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Completed

NCT Number: NCT02920411

Effectiveness of a Combined Dermatological Treatment in Children With Atopic Dermatitis

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.

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

1 month–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Medic Digest, Badalona, Barcelona, Spain

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pediatopic Treatment Cream

Other

Applied twice a day minimum.

Pediatopic Body lotion

Other

Applied at libitum.

Primary outcomes

  1. Changes in Atopic Dermatitis severity according SCORAD test

    Time frame: At 15 days

    <16 mild; >16<40 moderate; >40 severe

Secondary outcomes

  1. Number of atopic dermatitis outbreaks

    Time frame: At 5 months

    Number of episodes

  2. Duration of stable periods (between outbreaks)

    Time frame: At 5 months

    Register of days without outbreaks

  3. Patient satisfaction assessed by Visual Analog Scales

    Time frame: At 5 months

    Validated scale for patients <5 years

  4. Treatment compliance assessed by Morisky-Green test

    Time frame: At 5 months

    Adherence / Compliance

Sponsors and collaborators

Lead sponsor

Laboratorios Ordesa

Industry

Collaborators

  • Clever Instruments S.L.

Registry information

Official study title

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

Acronym: KAOS

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 30, 2016
Registry last updated
Jul 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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