Safety and Efficacy Study of a Novel Ointment to Treat Plaque Type Psoriasis
NCT01029405
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- Male or female >18 years of age at time of enrollment
- Clinical diagnosis of stable plaque type psoriasis
- Two target plaques of similar severity meeting the following criteria:
- 5 cm2 and ≤ 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 trunk. Plaques located on the trunk must be separated by at least 10 cm 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 two target plaques
- 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
- Any dermatological conditions, disease state or physical condition that could
interfere with clinical evaluations or 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)
- Clinically significant, abnormal Screening laboratory results (unless approved by the
medical monitor)
- 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 (hysterectomy or bilateral oophorectomy)
- Washout periods for exclusionary therapies:
Oral retinoids: 8 weeks Non-retinoid systemic drugs that might alter the course of
psoriasis: 4 weeks Psoralens with UV-A (PUVA): 4 weeks Ultraviolet-B (UVB) therapy: 4 weeks
Topical drugs that might alter the course of psoriasis: 2 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 or device research study or within 30 days
prior to enrollment
- Use of lithium- or hydroxychloroquine-containing products (e.g., Plaquenil)
- Use of a beta-blocking medication (e.g., Propranolol) if the dose has not been
stabilized for at least 3 months
- Use of AN2728 in a previous clinical trial
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Descriptive Information | ||||
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Brief Title ICMJE | Safety and Efficacy Study of a Novel Ointment to Treat Plaque Type Psoriasis | |||
Official Title ICMJE | A Double-Blind,Randomized, 12 Week, Bilateral Study of the Safety and Efficacy of AN2728 Ointment B, 2% and 0.5%, Versus Ointment B Vehicle in the Treatment of Patients With Plaque Type Psoriasis | |||
Brief Summary | The purpose of this study is to evaluate the safety and efficacy of AN2728 Ointment B, 2.0% and 0.5%, compared to Ointment Vehicle B, applied once or twice daily for 12 weeks, in the treatment of plaque type psoriasis | |||
Detailed Description | This is a multicenter, randomized, double-blind, vehicle-controlled, bilateral design. Patients will apply both test article AN2728 Ointment B (0.5% or 2%), and Ointment B 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 ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment | |||
Condition ICMJE | Psoriasis | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 145 | |||
Original Estimated Enrollment ICMJE | 140 | |||
Actual Study Completion Date ICMJE | June 2010 | |||
Actual Primary Completion Date | May 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
Oral retinoids: 8 weeks Non-retinoid systemic drugs that might alter the course of psoriasis: 4 weeks Psoralens with UV-A (PUVA): 4 weeks Ultraviolet-B (UVB) therapy: 4 weeks Topical drugs that might alter the course of psoriasis: 2 weeks Use of emollients/moisturizers on area(s) to be treated: 2 days prior to Baseline visit
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Mexico | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01029405 | |||
Other Study ID Numbers ICMJE | AN2728-PSR-203 C3291016 ( Other Identifier: Pfizer ) | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | January 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |