- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00755196
Safety and Efficacy Study of A Novel Ointment to Treat Plaque Type Psoriasis
January 12, 2017 updated by: Pfizer
A Double-Blind, Randomized, 12 Week, 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 this study is to evaluate the safety and efficacy of AN2728 Ointment, 5%, compared to Ointment Vehicle, applied twice daily for 12 weeks, in the treatment of plaque type psoriasis
Study Overview
Detailed Description
This is a single center, randomized, double-blind, vehicle-controlled, bilateral design.
Patients will apply both test articles, AN2728 Ointment, 5%, and Ointment Vehicle twice daily for 12 weeks.
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 Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Distrito Federal
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Mexico City, Distrito Federal, Mexico, 06700
- IMIC
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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 distinct plaques located on the trunk. Plaques located on the trunk must be separated by at least 10 cm and will be designated by the Investigator as either left/right or front/back or upper/lower
- Overall target plaque severity score (OTPSS) of 2-4 (mild to moderate) with no more than a 1 point difference in the scores of the individual plaques
- Normal or not clinically significant screening laboratory results
- Willing and able to apply study drug as directed, comply with study instructions and commit to all follow-up visits
- Ability to understand, agree to and sign the study Informed Consent Form (ICF) prior to initiation of any protocol related procedures
Exclusion Criteria:
- 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 or surgically sterile (oophorectomy).
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 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: 1
AN2728 Ointment, 5%
|
AN2728 Ointment, 5%, twice daily for 12 weeks
Other Names:
|
PLACEBO_COMPARATOR: 2
AN2728 Ointment vehicle
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Ointment vehicle, twice daily for 12 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Lowering of Overall Target Plaque Severity Score (OTPSS) at Day 84
Time Frame: Day 84
|
OTPSS is a scale to assess plaque severity.
Each target plaque was scored by the investigator on severity 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 84 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'.
|
Day 84
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Lowering of Overall Target Plaque Severity Score (OTPSS) At Day 7, 14, 28, 42, 56, 70, 91
Time Frame: Day 7, 14, 28, 42, 56, 70, 91
|
OTPSS is a scale to assess plaque severity.
Each target plaque was scored by the investigator on severity 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, 28, 42, 56, 70 and 91 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'.
|
Day 7, 14, 28, 42, 56, 70, 91
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2008
Primary Completion (ACTUAL)
December 1, 2008
Study Completion (ACTUAL)
December 1, 2008
Study Registration Dates
First Submitted
September 17, 2008
First Submitted That Met QC Criteria
September 17, 2008
First Posted (ESTIMATE)
September 18, 2008
Study Record Updates
Last Update Posted (ACTUAL)
March 6, 2017
Last Update Submitted That Met QC Criteria
January 12, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AN2728-PSR-202
- C3291015 (OTHER: Pfizer)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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