Atopic DermatitisPhase 2NCT00882245
Safety and Efficacy of SRD441 Ointment in Patients With Atopic Dermatitis
A Phase 2 study testing Ointment in people with Atopic Dermatitis, run by Serentis Ltd. at 12 sites in 3 countries.
Trial summary
Atopic Dermatitis is a chronic inflammatory skin disease that affect 10 to 15% of children and 2 to 10% of adults. AD is characterised by an itchy skin eruption and may cover large parts of the body. The exact cause is unknown but is thought to be an interplay between genetic and and environmental factors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Ointment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 93 participants
- Where
- 12 sitesin 3 countries
- Study dates
- Apr 2009to Oct 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects aged 18 or over
- Subjects with a history of AD
- Written and dated informed consent
- Satisfactory medical assessment with no clinical relevant abnormalities.
Who cannot join
- Subjects with current or recurrent disease (except AD) that could affect the site of application, the action, absorption or disposition of the investigational product, or clinical or laboratory assessments.
- Subjects who have medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgement of the investigator, would make the subject inappropriate for entry into this trial.
- Subjects with any skin tattoo, scar, cuts, bruises, or other skin damage, including excessive UV exposure, at the possible drug application sites which could impact the application of the test agent or confound the local assessments during this study.
- Subjects with clinically significant renal and liver parameters, as defined as greater than 1.5 x creatinine and 3 x AST ULN (upper limit of normal) respectively.
Trial locations and contacts
12 sites in 3 countries.
12 sites in 3 countries
Germany9 sites
Study site
Berlin
Study site
Bonn
Study site
Cologne
Study site
Frankfurt
Study site
Hanover
Study site
Heidelberg
Study site
Kiel
Study site
Munich
Study site
Münster
About this study
Official title: A Phase II, Double-Blind, Vehicle Controlled Study to Determine the Efficacy, Safety and Toleration of SRD441 Ointment in Patients With Atopic Dermatitis
Atopic Dermatitis is a chronic inflammatory skin disease that affect 10 to 15% of children and 2 to 10% of adults. AD is characterised by an itchy skin eruption and may cover large parts of the body. The exact cause is unknown but is thought to be an interplay between genetic and and environmental factors. The objective of this study is to determine whether SRD441 ointment is a safe and effective therapy for mild to moderate Atopic Dermatitis.
- Conditions
- Atopic Dermatitis
- Being tested
- Vehicle ointment, Ointment
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vehicle ointmentOther
Topical vehicle cream
OintmentDrug
SRD441 Ointment
| Study group | Role | What they receive |
|---|---|---|
| Vehicle ointment | Placebo comparator | Not described Receives: Other: Vehicle ointment |
| SRD441 Ointment | Experimental | Not described Receives: Drug: Ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure efficacy in treating acute exacerbations
Measured: 4 weeks
Secondary outcomes (1)
Safety and local dermal tolerability
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionAug 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Serentis Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Robert Tansley, Study director, Serentis Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00882245
- Sponsor's protocol ID
- P441201CD
- Status last verified
- Oct 2009
- First submitted
- 15 Apr 2009
- Last updated
- 30 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Foelster Holst R, Reitamo S, Yankova R, Worm M, Kadurina M, Thaci D, Bieber T, Tsankov N, Enk A, Luger T, Duffy M, Tansley R. The novel protease inhibitor SRD441 ointment is not effective in the treatment of adult subjects with atopic dermatitis: results of a randomized, vehicle-controlled study. Allergy. 2010 Dec;65(12):1594-9. doi: 10.1111/j.1398-9995.2010.02417.x. Epub 2010 Sep 7.
PubMed 21039597
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Double-Blind, Vehicle Controlled Study to Determine the Efficacy, Safety and Toleration of SRD441 Ointment in Patients With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT00882245
- Acronym / sponsor ID
- P441201CD
- Conditions
- Atopic Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Serentis Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 16 Apr 2009 (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.
Atopic Dermatitis is a chronic inflammatory skin disease that affect 10 to 15% of children and 2 to 10% of adults. AD is characterised by an itchy skin eruption and may cover large parts of the body. The exact cause is unknown but is thought to be an interplay between genetic and and environmental factors. The objective of this study is to determine whether SRD441 ointment is a safe and effective therapy for mild to moderate Atopic Dermatitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vehicle ointment | Placebo comparator | Other: Vehicle ointment |
| SRD441 Ointment | Experimental | Drug: Ointment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female subjects aged 18 or over
- Subjects with a history of AD
- Written and dated informed consent
- Satisfactory medical assessment with no clinical relevant abnormalities.
Key exclusion criteria (4 listed)
- Subjects with current or recurrent disease (except AD) that could affect the site of application, the action, absorption or disposition of the investigational product, or clinical or laboratory assessments.
- Subjects who have medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgement of the investigator, would make the subject inappropriate for entry into this trial.
- Subjects with any skin tattoo, scar, cuts, bruises, or other skin damage, including excessive UV exposure, at the possible drug application sites which could impact the application of the test agent or confound the local assessments during this study.
- Subjects with clinically significant renal and liver parameters, as defined as greater than 1.5 x creatinine and 3 x AST ULN (upper limit of normal) respectively.
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 |
|---|---|---|
| Vehicle ointmentTopical vehicle cream | Other | Vehicle ointment |
| OintmentSRD441 Ointment | Drug | SRD441 Ointment |
Primary outcome
Measure efficacy in treating acute exacerbations
Time frame: 4 weeks
1 secondary outcome
Safety and local dermal tolerability
Time frame: 4 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 30 Oct 2009.
- Derived from this study: PubMed 21039597Foelster Holst R, Reitamo S, Yankova R, Worm M, Kadurina M, Thaci D, Bieber T, Tsankov N, Enk A, Luger T, Duffy M, Tansley R. The novel protease inhibitor SRD441 ointment is not effective in the treatment of adult subjects with atopic dermatitis: results of a randomized, vehicle-controlled study. Allergy. 2010 Dec;65(12):1594-9. doi: 10.1111/j.1398-9995.2010.02417.x. Epub 2010 Sep 7.
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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.
Robert Tansley study director
Serentis Ltd.
12 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ointment in people with Atopic Dermatitis, run by Serentis Ltd. at 12 sites in 3 countries.
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 4 inclusion and 4 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 30 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Germany, Bulgaria, Finland. 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 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 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?
Measure efficacy in treating acute exacerbations (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00882245, which also lists 1 linked publication.
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 30 Oct 2009.