Effectiveness of a Combined Dermatological Treatment in Children With Atopic Dermatitis (KAOS)

July 5, 2019 updated by: Laboratorios Ordesa

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

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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

43

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Barcelona, Spain, 08022
        • Centro médico Quirón Teknon
    • Barcelona
      • Badalona, Barcelona, Spain, 08912
        • Centre Medic Digest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 5 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Combined dermatological treatment

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
Applied twice a day minimum.
Applied at libitum.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Sapena Jordi, MD, Centro médico Quirón Teknon
  • Principal Investigator: M.Carmen Gavilan, MD, Centro Digest Pediatric Badalona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2016

Primary Completion (Actual)

October 1, 2018

Study Completion (Actual)

October 1, 2018

Study Registration Dates

First Submitted

September 27, 2016

First Submitted That Met QC Criteria

September 28, 2016

First Posted (Estimate)

September 30, 2016

Study Record Updates

Last Update Posted (Actual)

July 9, 2019

Last Update Submitted That Met QC Criteria

July 5, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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