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

• Status: Terminated
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Elena Rubio Gomis
• Collaborators: Fundacion Investigación Hospital General Universitario de Valencia; Instituto de Salud Carlos III
• Treatments: Fluticasone

Criteria

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.