Effectiveness of a Combined Dermatological Treatment in Children With Atopic Dermatitis

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Estudio Piloto Sobre la Efectividad de la acción Conjunta de Una Crema Corporal y un bálsamo Corporal en niños Con Dermatitis atópica

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Other: Pediatopic Treatment Cream
* Other: Pediatopic Body lotion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children from 1 month to 5 years old Patients with atopic dermatitis mild-moderate with an SCORAD=16-40 Exclusion Criteria: Other dermatological diseases that could interfere with the study results Corticoids use during 3 weeks prior to the study Antibiotics use to treat atopic dermatitis during 3 weeks prior to the study Use of topical immunomodulators Concurrent use of other emollients

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combined dermatological treatment<br>A combined treatment of two emollient products will be applied: Pediatopic treatment cream during acute stages of atopic dermatitis and Pediatopic body lotion during stable stages | Other: Pediatopic Treatment Cream<br>* Applied twice a day minimum.<br>Other: Pediatopic Body lotion<br>* Applied at libitum.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Atopic Dermatitis severity according SCORAD test | <16 mild; >16<40 moderate; >40 severe | At 15 days | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |