Clinical Trial Results:
Ensayo clínico aleatorizado, doble ciego con propionato de fluticasona tópico 2 veces por semana, como tratamiento de mantenimiento, para reducir el riesgo de recidivas de dermatitis atópica leve o moderada en niño.
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.
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Summary
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EudraCT number |
2008-005360-14 |
Trial protocol |
ES |
Global end of trial date |
27 Apr 2012
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Results information
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Results version number |
v1(current) |
This version publication date |
21 Oct 2022
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First version publication date |
21 Oct 2022
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Other versions |
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Summary report(s) |
Medical jurnal article Rubio-Gomis et al |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
FLUTIDANENES08
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01772056 | ||
WHO universal trial number (UTN) |
- | ||
Other trial identifiers |
ISCIII. Ministerio de Ciencia e Innovación: EC08/00004 | ||
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Sponsors
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Sponsor organisation name |
Instituto de Salud Carlos III
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Sponsor organisation address |
C/ Sinesio Delgado, 4, Madrid, Spain, 28029
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Public contact |
Instituto de Salud Carlos III, Instituto de Salud Carlos III (ISCIII), +34 91 822 24 51, comunicacion@isciii.es
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Scientific contact |
Instituto de Salud Carlos III, Instituto de Salud Carlos III, +34 91 822 24 51, comunicacion@isciii.es
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Sponsor organisation name |
Consorcio Hospital General Universitario de Valencia
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Sponsor organisation address |
Avda Tres Cruces nº2, Valencia, Spain, 46014
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Public contact |
Elena Rubio. Unidad de Farmacología Clínica
Consorcio Hospital General Universitario de Valencia, Elena Rubio.
Consorcio Hospital General Universitario de Valencia, +34 964972140, elena.rubio@uv.es
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Scientific contact |
Elena Rubio. Unidad de Farmacología Clínica
Consorcio Hospital General Universitario de Valencia, Elena Rubio.
Consorcio Hospital General Universitario de Valencia, +34 961972140, elena.rubio@uv.es
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Sponsor organisation name |
Fundacion Investigación Hospital General Universitario de Valencia
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Sponsor organisation address |
Avda Tres Cruces nº2, Valencia, Spain, 46014
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Public contact |
Fundacion Investigación Hospital General Universitario de Valencia, Fundacion Investigación Hospital General Universitario de Valencia, +34 963131893, fundacion_hgv@gva.es
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Scientific contact |
Fundacion Investigación Hospital General Universitario de Valencia, Fundacion Investigación Hospital General Universitario de Valencia, +34 963 131 893, fundacion_hgv@gva.es
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
14 May 2012
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
23 Mar 2012
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Global end of trial reached? |
Yes
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Global end of trial date |
27 Apr 2012
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
El objetivo principal de este estudio es probar la eficacia de Fluticasona propionato al 0.05% en crema frente placebo (vehículo de la crema) aplicada en las zonas de lesión 2 veces por semana hasta la recidiva o un máximo de 16 semanas para disminuir las recidivas de DA en niños de 2 a 10 años.
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Protection of trial subjects |
No specific measures .
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
19 Jan 2010
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Spain: 61
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Worldwide total number of subjects |
61
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EEA total number of subjects |
61
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
61
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||||||||||||||
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Pre-assignment
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Screening details |
A total of 61 patients were assessed for eligibility, ofthese children, seven had failed screening (1 No informed consent; 6 Inclusion/exclusion criterianot met). | ||||||||||||||||||
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Pre-assignment period milestones
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Number of subjects started |
61 | ||||||||||||||||||
Number of subjects completed |
54 | ||||||||||||||||||
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Pre-assignment subject non-completion reasons
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Reason: Number of subjects |
No informed consent: 1 | ||||||||||||||||||
Reason: Number of subjects |
Inclusion/exclusion criteria not met: 6 | ||||||||||||||||||
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Period 1
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Period 1 title |
Open-label Stabi-lization Phase (OSP)
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Is this the baseline period? |
Yes | ||||||||||||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | ||||||||||||||||||
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Arms
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Arm title
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Open-label Stabi-lization Phase (OSP) | ||||||||||||||||||
Arm description |
Children were enrolled into an initial OSP on treatment with twice daily Fruticasone Propionate cream 0.05% up to 2 weeks. Those children who achieved treatment success in OSP entered the DMP. | ||||||||||||||||||
Arm type |
Treatment success | ||||||||||||||||||
Investigational medicinal product name |
Fluticasone propionate
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Investigational medicinal product code |
PR1
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Other name |
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Pharmaceutical forms |
Cream
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Routes of administration |
Cutaneous use
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Dosage and administration details |
Fluticasone propionate cream 0.05% twice daily up to 2 weeks.
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| Notes [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same. Justification: A total of 61 patients were assessed for eligibility, of these children, seven had failed screening. Hence, fifty-four patients entered the OSP, of them 49 continued into the DMP and were randomized (twenty six were in the FP group). |
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Period 2
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Period 2 title |
Double-blind Maintenance Phase (DMP).
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Is this the baseline period? |
No | ||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||||||||
Roles blinded |
Investigator, Monitor, Data analyst, Carer, Assessor, Subject | ||||||||||||||||||
Blinding implementation details |
Randomization was generated by a random number table;the list was produced by the statistical service of the CRO. A blindedcopy and clinical trial coded medication were received andstored by the clinical trials pharmacist at Consorcio HospitalGeneral Universitario de Valencia (CHGUV). The pharma-cist dispensed the research drugs packs according with theresearch assistants that used consecutively numbered packsto allocate new participants to treatment groups.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Fluticasone propionate treatmen | ||||||||||||||||||
Arm description |
To receive Fluticasone propionate twice weekly on consecutive days for 16 weeks or at relapse, in which case they were withdrawn from the study. | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
Fluticasone propionate
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Investigational medicinal product code |
PR1
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Other name |
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Pharmaceutical forms |
Cream
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Routes of administration |
Cutaneous use
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Dosage and administration details |
Fluticasone propionate cream 0.05% twice weekly on consecutive days
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Arm title
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Vehicle treatment | ||||||||||||||||||
Arm description |
To receive vehicle (PFCO/W Base®- Guinama S.L.U., Propyleneglycol and Aqua conservans) twice weekly on consecutive days for 16 weeks or at relapse. | ||||||||||||||||||
Arm type |
Placebo | ||||||||||||||||||
Investigational medicinal product name |
Vehicle
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Investigational medicinal product code |
PL1
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Other name |
PFCO/W Base®- Guinama S.L.U., Propyleneglycol and Aqua conservans.
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Pharmaceutical forms |
Cream
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Routes of administration |
Cutaneous use
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Dosage and administration details |
PFCO/W Base®- Guinama S.L.U., Propyleneglycol and Aqua conservans, twice weekly on consecutive days.
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Baseline characteristics reporting groups
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Reporting group title |
Open-label Stabi-lization Phase (OSP)
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Reporting group description |
- | |||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Open-label Stabi-lization Phase (OSP)
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Reporting group description |
Children were enrolled into an initial OSP on treatment with twice daily Fruticasone Propionate cream 0.05% up to 2 weeks. Those children who achieved treatment success in OSP entered the DMP. | ||
Reporting group title |
Fluticasone propionate treatmen
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Reporting group description |
To receive Fluticasone propionate twice weekly on consecutive days for 16 weeks or at relapse, in which case they were withdrawn from the study. | ||
Reporting group title |
Vehicle treatment
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Reporting group description |
To receive vehicle (PFCO/W Base®- Guinama S.L.U., Propyleneglycol and Aqua conservans) twice weekly on consecutive days for 16 weeks or at relapse. | ||
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End point title |
Relapse of Atopic Dermatitis | |||||||||
End point description |
The primary study endpoint was a relapse rate of Atopic Dermatitis, defined as an SCORAD >5 or ≥25% initial SCORAD.
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End point type |
Primary
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End point timeframe |
16 weeks
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Statistical analysis title |
Log Rank | |||||||||
Statistical analysis description |
Differ-ences between treatment groups were tested using Log Rank (Mantel-Cox).
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Comparison groups |
Fluticasone propionate treatmen v Vehicle treatment
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Number of subjects included in analysis |
49
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||
P-value |
> 0.05 | |||||||||
Method |
Logrank | |||||||||
Confidence interval |
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Adverse events information
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Timeframe for reporting adverse events |
Total study period (2 weeks + 16 weeks)
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Adverse event reporting additional description |
Safety was assessed by monitoring adverse events. Causal relationship of the clinical event to the use of the medication studied was assessed by clinical researchers. The adverse cutaneous reactions related with corticosteroid treatment were particularly considered (skin atrophy, telangiectasia, striae and hypertrichosis).
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
2.0
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Reporting groups
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Reporting group title |
Open-label Stabi-lization Phase (OSP)
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Reporting group description |
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Reporting group title |
fluticasone propionate (FP)
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Vehicle group
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Reporting group description |
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| It was prematurely terminated because patient recruitment was very slow and the economic grant had ended, nonetheless the number of recruited patients was enough according to the estimated sample size, so this study can be conclusive with certainty. | |||
