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Completed

NCT Number: NCT01779258

Emollients in the Management of Atopic Dermatitis

The purpose of this study is to confirm that emollients play a major role in the maintenance therapy after clearing of inflammatory lesions and can reduce occurrence of flares in children with atopic dermatitis.

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Eczema Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

2 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Tallinn, Estonia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 2 and 6 years included,
  • Presenting with atopic dermatitis, with at least one duly documented flare treated by corticosteroids within the previous 6 months, and presenting a current flare (objective Scoring for Atopic Dermatitis (SCORAD score) is [15-40] at inclusion),
  • After treatment of the current flare, patients should have for randomization an Objective SCORAD score < 15, with Xerosis intensity≥ 1 and no subjective signs

Exclusion criteria

  • Severe form of atopic dermatitis requiring either systemic corticosteroid treatment and/or antibiotic or antiviral treatment and/or hospitalisation,
  • Primary bacterial, viral, fungal or parasitic skin infection,
  • Ulcerated lesions, acne or rosacea,
  • Dermatological disease other than atopic dermatitis which could interfere with the assessment,
  • Immunosuppression,

Treatment and study plan

glycerol, paraffin (liquid and white soft)

Drug

1 application in the morning and in the evening

Other names: Dexeryl®

Atopiclair®

Device

1 application in the morning, in the afternoon and in the evening

Locatop@

Drug

During the Run-In period:

1 application in the morning and in the evening during a maximum of 21 days

Locapred@

Drug

During the 3 months study treatment:

1 application in the evening in case of flare "

Primary outcomes

  1. Percentage of patients with at least one flare over the treatment period

    Time frame: 12 weeks of treatment.

    A flare is defined as following: measurable increased extend or intensity of lesions in less than 2 weeks under continued treatment corresponding to a significant increase in medical score (> 25%) or to the introduction of a new line of therapy(topical corticosteroid).

Sponsors and collaborators

Lead sponsor

Pierre Fabre Medicament

Industry

Registry information

Official study title

Emollients in the Management of Atopic Dermatitis in Children: Prevention of Flares.

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 30, 2013
Registry last updated
Feb 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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