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 |
|---|---|
| Bioithas SL | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
The goal of this study is to evaluate the efficacy of the emollient topical formulation containing Lactobacillus reuteri in improving atopic dermatitis symptoms in children.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic Ointment | Experimental | Twice-daily application for 8 weeks of an emollient topical formulation containing Lactobacillus reuteri |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic Ointment | Other | Ointment containing Lactobacillus reuteri |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in SCORing Atopic Dermatitis (SCORAD) after 8 weeks | Change in SCORing Atopic Dermatitis (SCORAD) index from baseline after 8 weeks of treatment with the topical emollient formulation containing Lactobacillus reuteri | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in SCORing Atopic Dermatitis (SCORAD) after 1 week | Change in SCORing Atopic Dermatitis (SCORAD) index from baseline after 1 week of treatment with the topical emollient formulation containing Lactobacillus reuteri | 1 week |
| Change in SCORing Atopic Dermatitis (SCORAD) after 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Microbiota composition | Comparative analysis of alpha and beta diversity and overall composition of the skin microbiota using high throughput 16S rRNA gene sequencing on skin swabs collected at baseline and at the end of the study. | Baseline and 8 weeks |
| Microbiota composition |
Inclusion Criteria:
Pediatric patients of both sexes, aged between 6 months and 12 years, with a confirmed diagnosis of AD based on Hanifin and Rajka criteria (ANNEX VIII).
SCORAD index between 20 and 50, inclusive.
Signed informed consent by parents or legal guardians.
Exclusion Criteria:
History of phototherapy for the treatment of AD.
Previous treatment with biologic agents or JAK inhibitors for AD.
Use of systemic corticosteroids within one month prior to inclusion in the clinical trial.
Use of topical corticosteroids within one month prior to inclusion in the clinical trial.
Use of conventional systemic immunosuppressants for AD (e.g., azathioprine, methotrexate, or cyclosporine) within three months prior to inclusion in the clinical trial.
Use of oral or topical probiotics within two months prior to inclusion in the clinical trial.
Use of topical or systemic antibiotics within one month prior to inclusion in the clinical trial.
Known hypersensitivity to the investigational product or any of its components.
Underlying immune-mediated diseases requiring systemic corticosteroid therapy.
Active infection in areas affected by AD requiring antibiotic, antifungal, or antiviral treatment within the one month prior to inclusion in the clinical trial.
Fever at the start of treatment (axillary temperature >37.5 °C or equivalent).
Diagnosed immunodeficiency disorders.
Current or past diagnosis of malignant neoplasms.
Any concurrent dermatologic or medical condition that, in the investigator's opinion, could interfere with the subject's response to treatment or require continuous use of topical corticosteroids.
Participation in other clinical research studies involving investigational products within one month prior to inclusion in the clinical trial.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Belaneve Clinics | Alicante | Spain | ||||
| Centro Dermatológico Estético Alicante |
Not provided
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D004485 | Eczema |
| 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
Not provided
Change in SCORing Atopic Dermatitis (SCORAD) index from baseline after 4 weeks of treatment with the topical emollient formulation containing Lactobacillus reuteri |
| 4 weeks |
| Change in POEM | Change in POEM score from baseline after 1, 4, and 8 weeks of treatment with the topical emollient formulation containing Lactobacillus reuteri | 1, 4 and 8 weeks |
| Change in PIQoL-AD | Change in PIQoL-AD score from baseline after 8 weeks of treatment with the topical emollient formulation containing Lactobacillus reuteri | 8 weeks |
Comparative analysis of total bacterial load and Staphylococcus aureus load by qPCR on skin swabs collected at baseline and at the end of the study. |
| Baseline and 8 weeks |
| Adverse Events | Incidence and severity of all adverse events. | 8 weeks |
| Alicante |
| Spain |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |