Emollients in the Management of Atopic Dermatitis

NCT01779258 — Phase 3, Completed, 347 participants, Pierre Fabre Medicament

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

Registry	NCT01779258
Status	Completed
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	347 (Actual)
Sponsor	Pierre Fabre Medicament (Industry)
Conditions	Atopic Dermatitis
Interventions	glycerol, paraffin (liquid and white soft), Atopiclair®, Locatop@, Locapred@ (Drug, device)
Dates	start 2013-02-01, primary completion 2014-02-01, completion 2014-02-01, first posted 2013-01-30, last updated 2014-02-19
Locations	15 sites in Estonia, France, Lithuania, Poland, Romania

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Group 2	Other	Device: Atopiclair®; Drug: Locatop@; Drug: Locapred@	Active control arm, Locatop@, Locapred@
Group 3	Other	Drug: Locatop@; Drug: Locapred@	Absence of emollient treatment, Locatop@, Locapred@
Group 1	Experimental	Drug: glycerol, paraffin (liquid and white soft); Drug: Locatop@; Drug: Locapred@	glycerol, paraffin (liquid and white soft), Locatop@ , Locapred@

glycerol, paraffin (liquid and white soft) (Drug), also known as Dexeryl®: 1 application in the morning and in the evening
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 "

+Outcome measures

Primary outcomes

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

+Eligibility

Sex: All, ages: 2 Years to 6 Years

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,

+Locations (15)

Facility	City	Country	Status
	Tallinn	Estonia
	Tartu	Estonia
	Bordeaux	France
	Poitiers	France
	Vilnius	Lithuania
	Lodz	Poland
	Pruszków	Poland
	Płock	Poland
	Warsaw	Poland
	Brasov	Romania
	Bucharest	Romania
	Craiova	Romania
	Iași	Romania
	Sibiu	Romania
	Targu Mureş	Romania