- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02920411
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
Status
Completed
Conditions
Intervention / Treatment
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
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-
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Barcelona, Spain, 08022
- Centro médico Quirón Teknon
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Barcelona
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Badalona, Barcelona, Spain, 08912
- Centre Medic Digest
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-
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:
|
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
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At 5 months
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Patient satisfaction assessed by Visual Analog Scales
Time Frame: At 5 months
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Validated scale for patients <5 years
|
At 5 months
|
Treatment compliance assessed by Morisky-Green test
Time Frame: At 5 months
|
Adherence / Compliance
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At 5 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- KAOS-02-16
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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