PsoriasisPhase 1NCT00762658
A Phase I Study to Assess Novel Ointment in a Psoriasis Plaque Test
A Phase 1 study testing AN2728 Ointment, 5%, AN2728 Ointment, 2% and AN2728 Ointment, 0.5% in people with Psoriasis, run by Pfizer at 1 site in Germany.
Trial summary
To investigate dose-response relationship, antipsoriatic efficacy and safety of different concentrations of topical formulations of AN2728 in patients with psoriasis vulgaris Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Psoriasis
- What is being tested?
- AN2728 Ointment, 5%, AN2728 Ointment, 2% and AN2728 Ointment, 0.5%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteGermany
- Study dates
- 30 Nov 2007to 7 Dec 2007
- Phase
- Phase 1
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male subjects aged 18 years or older;
- subjects with psoriasis vulgaris in a chronic stable phase and stable plaques with an area sufficient for six treatment fields;
- the physical examination must be without disease findings unless the investigator considers an abnormality to be irrelevant to the outcome of the study;
- written informed consent obtained.
Who cannot join
- subjects who require systemically acting medications for the treatment of psoriasis, which might counter or influence the study objectives, e.g. corticosteroids, cytostatics;
- local treatment with antipsoriatics (except for salicylic acid in vaseline) in the 4 weeks preceding and during the study (corticosteroids 8 weeks);
- systemic treatment with antipsoriatics in the three months preceding and during the study;
- treatment with systemic or locally acting medications which might counter or influence the study aim (e.g. glucocorticosteroids, MAO inhibitors, anti-epileptic drugs, anti-psychotic drugs) or medications which are known to provoke or aggravate psoriasis, e.g. β-blocker, antimalarial drugs within two weeks before the beginning of the study and during the study;
- known allergic reactions to the active ingredients or other components of the study preparations or comparators;
- evidence of drug abuse;
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- UV-therapy within four weeks before beginning and during the study;
- symptoms of a clinically significant illness that may influence the outcome of the study in the four weeks before and during the study;
- participation in another clinical trial involving pharmaceutical products in the four weeks preceding and during the study;
- in the opinion of the investigator or physician performing the initial examination the patient should not participate in the study, e.g. due to probable noncompliance or inability to understand the study and give adequately informed consent.
- subject is institutionalized because of legal or regulatory order.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Randomized, Observer-blind, Single-center, Vehicle- And Comparator-controlled, Initial Dose-ranging Study To Assess The Antipsoriatic Efficacy Of Different Concentrations Of An2728 Ointment In A Psoriasis Plaque Test
To investigate dose-response relationship, antipsoriatic efficacy and safety of different concentrations of topical formulations of AN2728 in patients with psoriasis vulgaris
Read the detailed description
The study will be performed in 12 male subjects with stable psoriatic plaques. The study preparations and the comparators will be tested observer-blind. Treatments will be randomly assigned to the test fields. All subjects will receive all treatments, with intraindividual comparison of the treatments.
Altogether six test fields will be examined per subject (three active AN2728 ointments of different concentrations: 5 %, 2 % and 0.5 %, the active ingredient-free vehicle, a marketed corticoid preparation and a marketed topical immunomodulator). The test fields will be treated occlusively over a study period of 12 days. A topical application of approximately 200 uL of each assigned intervention will be administered per treatment, for a total of 10 treatments over a 12-day treatment period.
- Conditions
- Psoriasis
- Being tested
- AN2728 Ointment, 5%, AN2728 Ointment, 2%, AN2728 Ointment, 0.5%, AN2728 Ointment Vehicle, Betnesol®-V Creme, 0.1%
- Keywords
- Plaque Type Psoriasis, Topical
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AN2728 Ointment, 5%Drug
AN2728 Ointment, 2%Drug
AN2728 Ointment, 0.5%Drug
AN2728 Ointment VehicleDrug
Betnesol®-V Creme, 0.1%Drug
Also called betamethasone 0.1%
Protopic® Ointment, 0.1 %Drug
Also called tacrolimus 0.1 %
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | AN2728 Ointment, 5% Receives: Drug: AN2728 Ointment, 5% |
| 2 | Experimental | AN2728 Ointment, 2% Receives: Drug: AN2728 Ointment, 2% |
| 3 | Experimental | AN2728 Ointment, 0.5% Receives: Drug: AN2728 Ointment, 0.5% |
| 4 | Placebo comparator | AN2728 Ointment Vehicle Receives: Drug: AN2728 Ointment Vehicle |
| 5 | Active comparator | Betnesol®-V Creme (betamethasone 0.1 %) Receives: Drug: Betnesol®-V Creme, 0.1% |
| 6 | Active comparator | Protopic® Ointment (tacrolimus 0.1 %) Receives: Drug: Protopic® Ointment, 0.1 % |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of the Active Study Preparations Compared to the Corresponding Vehicle Using Differences in Infiltrate Thickness on Study Day 12
Measured: Day 12
Secondary outcomes (4)
Change in Infiltrate Thickness
Measured: Day 8
Sonographic Measurements of Infiltrate Thickness
Measured: Day 8, Day 12
The AUC of the Infiltrate Thickness
Measured: Day 8, Day 12
Clinical Assessment Scores for Assessment of Efficacy
Measured: Day 8, Day 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2008 (estimated)
- Study start30 Nov 2007
- Primary completion7 Dec 2007
- Study completion7 Dec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by PfizerThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00762658
- Sponsor's protocol ID
- AN2728-PSR-102
- Other IDs
- 2007-003983-23, C3291021
- Status last verified
- Feb 2019
- First submitted
- 26 Sep 2008
- Last updated
- 22 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Observer-blind, Single-center, Vehicle- And Comparator-controlled, Initial Dose-ranging Study To Assess The Antipsoriatic Efficacy Of Different Concentrations Of An2728 Ointment In A Psoriasis Plaque Test
- ClinicalTrials.gov ID
- NCT00762658
- Acronym / sponsor ID
- AN2728-PSR-102
- Conditions
- Psoriasis
- Keywords
- Plaque Type Psoriasis, Topical
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2007 (actual)
- Primary completion
- 7 Dec 2007 (actual)
- Study completion
- 7 Dec 2007 (actual)
- First posted
- 30 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.
To investigate dose-response relationship, antipsoriatic efficacy and safety of different concentrations of topical formulations of AN2728 in patients with psoriasis vulgaris
Detailed description
The study will be performed in 12 male subjects with stable psoriatic plaques. The study preparations and the comparators will be tested observer-blind. Treatments will be randomly assigned to the test fields. All subjects will receive all treatments, with intraindividual comparison of the treatments.
Altogether six test fields will be examined per subject (three active AN2728 ointments of different concentrations: 5 %, 2 % and 0.5 %, the active ingredient-free vehicle, a marketed corticoid preparation and a marketed topical immunomodulator). The test fields will be treated occlusively over a study period of 12 days. A topical application of approximately 200 uL of each assigned intervention will be administered per treatment, for a total of 10 treatments over a 12-day treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AN2728 Ointment, 5%AN2728 Ointment, 5% |
| 2 | Experimental | Drug: AN2728 Ointment, 2%AN2728 Ointment, 2% |
| 3 | Experimental | Drug: AN2728 Ointment, 0.5%AN2728 Ointment, 0.5% |
| 4 | Placebo comparator | Drug: AN2728 Ointment VehicleAN2728 Ointment Vehicle |
| 5 | Active comparator | Drug: Betnesol®-V Creme, 0.1%Betnesol®-V Creme (betamethasone 0.1 %) |
| 6 | Active comparator | Drug: Protopic® Ointment, 0.1 %Protopic® Ointment (tacrolimus 0.1 %) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- male subjects aged 18 years or older;
- subjects with psoriasis vulgaris in a chronic stable phase and stable plaques with an area sufficient for six treatment fields;
- the physical examination must be without disease findings unless the investigator considers an abnormality to be irrelevant to the outcome of the study;
- written informed consent obtained.
Key exclusion criteria (11 listed)
- subjects who require systemically acting medications for the treatment of psoriasis, which might counter or influence the study objectives, e.g. corticosteroids, cytostatics;
- local treatment with antipsoriatics (except for salicylic acid in vaseline) in the 4 weeks preceding and during the study (corticosteroids 8 weeks);
- systemic treatment with antipsoriatics in the three months preceding and during the study;
- treatment with systemic or locally acting medications which might counter or influence the study aim (e.g. glucocorticosteroids, MAO inhibitors, anti-epileptic drugs, anti-psychotic drugs) or medications which are known to provoke or aggravate psoriasis, e.g. β-blocker, antimalarial drugs within two weeks before the beginning of the study and during the study;
- known allergic reactions to the active ingredients or other components of the study preparations or comparators;
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 |
|---|---|---|
| AN2728 Ointment, 5% | Drug | 1 |
| AN2728 Ointment, 2% | Drug | 2 |
| AN2728 Ointment, 0.5% | Drug | 3 |
| AN2728 Ointment Vehicle | Drug | 4 |
| Betnesol®-V Creme, 0.1%Also: betamethasone 0.1% | Drug | 5 |
| Protopic® Ointment, 0.1 %Also: tacrolimus 0.1 % | Drug | 6 |
Primary outcome
Efficacy of the Active Study Preparations Compared to the Corresponding Vehicle Using Differences in Infiltrate Thickness on Study Day 12
Time frame: Day 12
4 secondary outcomes
Change in Infiltrate Thickness
Time frame: Day 8
Sonographic Measurements of Infiltrate Thickness
Time frame: Day 8, Day 12
The AUC of the Infiltrate Thickness
Time frame: Day 8, Day 12
Clinical Assessment Scores for Assessment of Efficacy
Time frame: Day 8, Day 12
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 22 Feb 2019.
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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.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AN2728 Ointment, 5%, AN2728 Ointment, 2% and AN2728 Ointment, 0.5% in people with Psoriasis, run by Pfizer at 1 site in Germany.
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 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 22 Feb 2019. 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 Germany. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Efficacy of the Active Study Preparations Compared to the Corresponding Vehicle Using Differences in Infiltrate Thickness on Study Day 12 (time frame: Day 12). 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 22 Feb 2019.