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 |
|---|---|
| Clever Instruments S.L. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine the effectiveness of a combined dermatological treatment in children up to 5 years old with mild or moderated atopic dermatitis.
The intensive cream and body lotion of the PediATOPIC® products are two emollients expressly formulated to serve as adjuvants in the management of Atopic Dermatitis. Both products contain Dermosense complex®, a complex that includes 3 products: Bodyfensine peptide® (inductor of dephensine synthesis against microbial aggressions), Unimoist® (the mimetizing complex of the skin's natural hydration factor), and Ramnosoft® (polysaccharide that inhibits the adhesion of pro-inflammatory drugs and bacteria, while limiting the spread of inflammatory reactions in skin cells). They also contain Bisabolol, (plant extract with anti-inflammatory, anti-irritant and antimicrobial properties) and Panthenol (Pro vitamin B5 that accelerates the skin's natural regeneration process).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combined dermatological treatment | Experimental | A combined treatment of two emollient products will be applied:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pediatopic Treatment Cream | Other | Applied twice a day minimum. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Atopic Dermatitis severity according SCORAD test | <16 mild; >16<40 moderate; >40 severe | At 15 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of atopic dermatitis outbreaks | Number of episodes | At 5 months |
| Duration of stable periods (between outbreaks) | Register of days without outbreaks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sapena Jordi, MD | Centro Médico Quirón Teknon | Principal Investigator |
| M.Carmen Gavilan, MD | Centro Digest Pediatric Badalona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Medic Digest | Badalona | Barcelona | 08912 | Spain | ||
| Centro médico Quirón Teknon |
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
Not provided
| Pediatopic Body lotion |
| Other |
Applied at libitum. |
|
| At 5 months |
| Patient satisfaction assessed by Visual Analog Scales | Validated scale for patients <5 years | At 5 months |
| Treatment compliance assessed by Morisky-Green test | Adherence / Compliance | At 5 months |
| Barcelona |
| 08022 |
| Spain |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |