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

Laboratorios Ordesa

Status: Completed

Conditions: Atopic Dermatitis

Treatments: Other: Pediatopic Treatment Cream; Other: Pediatopic Body lotion

Study type: Interventional

Funder types: Industry

Identifiers

NCT02920411

KAOS-02-16

Details and patient eligibility

About

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.

Full 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).

Enrollment: 43 patients

Sex: All

Ages: 1 month to 5 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

43 participants in 1 patient group

Combined dermatological treatment

Experimental group

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

Treatment:

Other: Pediatopic Treatment Cream

Other: Pediatopic Body lotion