Effectiveness of a Combined Dermatological Treatment in Children With Atopic Dermatitis

Atopic Dermatitis Clinical Trial

— KAOS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02920411
• Other study ID #: KAOS-02-16
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: October 2018

Study information

• Verified date: July 2019
• Source: Laboratorios Ordesa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Other:
• Pediatopic Treatment Cream
Applied twice a day minimum.
• Pediatopic Body lotion
Applied at libitum.

Locations

Country	Name	City	State
Spain	Centre Medic Digest	Badalona	Barcelona
Spain	Centro médico Quirón Teknon	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Laboratorios Ordesa	Clever Instruments S.L.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Atopic Dermatitis severity according SCORAD test	<16 mild; >16<40 moderate; >40 severe	At 15 days
Secondary	Number of atopic dermatitis outbreaks	Number of episodes	At 5 months
Secondary	Duration of stable periods (between outbreaks)	Register of days without outbreaks	At 5 months
Secondary	Patient satisfaction assessed by Visual Analog Scales	Validated scale for patients <5 years	At 5 months
Secondary	Treatment compliance assessed by Morisky-Green test	Adherence / Compliance	At 5 months