Emollients in the Management of Atopic Dermatitis

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01779258
• Other study ID #: V00034 CR 3 13 1B
• Secondary ID: 2012-004621-24
• Status: Completed
• Phase: Phase 3
• First received: January 28, 2013
• Last updated: February 18, 2014
• Start date: February 2013
• Est. completion date: February 2014

Study information

• Verified date: February 2014
• Source: Pierre Fabre Medicament
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: Comité de Protection des PersonnesRomania: Ethics CommitteeRomania: National Agency for Medicines and Medical DevicesLithuania: State Medicine Control Agency - Ministry of HealthLithuania: Bioethics CommitteePoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsPoland: Ethics CommitteeEstonia: The State Agency of MedicineEstonia: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 347
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 6 Years

Eligibility

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,

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• glycerol, paraffin (liquid and white soft)
1 application in the morning and in the evening

Device:
• Atopiclair®
1 application in the morning, in the afternoon and in the evening

Drug:
• Locatop@
During the Run-In period: 1 application in the morning and in the evening during a maximum of 21 days
• Locapred@
During the 3 months study treatment: 1 application in the evening in case of flare "

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pierre Fabre Medicament

Countries where clinical trial is conducted

Estonia,  France,  Lithuania,  Poland,  Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with at least one flare over the treatment period	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).	12 weeks of treatment.	No