AN2728 Topical Ointment to Treat Mild-to-Moderate Plaque-Type Psoriasis
NCT01300052
ABOUT THIS STUDY
FOR MORE INFORMATION
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- Clinical diagnosis of stable mild-to-moderate plaque-type psoriasis involving 2-35% of total body surface area (BSA) excluding face, scalp, and genitals
- Willingness and ability to apply study medication as directed, comply with study instructions, and commit to attending all study visits
- Women of childbearing potential must agree to use contraception for the entire study period
- Any dermatological conditions that could interfere with clinical evaluations
- Concurrent or recent use of certain topical or systemic medications without a
sufficient washout period
- Significant confounding conditions as assessed by study doctor
- Participated in any other trial of an investigational drug within 30 days or
participation in a research study concurrent with this study
- 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
- Pregnancy or lactation
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Descriptive Information | ||||
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Brief Title ICMJE | AN2728 Topical Ointment to Treat Mild-to-Moderate Plaque-Type Psoriasis | |||
Official Title ICMJE | A Multicenter, Randomized, Double-Blind, 12-Week Study Of The Safety And Efficacy Of AN2728 Versus AN2728 Vehicle In The Treatment Of Patients With Mild-To-Moderate Plaque-Type Psoriasis | |||
Brief Summary | The purpose of this study is to determine whether AN2728 topical ointment is a safe and effective treatment for mild-to-moderate plaque-type psoriasis. | |||
Detailed Description | Not Provided | |||
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 | 68 | |||
Original Estimated Enrollment ICMJE | 60 | |||
Actual Study Completion Date ICMJE | June 6, 2011 | |||
Actual Primary Completion Date | June 6, 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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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 | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01300052 | |||
Other Study ID Numbers ICMJE | AN2728-PSR-204 C3291017 ( Other Identifier: Alias Study Number ) | |||
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 | March 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |