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| ID | Type | Description | Link |
|---|---|---|---|
| EC08/00004 | Other Grant/Funding Number | Instituto de Salud Carlos III (ISCIII). Spain | |
| 2008-005360-14 | EudraCT Number |
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Patient recruitment is very slow, economic grant has ended and the number of patients is enough according to sample size (22 children/ arm).
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| Name | Class |
|---|---|
| Instituto de Salud Carlos III | OTHER_GOV |
| Fundacion Investigación Hospital General Universitario de Valencia | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluticasone, cream | Experimental | fluticasone propionate (FP) cream of 0.05%. The vehicle is:Base PFCO/W, Propyleneglycol and Water conservant. |
|
| Placebo, cream | Placebo Comparator | Vehicle cream is composed by Base PFCO/W, Propyleneglycol and Water conservant. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluticasone, cream | Drug | Experimental Group: on treatment with twice weekly on consecutive days FP cream of 0.05% for 16 weeks or at relapse |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relapse in Atopic Dermatitis (AD). | The primary study end point will be probability of a relapse of AD occurring (the relapse rate of AD). | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time to relapse | The number of days from start of the Fluticasone propionate treatment in Double-blind Maintenance Phase (DMP) until AD relapse. | 16 weeks |
| Incidence of relapse | The proportion of children experiencing a relapse of AD during DMP. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elena Rubio Gomis, PhD MD | Consorcio Hospital General Universitario de Valencia y Universidad de Valencia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Departamento de Salud Valencia-La Ribera | Alzira | Valencia | 46600 | Spain | ||
| Departamento Valencia-Clinic-Malvarrosa |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| ID | Term |
|---|---|
| D000068298 | Fluticasone |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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| Placebo, | Drug | Control Group: on treatment with twice weekly on consecutive days vehicle cream for 16 weeks or at relapse. |
|
| 16 weeks |
| severity of the relapse | Severity of AD was scored by means of the modified Scoring of Atopic Dermatitis system (SCORAD).The difference of SCORAD intensity between initial values, Open-label Stabilization Phase (OSP), and end values (end of DMP) | 16 weeks |
| Adverse events and adverse effects | Safety was assessed by monitoring adverse events and adverse effects throughout the study. | 22 weeks |
| Therapeutic compliance | To describe the therapeutic compliance by means of the control of the drug used. | 18 weeks |
| Valencia |
| Valencia |
| 46010 |
| Spain |
| Departamento de Salud Valencia - Hospital General | Valencia | Valencia | 46014 | Spain |
| Departamento de Salud Valencia-Arnau-Lliria | Valencia | Valencia | 46015 | Spain |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |