Efficacy Study of Topical Twice Weekly Fluticasone Treatment to Reduce Relapse in Atopic Dermatitis in Children
Overview[ - collapse ][ - ]
Purpose | 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. |
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Condition | Dermatitis, Atopic |
Intervention | Drug: Fluticasone, cream Drug: Placebo, |
Phase | Phase 3 |
Sponsor | Elena Rubio Gomis |
Responsible Party | University of Valencia |
ClinicalTrials.gov Identifier | NCT01772056 |
First Received | January 16, 2013 |
Last Updated | January 20, 2013 |
Last verified | January 2013 |
Tracking Information[ + expand ][ + ]
First Received Date | January 16, 2013 |
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Last Updated Date | January 20, 2013 |
Start Date | December 2009 |
Estimated Primary Completion Date | March 2013 |
Current Primary Outcome Measures | Relapse in Atopic Dermatitis (AD). [Time Frame: 16 weeks] [Designated as safety issue: No]The primary study end point will be probability of a relapse of AD occurring (the relapse rate of AD). |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Efficacy Study of Topical Twice Weekly Fluticasone Treatment to Reduce Relapse in Atopic Dermatitis in Children |
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Official Title | Randomised Controlled, Double Blind Trial of Topical Twice Weekly Fluticasone Propionate Maintenance Treatment to Reduce Risk of Relapse in Mild or Moderate Atopic Dermatitis in Children |
Brief 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. |
Detailed 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. |
Study Type | Interventional |
Study Phase | Phase 3 |
Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention |
Condition | Dermatitis, Atopic |
Intervention | 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. |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Recruiting |
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Estimated Enrollment | 100 |
Estimated Completion Date | March 2013 |
Estimated Primary Completion Date | January 2012 |
Eligibility 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. |
Gender | Both |
Ages | 2 Years |
Accepts Healthy Volunteers | No |
Contacts | Contact: Alejandro Bernalte, Pharmacist 34961972000 bernalte_ale@gva.es |
Location Countries | Spain |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01772056 |
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Other Study ID Numbers | FLUTIDANENES08 |
Has Data Monitoring Committee | No |
Information Provided By | University of Valencia |
Study Sponsor | Elena Rubio Gomis |
Collaborators | Instituto de Salud Carlos III Fundación para la Investigación del Hospital Clínico de Valencia |
Investigators | Principal Investigator: Elena Rubio Gomis, PhD MD Consorcio Hospital General Universitario de Valencia y Universidad de Valencia |
Verification Date | January 2013 |
Locations[ + expand ][ + ]
Departamento de Salud Valencia-La Ribera | Alzira, Valencia, Spain, 46600 Contact: Vicente Palop Larrea, PhD MD | 962458190 | vpalop@hospital-ribera.comSub-Investigator: Vicente Palop Larrea, PhD MD Recruiting |
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Departamento de Salud Valencia - Hospital General | Valencia, Spain, 46014 Contact: Bernalte | bernalte_ale@gva.esSub-Investigator: Antonio Martorell Aragones, PhD MD Recruiting |
Departamento de Salud Valencia-Arnau-Lliria | Valencia, Spain, 46015 Contact: Laura Aranda Grau, PhD MD | 34962761208 | laura_arandagrau@yahoo.esSub-Investigator: Antonio M Abella Bazataqui, PhD MD Recruiting |
Departamento Valencia-Clinic-Malvarrosa | Valencia, Spain, 46010 Contact: Rosario Carpi Lobaton, MD | 34961851461 | paalcri@hotmail.comSub-Investigator: Rosario Carpi Lobaton, MD Recruiting |