PsoriasisPhase 2NCT00759161
Safety and Efficacy Study of A Novel Ointment to Treat Plaque Type Psoriasis
A Phase 2 study testing AN2728 in people with Psoriasis, run by Pfizer at 1 site in Mexico.
Trial summary
The purpose of the study is to determine the safety and efficacy of AN2728 Ointment, 5%, compared to Ointment Vehicle in the treatment of plaque type psoriasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- AN2728
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteMexico
- Study dates
- Nov 2007to Mar 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 or female >18 years of age at time of enrollment.
- The clinical diagnosis of stable plaque psoriasis.
- Two target plaques of similar severity
- ≥ 5 cm2 but ≤ 100 cm2 computed by multiplying the greatest diameter of the plaque by the diameter of the plaque perpendicular to the greatest diameter.
- Bilaterally located (right/left) plaques on the arms or plaques located on the upper and lower trunk. Plaques located on the trunk were to be separated by at least 10 cm and designated by the Investigator as either left/right or front/back.
- Target plaque severity score of 2-4 (mild to moderate).
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- Normal or not clinically significant screening laboratory results.
- Subjects who were willing and able to apply study drug as directed, comply with study instructions, and commit to all follow-up visits.
- Subjects who had the ability to understand, agree to and sign the study Informed Consent Form (ICF) prior to initiation of any protocol related procedures.
Who cannot join
- Any dermatological conditions that could interfere with clinical evaluations or any disease state or physical condition which might expose the patient to an unacceptable risk by study participation
- Any underlying disease(s) or other dermatological conditions that require the use of exclusionary topical or systemic therapy (see below)
- Known sensitivity to any of the components of the study medication
- Spontaneously improving or rapidly deteriorating psoriatic plaques or pustular/exfoliative, guttate, erythrodermic or other non-plaque form of psoriasis
- Concomitant use of topical or systemic therapies that might alter the course of psoriasis
- Females of child bearing potential. Females must be post-menopausal (based on FSH levels) or surgically sterile (oophorectomy)
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- Washout periods of:
- Topical drugs that might alter the course of psoriasis: 2 weeks
- Oral retinoids: 8 weeks
- Non-retinoid systemic drugs that might alter the course of psoriasis: 4 weeks
- PUVA: 4 weeks
- UVB therapy: 4 weeks
- Use of emollients/moisturizers on area(s) to be treated: 2 days prior to baseline visit
- AIDS or AIDS related illness
- Concurrent participation in another drug research study or within 30 days of enrollment
- Use of lithium or hydroxychloroquine containing products (i.e. Plaquenil)
- Use of a beta-blocking medication (i.e. propranolol) if the dose has not been stabilized for at least 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind, Randomized Bilateral Study of the Safety and Efficacy of AN2728 Ointment, 5%, Versus Ointment Vehicle in the Treatment of Patients With Plaque Type Psoriasis
The purpose of the study is to determine the safety and efficacy of AN2728 Ointment, 5%, compared to Ointment Vehicle in the treatment of plaque type psoriasis.
Read the detailed description
This is a multi-center, randomized, double-blind bilateral design. Patients will apply the test articles, AN2728 Ointment, 5%, and Ointment Vehicle twice daily. The assigned study medication will be applied to two comparable treatment targeted plaques identified at baseline. One test article will be applied to one plaque and the other test article to an anatomically distinct plaque. All efficacy evaluations will be measured from only the two plaques identified at the baseline visit.
- Conditions
- Psoriasis
- Being tested
- AN2728, AN2728 Ointment Vehicle
- 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.
AN2728Drug
Also called AN2728 Ointment, 5%
AN2728 Ointment, 5%, twice daily for 4 weeks
AN2728 Ointment VehicleDrug
AN2728 Ointment Vehicle, twice daily for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | AN2728 Ointment, 5% Receives: Drug: AN2728 |
| 2 | Placebo comparator | AN2728 Ointment Vehicle Receives: Drug: AN2728 Ointment Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Greater Decrease in Overall Target Plaque Severity Score (OTPSS) at Day 28
OTPSS is a scale to assess plaque severity. Each target plaque was scored on a severity rating scale ranging from 0 (no plaque) to 8 (very severe plaque), where higher score indicated more severity of a plaque. In this outcome measure, percentage of participants with reduced OTPSS at Day 28 were reported and comparison of ointment and vehicle treated plaque was given as 'Ointment treated plaque versus (vs.) vehicle treated plaque' and 'Vehicle treated plaque vs. ointment treated plaque'.
Measured: Day 28
Secondary outcomes (5)
Change From Baseline in Overall Target Plaque Severity Score (OTPSS) at Day 7,14, 21, 28 and 35
OTPSS is a scale to assess plaque severity. Each target plaque was scored on a severity scale ranging from 0 (no plaque) to 8 (very severe plaque), where higher score indicated more severity of a plaque.
Measured: Baseline (Day 1), Day 7,14, 21, 28, 35
Change From Baseline in Erythema at Day 7,14, 21, 28 and 35
Erythema is used to assess plaque severity. Investigator rated the clinical appearance of erythema on a severity scale, ranging from 0 (no color on plaque, no erythema) to 8 (extreme red color on plaque, severe erythema), where higher score indicated more severe condition.
Measured: Baseline (Day 1), Day 7,14, 21, 28, 35
Change From Baseline in Scaling at Day 7,14, 21, 28 and 35
Scaling is a scale to assess plaque severity. Investigator rated the clinical appearance of scaling on a severity scale, ranging from 0 (no scaling on plaque) to 8 (very thick scales on plaque), where higher score indicated more severe condition.
Measured: Baseline (Day 1), Day 7,14, 21, 28, 35
Change From Baseline in Plaque Elevation at Day 7,14, 21, 28 and 35
Plaque elevation is a scale to assess plaque severity. Investigator rated presence of plaque elevation on a severity scale ranging, from 0 (no plaque elevation) to 8 (very marked plaque elevation), where higher score indicated more severe condition.
Measured: Baseline (Day 1), Day 7,14, 21, 28, 35
Percentage of Participants With Greater Decrease in Overall Target Plaque Severity Score (OTPSS) at Day 7,14, 21 and 35
OTPSS is a scale to assess plaque severity. Each target plaque was scored on a severity rating scale ranging from 0 (no plaque) to 8 (very severe plaque), where higher score indicated more severity of a plaque. In this outcome measure, percentage of participants with reduced OTPSS at Day 7, 14, 21 and 35 were reported and comparison of ointment and vehicle treated plaque was given as 'Ointment treated plaque vs. vehicle treated plaque' and 'Vehicle treated plaque vs. ointment treated plaque'.
Measured: Day 7,14, 21, 35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2008 (estimated)
- Study startNov 2007
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 35 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
- NCT00759161
- Sponsor's protocol ID
- AN2728-PSR-201
- Other IDs
- C3291014
- Status last verified
- Jan 2017
- First submitted
- 23 Sep 2008
- Last updated
- 6 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized Bilateral Study of the Safety and Efficacy of AN2728 Ointment, 5%, Versus Ointment Vehicle in the Treatment of Patients With Plaque Type Psoriasis
- ClinicalTrials.gov ID
- NCT00759161
- Acronym / sponsor ID
- AN2728-PSR-201
- Conditions
- Psoriasis
- Keywords
- Plaque Type Psoriasis, Topical
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 25 Sep 2008 (estimated)
- Results
- Posted 6 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to determine the safety and efficacy of AN2728 Ointment, 5%, compared to Ointment Vehicle in the treatment of plaque type psoriasis.
Detailed description
This is a multi-center, randomized, double-blind bilateral design. Patients will apply the test articles, AN2728 Ointment, 5%, and Ointment Vehicle twice daily. The assigned study medication will be applied to two comparable treatment targeted plaques identified at baseline. One test article will be applied to one plaque and the other test article to an anatomically distinct plaque. All efficacy evaluations will be measured from only the two plaques identified at the baseline visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: AN2728AN2728 Ointment, 5% |
| 2 | Placebo comparator | Drug: AN2728 Ointment VehicleAN2728 Ointment Vehicle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female >18 years of age at time of enrollment.
- The clinical diagnosis of stable plaque psoriasis.
- Two target plaques of similar severity
- Normal or not clinically significant screening laboratory results.
- Subjects who were willing and able to apply study drug as directed, comply with study instructions, and commit to all follow-up visits.
Key exclusion criteria (17 listed)
- Any dermatological conditions that could interfere with clinical evaluations or any disease state or physical condition which might expose the patient to an unacceptable risk by study participation
- Any underlying disease(s) or other dermatological conditions that require the use of exclusionary topical or systemic therapy (see below)
- Known sensitivity to any of the components of the study medication
- Spontaneously improving or rapidly deteriorating psoriatic plaques or pustular/exfoliative, guttate, erythrodermic or other non-plaque form of psoriasis
- Concomitant use of topical or systemic therapies that might alter the course of psoriasis
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 |
|---|---|---|
| AN2728Also: AN2728 Ointment, 5%AN2728 Ointment, 5%, twice daily for 4 weeks | Drug | 1 |
| AN2728 Ointment VehicleAN2728 Ointment Vehicle, twice daily for 4 weeks. | Drug | 2 |
Primary outcome
Percentage of Participants With Greater Decrease in Overall Target Plaque Severity Score (OTPSS) at Day 28
Time frame: Day 28
OTPSS is a scale to assess plaque severity. Each target plaque was scored on a severity rating scale ranging from 0 (no plaque) to 8 (very severe plaque), where higher score indicated more severity of a plaque. In this outcome measure, percentage of participants with reduced OTPSS at Day 28 were reported and comparison of ointment and vehicle treated plaque was given as 'Ointment treated plaque versus (vs.) vehicle treated plaque' and 'Vehicle treated plaque vs. ointment treated plaque'.
5 secondary outcomes
Change From Baseline in Overall Target Plaque Severity Score (OTPSS) at Day 7,14, 21, 28 and 35
Time frame: Baseline (Day 1), Day 7,14, 21, 28, 35
Change From Baseline in Erythema at Day 7,14, 21, 28 and 35
Time frame: Baseline (Day 1), Day 7,14, 21, 28, 35
Change From Baseline in Scaling at Day 7,14, 21, 28 and 35
Time frame: Baseline (Day 1), Day 7,14, 21, 28, 35
Change From Baseline in Plaque Elevation at Day 7,14, 21, 28 and 35
Time frame: Baseline (Day 1), Day 7,14, 21, 28, 35
Percentage of Participants With Greater Decrease in Overall Target Plaque Severity Score (OTPSS) at Day 7,14, 21 and 35
Time frame: Day 7,14, 21, 35
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 2 study testing AN2728 in people with Psoriasis, run by Pfizer at 1 site in Mexico.
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 9 inclusion and 17 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 6 Mar 2017. 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 Mexico. 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?
Yes. Results are posted in the registry (first posted 6 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Participants With Greater Decrease in Overall Target Plaque Severity Score (OTPSS) at Day 28 (time frame: Day 28). 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 6 Mar 2017.