Safety and Efficacy Study of A Novel Ointment to Treat Plaque Type Psoriasis
NCT00759161
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
Adult Trials: 18+ Years
1. Male or female >18 years of age at time of enrollment.
2. The clinical diagnosis of stable plaque psoriasis.
3. Two target plaques of similar severity
1. ≥ 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.
2. 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.
3. Target plaque severity score of 2-4 (mild to moderate).
4. Normal or not clinically significant screening laboratory results.
5. Subjects who were willing and able to apply study drug as directed, comply with study instructions, and commit to all follow-up visits.
6. 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.
1. 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
2. Any underlying disease(s) or other dermatological conditions that require the use of
exclusionary topical or systemic therapy (see below)
3. Known sensitivity to any of the components of the study medication
4. Spontaneously improving or rapidly deteriorating psoriatic plaques or
pustular/exfoliative, guttate, erythrodermic or other non-plaque form of psoriasis
5. Concomitant use of topical or systemic therapies that might alter the course of
psoriasis
6. Females of child bearing potential. Females must be post-menopausal (based on FSH
levels) or surgically sterile (oophorectomy)
7. Washout periods of:
1. Topical drugs that might alter the course of psoriasis: 2 weeks
2. Oral retinoids: 8 weeks
3. Non-retinoid systemic drugs that might alter the course of psoriasis: 4 weeks
4. PUVA: 4 weeks
5. UVB therapy: 4 weeks
6. Use of emollients/moisturizers on area(s) to be treated: 2 days prior to baseline
visit
8. AIDS or AIDS related illness
9. Concurrent participation in another drug research study or within 30 days of
enrollment
10. Use of lithium or hydroxychloroquine containing products (i.e. Plaquenil)
11. Use of a beta-blocking medication (i.e. propranolol) if the dose has not been
stabilized for at least 3 months
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Safety and Efficacy Study of A Novel Ointment to Treat Plaque Type Psoriasis | |||
| Official Title ICMJE | 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 | |||
| Brief 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. | |||
| 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 Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 2 | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Treatment | |||
| Condition ICMJE | Psoriasis | |||
| Intervention ICMJE |
| |||
| Study Arms ICMJE |
| |||
| 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 | 35 | |||
| Original Actual Enrollment ICMJE | Same as current | |||
| Actual Study Completion Date ICMJE | March 2008 | |||
| Actual Primary Completion Date | March 2008 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| 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 | NCT00759161 | |||
| Other Study ID Numbers ICMJE | AN2728-PSR-201 C3291014 ( 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 |
| |||
| 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 | ||||