Dermatitis, AtopicPhase 4NCT00690105
Protopic Ointment in Adult Atopic Eczema of the Face
A Phase 4 study testing tacrolimus 0.1% and fluticasone 0.005 % in people with Dermatitis, Atopic, run by Astellas Pharma Inc at 1 site in France.
Trial summary
Patients with facial atopic eczema and a poor response to topical corticosteroid applied either Protopic or Fluticasone ointment twice a day for 3 weeks. They could continue during 3 more weeks once a day if needed or change for the other ointment. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Dermatitis, Atopic
- What is being tested?
- tacrolimus 0.1% and fluticasone 0.005 %
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 577 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2004to Jul 2005
- Phase
- Phase 4
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Moderate to severe AD (Rajka \& Langeland score) with lesions to the head and neck defined as 'red face' or 'facial eczema': erythema affecting at least 10% of the surface of the 'face' (head, neck, chest, nape of neck), due to long-term AD
- At least two flare-ups of 'facial' eczema during the 12 months prior to inclusion and, in the investigator's opinion, conventional treatment had proved ineffective or poorly tolerated
- Female patients of childbearing age: effective means of contraception throughout the period of the study and for four weeks following the end of the study
- Informed consent
- Therapeutic washout for atopic dermatitis treatments
Who cannot join
- Genetic epidermal barrier defect, such as Netherton's syndrome, or suffering from erythroderma
- Seborrheic dermatitis or contact dermatitis affecting the 'face', or any other facial erythema of non-atopic origin
- Clinical infection due to the VZV virus (varicella, zona), HSV1-2 viruses (herpes), verruca vulgaris or molluscum contagiosum
- Superinfected eczema
- Known hypersensitivity to macrolides or to any other excipient in tacrolimus 0.1% ointment
- Known hypersensitivity to one of the agents contained in the fluticasone 0.005% ointment preparation
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- Ulcerated lesions, of whatever type
- Moderate to severe acne or rosacea
- Patients who participated at the same time in another clinical study or who had participated in another clinical study within 28 days prior to inclusion in the study
- Any type of substance abuse (including that of drugs and alcohol) or any mental disorder/psychological state which, in the investigator's opinion, might interfere with the patient's follow-up
- Serologically-proven HIV positivity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative, Multicentre, Randomized, Double-blind Study to Assess the Efficacy of Tacrolimus 0.1% Ointment Versus Fluticasone 0.005% Ointment in Adult Patients Suffering From Moderate to Severe Atopic Dermatitis and Presenting With So-called 'Red Face' Lesions of the Head and Neck.
Patients with facial atopic eczema and a poor response to topical corticosteroid applied either Protopic or Fluticasone ointment twice a day for 3 weeks. They could continue during 3 more weeks once a day if needed or change for the other ointment.
Read the detailed description
Treatments were to be applied twice daily over all lesions on the face (except for the eyelids) until clearance, for a maximum of 3 weeks and then, in case of uncleared residual lesions, once daily for up to 3 further weeks. In the event of a flare-up the treatment was to be resumed twice a day until the end of the study.
- Conditions
- Dermatitis, Atopic
- Being tested
- tacrolimus 0.1%, fluticasone 0.005 %
- Keywords
- Dermatitis, Atopic, Dermatologic Agents, Topical Drug Administration, Tacrolimus, Calcineurin, Corticosteroid, Fluticasone propionate, Face
- Medical subject headings
- Dermatitis, Atopic, Facies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tacrolimus 0.1%Drug
Also called Protopic® 0.1%
ointment
fluticasone 0.005 %Drug
Also called Flixovate® 0.005%
ointment
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: tacrolimus 0.1% |
| B | Active comparator | Not described Receives: Drug: fluticasone 0.005 % |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients presenting at the week 3 visit (day 21) with an improvement of at least 60% in their local mEASI score (mLEASI) compared to Baseline (day 1).
Measured: 3 weeks
Secondary outcomes (11)
Percentage of patients no longer presenting with 'facial' erythema at day 7 and day 21
Measured: 1 week and 3 weeks
Assessment of facial pruritus at day 1, day 7 and day 21
Measured: 1 week and 3 weeks
Global assessment of clinical response on the 'face' by the physician at day 7 and day 21
Measured: 1 week and 3 weeks
Global assessment of clinical response on the 'face' by the patient at day 7 and day 21
Measured: 1 week and 3 weeks
Patient's quality of life at day 1 and day 21
Measured: 1 week and 3 weeks
mLEASI score values at day 7 and day 21
Measured: 1 week and 3 weeks
Physician's assessment of individual signs
Measured: 1 week and 3 weeks
Quality of sleep at day 1, day 7 and day 21
Measured: 1 week and 3 weeks
Affected surface area assessment at day 1, day 7 and day 21
Measured: 1 week and 3 weeks
Number of patients using the ointment from the other group to treat facial lesions after day 21
Measured: 3 weeks
Incidences of adverse events during the study period
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2008 (estimated)
- Study startFeb 2004
- Primary completionJul 2005
- Study completionJul 2005
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 577 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Central Contact, Study director, Astellas Pharma Europe B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00690105
- Sponsor's protocol ID
- FG-506-06-FR-04
- Other IDs
- EUDRACT #: 2004-002477-23
- Status last verified
- Aug 2014
- First submitted
- 2 Jun 2008
- Last updated
- 1 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative, Multicentre, Randomized, Double-blind Study to Assess the Efficacy of Tacrolimus 0.1% Ointment Versus Fluticasone 0.005% Ointment in Adult Patients Suffering From Moderate to Severe Atopic Dermatitis and Presenting With So-called 'Red Face' Lesions of the Head and Neck.
- ClinicalTrials.gov ID
- NCT00690105
- Acronym / sponsor ID
- FG-506-06-FR-04
- Conditions
- Dermatitis, Atopic
- Keywords
- Dermatitis, Atopic, Dermatologic Agents, Topical Drug Administration, Tacrolimus, Calcineurin, Corticosteroid, Fluticasone propionate, Face
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 577 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Feb 2004
- Primary completion
- Jul 2005 (actual)
- Study completion
- Jul 2005 (actual)
- First posted
- 4 Jun 2008 (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.
Patients with facial atopic eczema and a poor response to topical corticosteroid applied either Protopic or Fluticasone ointment twice a day for 3 weeks. They could continue during 3 more weeks once a day if needed or change for the other ointment.
Detailed description
Treatments were to be applied twice daily over all lesions on the face (except for the eyelids) until clearance, for a maximum of 3 weeks and then, in case of uncleared residual lesions, once daily for up to 3 further weeks. In the event of a flare-up the treatment was to be resumed twice a day until the end of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: tacrolimus 0.1% |
| B | Active comparator | Drug: fluticasone 0.005 % |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Moderate to severe AD (Rajka \& Langeland score) with lesions to the head and neck defined as 'red face' or 'facial eczema': erythema affecting at least 10% of the surface of the 'face' (head, neck, chest, nape of neck), due to long-term AD
- At least two flare-ups of 'facial' eczema during the 12 months prior to inclusion and, in the investigator's opinion, conventional treatment had proved ineffective or poorly tolerated
- Female patients of childbearing age: effective means of contraception throughout the period of the study and for four weeks following the end of the study
- Informed consent
- Therapeutic washout for atopic dermatitis treatments
Key exclusion criteria (11 listed)
- Genetic epidermal barrier defect, such as Netherton's syndrome, or suffering from erythroderma
- Seborrheic dermatitis or contact dermatitis affecting the 'face', or any other facial erythema of non-atopic origin
- Clinical infection due to the VZV virus (varicella, zona), HSV1-2 viruses (herpes), verruca vulgaris or molluscum contagiosum
- Superinfected eczema
- Known hypersensitivity to macrolides or to any other excipient in tacrolimus 0.1% ointment
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 |
|---|---|---|
| tacrolimus 0.1%Also: Protopic® 0.1%ointment | Drug | A |
| fluticasone 0.005 %Also: Flixovate® 0.005%ointment | Drug | B |
Primary outcome
Percentage of patients presenting at the week 3 visit (day 21) with an improvement of at least 60% in their local mEASI score (mLEASI) compared to Baseline (day 1).
Time frame: 3 weeks
11 secondary outcomes
Percentage of patients no longer presenting with 'facial' erythema at day 7 and day 21
Time frame: 1 week and 3 weeks
Assessment of facial pruritus at day 1, day 7 and day 21
Time frame: 1 week and 3 weeks
Global assessment of clinical response on the 'face' by the physician at day 7 and day 21
Time frame: 1 week and 3 weeks
Global assessment of clinical response on the 'face' by the patient at day 7 and day 21
Time frame: 1 week and 3 weeks
Patient's quality of life at day 1 and day 21
Time frame: 1 week and 3 weeks
mLEASI score values at day 7 and day 21
Time frame: 1 week and 3 weeks
Physician's assessment of individual signs
Time frame: 1 week and 3 weeks
Quality of sleep at day 1, day 7 and day 21
Time frame: 1 week and 3 weeks
Affected surface area assessment at day 1, day 7 and day 21
Time frame: 1 week and 3 weeks
Number of patients using the ointment from the other group to treat facial lesions after day 21
Time frame: 3 weeks
Incidences of adverse events during the study period
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2014.
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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.
Central Contact study director
Astellas Pharma Europe B.V.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing tacrolimus 0.1% and fluticasone 0.005 % in people with Dermatitis, Atopic, run by Astellas Pharma Inc at 1 site in France.
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 5 inclusion and 11 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: finished, as of the sponsor's last update on 1 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of patients presenting at the week 3 visit (day 21) with an improvement of at least 60% in their local mEASI score (mLEASI) compared to Baseline (day 1). (time frame: 3 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 1 Sep 2014.