NCT01779258

Brief 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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
347

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Feb 2013

Shorter than P25 for phase_3

Geographic Reach
5 countries

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 30, 2013

Completed
2 days until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

February 19, 2014

Status Verified

February 1, 2014

Enrollment Period

1 year

First QC Date

January 28, 2013

Last Update Submit

February 18, 2014

Conditions

Atopic Dermatitis

Keywords

xerosisdry skindermatitiseczemaemollientcorticosteroidflare

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (3)

Group 2

OTHER

Active control arm, Locatop@, Locapred@

Device: Atopiclair®Drug: Locatop@Drug: Locapred@

Group 3

OTHER

Absence of emollient treatment, Locatop@, Locapred@

Drug: Locatop@Drug: Locapred@

Group 1

EXPERIMENTAL

glycerol, paraffin (liquid and white soft), Locatop@ , Locapred@

Drug: glycerol, paraffin (liquid and white soft)Drug: Locatop@Drug: Locapred@

Interventions

glycerol, paraffin (liquid and white soft)DRUG

1 application in the morning and in the evening

Also known as: Dexeryl®
Group 1
Atopiclair®DEVICE

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

Group 2
Locatop@DRUG

During the Run-In period: 1 application in the morning and in the evening during a maximum of 21 days

Group 1Group 2Group 3
Locapred@DRUG

During the 3 months study treatment: 1 application in the evening in case of flare "

Group 1Group 2Group 3

Eligibility Criteria

Age2 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age between 2 and 6 years included,
  • After treatment of the current flare, patients should have for randomization an Objective SCORAD score \< 15, with Xerosis intensity≥ 1 and no subjective signs

You may not qualify if:

  • 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,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Unknown Facility

Tallinn, Estonia

Location

Unknown Facility

Tartu, Estonia

Location

Unknown Facility

Bordeaux, France

Location

Unknown Facility

Poitiers, France

Location

Unknown Facility

Vilnius, Lithuania

Location

Unknown Facility

Lodz, Poland

Location

Unknown Facility

Pruszków, Poland

Location

Unknown Facility

Płock, Poland

Location

Unknown Facility

Warsaw, Poland

Location

Unknown Facility

Brasov, Romania

Location

Unknown Facility

Bucharest, Romania

Location

Unknown Facility

Craiova, Romania

Location

Unknown Facility

Iași, Romania

Location

Unknown Facility

Sibiu, Romania

Location

Unknown Facility

Targu Mureş, Romania

Location

MeSH Terms

Conditions

Dermatitis, AtopicDermatitisEczema

Interventions

GlycerolParaffinFluid TherapyDesonide

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Triose Sugar AlcoholsSugar AlcoholsAlcoholsOrganic ChemicalsCarbohydratesHydrocarbonsDrug TherapyTherapeuticsPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2013

First Posted

January 30, 2013

Study Start

February 1, 2013

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

February 19, 2014

Record last verified: 2014-02

Locations

FR(2)RO(6)PL(4)LI(1)ES(2)