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

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Pediatopic Treatment Cream
Pediatopic Body lotion
Sponsored by
Laboratorios Ordesa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis

Eligibility Criteria

1 Month - 5 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Medic Digest
  • Centro médico Quirón Teknon

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Combined dermatological treatment

Arm Description

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

Outcomes

Primary Outcome Measures

Changes in Atopic Dermatitis severity according SCORAD test
<16 mild; >16<40 moderate; >40 severe

Secondary Outcome Measures

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

Full Information

First Posted
September 27, 2016
Last Updated
July 5, 2019
Sponsor
Laboratorios Ordesa
Collaborators
Clever Instruments S.L.
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1. Study Identification

Unique Protocol Identification Number
NCT02920411
Brief Title
Effectiveness of a Combined Dermatological Treatment in Children With Atopic Dermatitis
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
October 2016 (Actual)
Primary Completion Date
October 2018 (Actual)
Study Completion Date
October 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratorios Ordesa
Collaborators
Clever Instruments S.L.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Combined dermatological treatment
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Pediatopic Treatment Cream
Intervention Description
Applied twice a day minimum.
Intervention Type
Other
Intervention Name(s)
Pediatopic Body lotion
Intervention Description
Applied at libitum.
Primary Outcome Measure Information:
Title
Changes in Atopic Dermatitis severity according SCORAD test
Description
<16 mild; >16<40 moderate; >40 severe
Time Frame
At 15 days
Secondary Outcome Measure Information:
Title
Number of atopic dermatitis outbreaks
Description
Number of episodes
Time Frame
At 5 months
Title
Duration of stable periods (between outbreaks)
Description
Register of days without outbreaks
Time Frame
At 5 months
Title
Patient satisfaction assessed by Visual Analog Scales
Description
Validated scale for patients <5 years
Time Frame
At 5 months
Title
Treatment compliance assessed by Morisky-Green test
Description
Adherence / Compliance
Time Frame
At 5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sapena Jordi, MD
Organizational Affiliation
Centro Médico Quirón Teknon
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
M.Carmen Gavilan, MD
Organizational Affiliation
Centro Digest Pediatric Badalona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Medic Digest
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08912
Country
Spain
Facility Name
Centro médico Quirón Teknon
City
Barcelona
ZIP/Postal Code
08022
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effectiveness of a Combined Dermatological Treatment in Children With Atopic Dermatitis

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