Dermatitis, AtopicPhase 3NCT01772056
Efficacy Study of Topical Twice Weekly Fluticasone Treatment to Reduce Relapse in Atopic Dermatitis in Children
A Phase 3 study testing Fluticasone, cream in people with Dermatitis, Atopic, run by Elena Rubio Gomis at 4 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 10 years
- Conditions the study is for
- Dermatitis, Atopic
- What is being tested?
- Fluticasone, cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 4 sitesSpain
- Study dates
- Dec 2009to Mar 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- >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.
Trial locations and contacts
4 sites in 1 country.
Spain4 sites
Departamento de Salud Valencia-La Ribera
Alzira, Valencia, 46600
Departamento Valencia-Clinic-Malvarrosa
Valencia, Valencia, 46010
Departamento de Salud Valencia - Hospital General
Valencia, Valencia, 46014
Departamento de Salud Valencia-Arnau-Lliria
Valencia, Valencia, 46015
About this study
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
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.
Read the 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.
- Conditions
- Dermatitis, Atopic
- Being tested
- Fluticasone, cream, Placebo,
- Keywords
- Dermatitis, Atopic, Randomized Controlled Trial, Child, Fluticasone, Preventive therapy
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluticasone, creamDrug
Experimental Group: on treatment with twice weekly on consecutive days FP cream of 0.05% for 16 weeks or at relapse
Placebo,Drug
Control Group: on treatment with twice weekly on consecutive days vehicle cream for 16 weeks or at relapse.
| Study group | Role | What they receive |
|---|---|---|
| Fluticasone, cream | Experimental | fluticasone propionate (FP) cream of 0.05%. The vehicle is:Base PFCO/W, Propyleneglycol and Water conservant. Receives: Drug: Fluticasone, cream |
| Placebo, cream | Placebo comparator | Vehicle cream is composed by Base PFCO/W, Propyleneglycol and Water conservant. Receives: Drug: Placebo, |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse in Atopic Dermatitis (AD).
The primary study end point will be probability of a relapse of AD occurring (the relapse rate of AD).
Measured: 16 weeks
Secondary outcomes (5)
Time to relapse
The number of days from start of the Fluticasone propionate treatment in Double-blind Maintenance Phase (DMP) until AD relapse.
Measured: 16 weeks
Incidence of relapse
The proportion of children experiencing a relapse of AD during DMP.
Measured: 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)
Measured: 16 weeks
Adverse events and adverse effects
Safety was assessed by monitoring adverse events and adverse effects throughout the study.
Measured: 22 weeks
Therapeutic compliance
To describe the therapeutic compliance by means of the control of the drug used.
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2013 (estimated)
- Study startDec 2009
- Primary completionJan 2012
- Study completionMar 2013
Why it stopped: Patient recruitment is very slow, economic grant has ended and the number of patients is enough according to sample size (22 children/ arm).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatitis, AtopicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elena Rubio Gomis
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III, Fundacion Investigación Hospital General Universitario de Valencia
- Responsible party
- Sponsor-investigator, Elena Rubio Gomis, University of Valencia
- Investigators
- Elena Rubio Gomis, PhD MD, Principal investigator, Consorcio Hospital General Universitario de Valencia y Universidad de Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01772056
- Sponsor's protocol ID
- FLUTIDANENES08
- Other IDs
- EC08/00004, 2008-005360-14, 2008
- Status last verified
- Jan 2015
- First submitted
- 16 Jan 2013
- Last updated
- 9 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01772056
- Acronym / sponsor ID
- FLUTIDANENES08
- Conditions
- Dermatitis, Atopic
- Keywords
- Dermatitis, Atopic, Randomized Controlled Trial, Child, Fluticasone, Preventive therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Patient recruitment is very slow, economic grant has ended and the number of patients is enough according to sample size (22 children/ arm).
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Elena Rubio GomisUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III, Fundacion Investigación Hospital General Universitario de Valencia
- Study start
- Dec 2009
- Primary completion
- Jan 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 21 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluticasone, cream | Experimental | Drug: Fluticasone, creamfluticasone propionate (FP) cream of 0.05%. The vehicle is:Base PFCO/W, Propyleneglycol and Water conservant. |
| Placebo, cream | Placebo comparator | Drug: Placebo,Vehicle cream is composed by Base PFCO/W, Propyleneglycol and Water conservant. |
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- >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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluticasone, creamExperimental Group: on treatment with twice weekly on consecutive days FP cream of 0.05% for 16 weeks or at relapse | Drug | Fluticasone, cream |
| Placebo,Control Group: on treatment with twice weekly on consecutive days vehicle cream for 16 weeks or at relapse. | Drug | Placebo, cream |
Primary outcome
Relapse in Atopic Dermatitis (AD).
Time frame: 16 weeks
The primary study end point will be probability of a relapse of AD occurring (the relapse rate of AD).
5 secondary outcomes
Time to relapse
Time frame: 16 weeks
Incidence of relapse
Time frame: 16 weeks
severity of the relapse
Time frame: 16 weeks
Adverse events and adverse effects
Time frame: 22 weeks
Therapeutic compliance
Time frame: 18 weeks
Results and safety
The study was stopped early (reason given: Patient recruitment is very slow, economic grant has ended and the number of patients is enough according to sample size (22 children/ arm).). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elena Rubio Gomis, PhD MD principal investigator
Consorcio Hospital General Universitario de Valencia y Universidad de Valencia
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fluticasone, cream in people with Dermatitis, Atopic, run by Elena Rubio Gomis at 4 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Patient recruitment is very slow, economic grant has ended and the number of patients is enough according to sample size (22 children/ arm).). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse in Atopic Dermatitis (AD). (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2015.