Effectiveness of a Combined Dermatological Treatment in Children With Atopic Dermatitis

Not Applicable

Completed

• Conditions: Atopic Dermatitis
• Interventions: Other: Pediatopic Treatment Cream; Other: Pediatopic Body lotion

• Registration Number: NCT02920411
• Lead Sponsor: Laboratorios Ordesa

Brief Summary

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

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).

Study Timeline

• Study First Submitted: 2016-09-27
• Study First Submitted QC: 2016-09-28
• Study First Posted: 2016-09-30
• Study Start: 2016-10
• Primary Completion: 2018-10
• Study Completion: 2018-10
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-05
• Last Update Posted: 2019-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Combined dermatological treatment	Pediatopic Treatment Cream	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
Combined dermatological treatment	Pediatopic Body lotion	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

Primary Outcome Measures

Name	Time	Method
Changes in Atopic Dermatitis severity according SCORAD test	At 15 days	\<16 mild; \>16\<40 moderate; \>40 severe

Secondary Outcome Measures

Name	Time	Method
Number of atopic dermatitis outbreaks	At 5 months	Number of episodes
Duration of stable periods (between outbreaks)	At 5 months	Register of days without outbreaks
Patient satisfaction assessed by Visual Analog Scales	At 5 months	Validated scale for patients \<5 years
Treatment compliance assessed by Morisky-Green test	At 5 months	Adherence / Compliance

Trial Locations

Locations (2)

Centre Medic Digest; 🇪🇸 Badalona, Barcelona, Spain

Centro médico Quirón Teknon; 🇪🇸 Barcelona, Spain