Efficacy Study of Topical Twice Weekly Fluticasone Treatment to Reduce Relapse in Atopic Dermatitis in Children

Elena Rubio Gomis

Status and phase: Terminated; Phase 3

Conditions: Dermatitis, Atopic

Treatments: Drug: Fluticasone, cream; Drug: Placebo,

Study type: Interventional

Funder types: Other

Identifiers

NCT01772056

2008-005360-14 (EudraCT Number)

FLUTIDANENES08

EC08/00004 (Other Grant/Funding Number)

Details and patient eligibility

About

The relapsing nature of atopic dermatitis (AD) presents a challenge for its long-term treatment. Efficacy and safety of corticosteroids have been proven in the acute treatment of AD, but not its efficacy and security to reduce or prevent relapses.

Objectives To investigate long-term management (16 weeks) of AD with fluticasone propionate (FP) 0,05% cream twice weekly in addition to an emollient (vehicle) after stabilization of an acute flare of AD with FP cream.

Full description

Patients 2-10 years of age with a history of mild to moderate AD will be eligible for this multicentre, randomized, double-blind, controlled study if they present an acute flare of AD (<30% affected body surface area; no head). After successful treatment of the flare in an acute phase, patients will receive either, FP twice weekly plus vehicle or vehicle alone over a 16-week maintenance phase. The primary study end point will be probability of a relapse of AD occurring. We will conduct survivor analysis of results.

Enrollment: 54 patients

Sex: All

Ages: 2 to 10 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children, aged 2 to 10 years, with mild or moderate acute flare of AD (SCORAD up to 50) and no treatment for this episode of AD.
• written informed consent to patients' parents.

Exclusion criteria

• >30% of affected body surface area AD.
• Head affected.
• Fluticasone o vehicle allergy.
• Patients with any medical condition for which topical corticosteroids were contraindicated
• Patients with other dermatological conditions that may have prevented accurate assessment of AD
• Patients with receiving any concomitant medications that might have affected the study's outcome.
• Other medical history that could interfere with the evaluation of study treatment.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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54 participants in 2 patient groups, including a placebo group

Fluticasone, cream

Experimental group

Description:

fluticasone propionate (FP) cream of 0.05%. The vehicle is:Base PFCO/W, Propyleneglycol and Water conservant.

Treatment:

Drug: Fluticasone, cream

Placebo, cream

Placebo Comparator group

Description:

Vehicle cream is composed by Base PFCO/W, Propyleneglycol and Water conservant.

Treatment:

Drug: Placebo,