Other | Probiotic ointment |
| |
| Comparator product |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Endpoint | To evaluate the change in SCORAD from baseline to Day 28. | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Endpoint | To evaluate the change in SCORAD from baseline to Day 14 | 14 days |
| Secondary Endpoint | To evaluate the change in local SCORAD from baseline to Day 14 and Day 28 |
Not provided
Inclusion Criteria Male and female pediatric patients aged 0.5 years to 15 years with Atopic Dermatitis.
SCORAD Index at D0 = 15 to 50, inclusive. In goodgeneral health as reported by the parent(s)/legal representative(s). Available for the full duration of the study and willing to comply with procedures.
Subjects whose parents or legal representative are willing to sign the informed consent.
Exclusion Criteria Use of phototherapy for atopic dermatitis. Use of systemic corticosteroids within 2 weeks prior to the study. Use of Immunosuppressive or cytostatic drugs within 1 months prior to the study.
Use of antibiotics (topical and systemic) within 15 days prior to the start of the study.
Subjects who are treated with vitamin A-derived compounds or other topical medications for acne in the experimental area during the 30 days prior to the start of the study.
History of sensitivity to the study products, or its components. History or evidence of allergies requiring acute or chronic treatment (except seasonal allergic rhinitis).
Subjects with active infection in atopic dermatitis areas requiring antibiotics, antifungals, or antiviral agents within 7 days before baseline participation in any study that would interfere with the current study.
Fever (temperature> 37.5 °C axillary or equivalent) during 48 hours prior the start of the study.
Pathologies associated with immunodeficiency or cancer processes. Any concurrent dermatologic or medical conditions that may interfere with the investigators ability to assess the subject's response to the study drug or require the continued use of topical corticosteroids.
Subjects who have received the schedule MMR vaccination during the study period or have received the last dose within three weeks prior the start of the study.
Subjects who participates in any study that would interfere with the current study.
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sofia Nordh, PhD | Contact | +46 (0)8 555 293 00 | son@biogaianewsciences.com |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Other |
Basic lotion |
|
| 14 and 28 days |
| Secondary Endpoint | To evaluate the change in skin barrier function (TEWL) from baseline to Day 14 and Day 28 | 14 and 28 days |
| Secondary Endpoint | To evaluate the change in POEM score from baseline to Day 14 and Day 28 | 14 and 28 days |
| Secondary endpoint | To evaluate the change in itch NRS from baseline to Day 14 and Day 28 | 14 and 28 days |
| Secondary Endpoint | To evaluate the use of topical corticosteroids during the study period | 28 days |
| Secondary Endpoint | To explore changes in skin microbiota between baseline and Day 28 | 28 Days |
| Secondary Endpoint | To evaluate patient-reported tolerability and reported adverse events during the study period | 28 days |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |