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

NCT01772056 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2015-01-09

No results posted yet for this study

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.

Conditions

  • Dermatitis, Atopic

Interventions

DRUG

Fluticasone, cream

Experimental Group: on treatment with twice weekly on consecutive days FP cream of 0.05% for 16 weeks or at relapse

DRUG

Placebo,

Control Group: on treatment with twice weekly on consecutive days vehicle cream for 16 weeks or at relapse.

Sponsors & Collaborators

  • Instituto de Salud Carlos III

    collaborator OTHER_GOV

  • Fundacion Investigación Hospital General Universitario de Valencia

    collaborator UNKNOWN

  • Elena Rubio Gomis

    lead OTHER

Principal Investigators

  • Elena Rubio Gomis, PhD MD · Consorcio Hospital General Universitario de Valencia y Universidad de Valencia

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2012-01-31
Completion
2013-03-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01772056 on ClinicalTrials.gov