Effectiveness of a Combined Dermatological Treatment in Children With Atopic Dermatitis

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02920411

Acronym

KAOS

Enrollment

Registered

2016-09-30

Start date

2016-10-31

Completion date

2018-10-31

Last updated

2019-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis

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).

Interventions

OTHERPediatopic Treatment Cream

Applied twice a day minimum.

OTHERPediatopic Body lotion

Applied at libitum.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Months to 5 Years

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

Design outcomes

Primary

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

Secondary

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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026