DermatitisPhase 2NCT00746382
A Placebo Controlled 4 Week Proof of Concept Study With 0.5% Roflumilast Cream in Patients With Mild Atopic Dermatitis (RO-2351-001-EM)
A Phase 2 study testing Roflumilast cream in people with Dermatitis, run by AstraZeneca.
Trial summary
The aim of this proof of concept study is to show the safety and efficacy of 0.5 % dermal roflumilast cream in the treatment of atopic dermatitis in adults. This is a multicenter, randomized, double-blind, placebo-controlled, parallel group study. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dermatitis
- What is being tested?
- Roflumilast cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2008to Sep 2009
- Phase
- Phase 2
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient /who is able to read, to write and to fully understand English language) has been informed both verbally and in writing about the objectives of the clinical study, the methods, the anticipated benefits and potential risks and the discomfort to which he/she may be exposed, and has given written consent to participation in the study prior to study start and any study-related procedure.
- Patients are suffering from mild, stable atopic dermatitis Male or female patient of any ethnic origin, age 18 years or older presenting a minimum of 2% to a maximum of 5% BSA affected by stable mild atopic dermatitis (IgE > 10)proven by a dermatologist.
- Patients must have at least one target lesion of at least 0.5% BSA.
- No evidence of oozing or crusting atopic dermatitis
- No lichenification of diseased lesions
- No excoriation of diseased lesions
- Patients must be willing to wash out from current active therapy for at least 14 days to Day 1.
- Women of childbearing potential must have a negative pregnancy test at the Screening and Baseline Visits and agree to use a highly effective method of birth control. A highly effective of birth control is defined at those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectable, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner.
Who cannot join
- Patient has spontaneously improving or rapidly deteriorating atopic dermatitis.
- Patient has a physical condition which, in the Investigator´s opinion, might impair evaluation of atopic dermatitis or which exposes the patient to an unacceptable risk by study participation.
- Patient had prolonged exposure to natural or artificial sources of ultraviolet radiation within 30 days prior to the initiation of treatment or is intending to have such exposure during the study that is thought by the Investigator likely to modify the patient´s disease.
- The patient had topical or transdermal treatments, such as but not limited to retinoids, nicotine or hormone replacement therapies, on or near the intended site of application within 14 days prior to first application of study medication. Use of other topical preparations such as those containing vitamins, supplements or herbal within 14 days prior to application.
- Treatment with systemic/locally acting medications/procedures which might counter or influence the study aim within 30 days before the start and during the study /e.g. anti-histamines, topical glucocorticosteroids, pimecrolimus , tacrolimus systematic desensitization)
- Patient is pregnant, nursing or planning a pregnancy during the study period.
- Patient has received an investigational drug or an investigational device within 30 days prior to study start.
- Abuse of alcohol or drugs
About this study
Official title: A Proof of Concept Study With 0.5% Roflumilast Cream in Patients With Mild Atopic Dermatitis
The aim of this proof of concept study is to show the safety and efficacy of 0.5 % dermal roflumilast cream in the treatment of atopic dermatitis in adults. This is a multicenter, randomized, double-blind, placebo-controlled, parallel group study. 2-5 % of the body surface area (BSA) should be covered with a mild form of atopic dermatitis. In a 4-week treatment period 38 mg cream is applied two times daily on 0.5 to 1 % of the BSA. After a screening phase, a washout phase of flexible duration (max 30 days, time depending upon pre-medication), the 28 day treatment phase follows.As roflumilast is a potent antiinflammatory substance, a positive effect on this form of dermal disease is anticipated.
- Conditions
- Dermatitis
- Being tested
- Roflumilast cream, Placebo cream
- Keywords
- Mild atopic dermatitis, Roflumilast cream 0.5%
- Medical subject headings
- Dermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Roflumilast creamDrug
Roflumilast cream 0.5% versus Placebo cream
Placebo creamDrug
Placebo cream
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Roflumilast cream 0.5% Receives: Drug: Roflumilast cream |
| 2 | Placebo comparator | Placebo cream Receives: Drug: Placebo cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of clinical signs and symptoms score, improvement of patient judged pruritus severity
Measured: 28 days
Secondary outcomes (1)
Improvement of atopic dermatitis severity score, change in dermal questionaire, safety and efficacy
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2008 (estimated)
- Study startNov 2008
- Primary completionJun 2009 (estimated)
- Study completionSep 2009 (estimated)
Why it stopped: Study withdrawn due to business decisions. No subjects were treated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DermatitisStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fougera Pharmaceuticals Inc.
- Responsible party
- Sponsor
- Investigators
- AstraZeneca AstraZeneca, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00746382
- Sponsor's protocol ID
- RO-2351-001-EM
- Status last verified
- Oct 2016
- First submitted
- 3 Sep 2008
- Last updated
- 1 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof of Concept Study With 0.5% Roflumilast Cream in Patients With Mild Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT00746382
- Acronym / sponsor ID
- RO-2351-001-EM
- Conditions
- Dermatitis
- Keywords
- Mild atopic dermatitis, Roflumilast cream 0.5%
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study withdrawn due to business decisions. No subjects were treated.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Fougera Pharmaceuticals Inc.
- Study start
- Nov 2008
- Primary completion
- Jun 2009 (estimated)
- Study completion
- Sep 2009 (estimated)
- First posted
- 4 Sep 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.
The aim of this proof of concept study is to show the safety and efficacy of 0.5 % dermal roflumilast cream in the treatment of atopic dermatitis in adults. This is a multicenter, randomized, double-blind, placebo-controlled, parallel group study. 2-5 % of the body surface area (BSA) should be covered with a mild form of atopic dermatitis. In a 4-week treatment period 38 mg cream is applied two times daily on 0.5 to 1 % of the BSA. After a screening phase, a washout phase of flexible duration (max 30 days, time depending upon pre-medication), the 28 day treatment phase follows.As roflumilast is a potent antiinflammatory substance, a positive effect on this form of dermal disease is anticipated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Roflumilast creamRoflumilast cream 0.5% |
| 2 | Placebo comparator | Drug: Placebo creamPlacebo cream |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient /who is able to read, to write and to fully understand English language) has been informed both verbally and in writing about the objectives of the clinical study, the methods, the anticipated benefits and potential risks and the discomfort to which he/she may be exposed, and has given written consent to participation in the study prior to study start and any study-related procedure.
- Patients are suffering from mild, stable atopic dermatitis Male or female patient of any ethnic origin, age 18 years or older presenting a minimum of 2% to a maximum of 5% BSA affected by stable mild atopic dermatitis (IgE > 10)proven by a dermatologist.
- Patients must have at least one target lesion of at least 0.5% BSA.
- No evidence of oozing or crusting atopic dermatitis
- No lichenification of diseased lesions
Key exclusion criteria (8 listed)
- Patient has spontaneously improving or rapidly deteriorating atopic dermatitis.
- Patient has a physical condition which, in the Investigator´s opinion, might impair evaluation of atopic dermatitis or which exposes the patient to an unacceptable risk by study participation.
- Patient had prolonged exposure to natural or artificial sources of ultraviolet radiation within 30 days prior to the initiation of treatment or is intending to have such exposure during the study that is thought by the Investigator likely to modify the patient´s disease.
- The patient had topical or transdermal treatments, such as but not limited to retinoids, nicotine or hormone replacement therapies, on or near the intended site of application within 14 days prior to first application of study medication. Use of other topical preparations such as those containing vitamins, supplements or herbal within 14 days prior to application.
- Treatment with systemic/locally acting medications/procedures which might counter or influence the study aim within 30 days before the start and during the study /e.g. anti-histamines, topical glucocorticosteroids, pimecrolimus , tacrolimus systematic desensitization)
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 |
|---|---|---|
| Roflumilast creamRoflumilast cream 0.5% versus Placebo cream | Drug | 1 |
| Placebo creamPlacebo cream | Drug | 2 |
Primary outcome
Improvement of clinical signs and symptoms score, improvement of patient judged pruritus severity
Time frame: 28 days
1 secondary outcome
Improvement of atopic dermatitis severity score, change in dermal questionaire, safety and efficacy
Time frame: 28 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2016.
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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.
AstraZeneca AstraZeneca study director
AstraZeneca
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Roflumilast cream in people with Dermatitis, run by AstraZeneca.
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 8 inclusion and 8 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: withdrawn, as of the sponsor's last update on 1 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 withdrawn before enrolling participants, so there are no results.
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?
Improvement of clinical signs and symptoms score, improvement of patient judged pruritus severity (time frame: 28 days). 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 Dec 2016.