Effectiveness of a Combined Dermatological Treatment in Children With Atopic Dermatitis

NCT ID: NCT02920411

Last Updated: 2019-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2018-10-31

Brief Summary

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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

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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).

Conditions

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Atopic Dermatitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Pediatopic Treatment Cream

Intervention Type OTHER

Applied twice a day minimum.

Pediatopic Body lotion

Intervention Type OTHER

Applied at libitum.

Interventions

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Pediatopic Treatment Cream

Applied twice a day minimum.

Intervention Type OTHER

Pediatopic Body lotion

Applied at libitum.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

1 Month

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clever Instruments S.L.

INDUSTRY

Sponsor Role collaborator

Laboratorios Ordesa

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sapena Jordi, MD

Role: PRINCIPAL_INVESTIGATOR

Centro Médico Quirón Teknon

M.Carmen Gavilan, MD

Role: PRINCIPAL_INVESTIGATOR

Centro Digest Pediatric Badalona

Locations

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Centre Medic Digest

Badalona, Barcelona, Spain

Site Status

Centro médico Quirón Teknon

Barcelona, , Spain

Site Status

Countries

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Spain

Other Identifiers

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KAOS-02-16

Identifier Type: -

Identifier Source: org_study_id

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