Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Safety and Efficacy Study of a Novel Ointment to Treat Plaque Type Psoriasis (AN2728PSR203)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01029405
First received: December 7, 2009
Last updated: January 12, 2017
Last verified: January 2017
  Purpose
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

Condition Intervention Phase
Psoriasis
Drug: AN2728
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage of Participants With Greater Decrease In Overall Target Plaque Severity Score (OTPSS): Ointment (2% Twice Daily), Vehicle [ Time Frame: Day 42 ]
    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 indicates more severity of a plaque. In this outcome measure, percentage of participants with reduced OTPSS in ointment (2% twice daily) treated plaque versus (vs.) vehicle treated plaque and percentage of participants with reduced OTPSS in vehicle treated plaque versus ointment (2% twice daily) treated plaque respectively at Day 42 are reported.


Secondary Outcome Measures:
  • Percentage of Participants With Greater Decrease In OTPSS: Ointment (0.5 % Once Daily, 0.5% Twice Daily and 2% Once Daily), Vehicle [ Time Frame: Day 42 ]
    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 scores indicated more severity of a plaque. In this outcome measure, percentage of participants with reduced OTPSS in ointment (0.5 % once daily, 0.5% twice daily and 2% once daily) treated plaque versus vehicle treated plaque and percentage of participants with reduced OTPSS in vehicle treated plaque versus ointment (0.5 % once daily, 0.5% twice daily and 2% once daily) treated plaque respectively at Day 42 are reported.


Enrollment: 145
Study Start Date: November 2009
Study Completion Date: June 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1. AN2728 Ointment B
2%, administered twice daily
Drug: AN2728
Ointment B, 2% or 0.5% applied once or twice daily
Placebo Comparator: 2. AN2728 Ointment B Vehicle Drug: Placebo
Ointment B Vehicle applied once or twice daily
Active Comparator: 3. AN2728 Ointment B
2%, administered once daily
Drug: AN2728
Ointment B, 2% or 0.5% applied once or twice daily
Active Comparator: 4. AN2728 Ointment B
0.5%, administered twice daily
Drug: AN2728
Ointment B, 2% or 0.5% applied once or twice daily
Active Comparator: 5. AN2728 Ointment B
0.5%, administered once daily
Drug: AN2728
Ointment B, 2% or 0.5% applied once or twice daily

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01029405

Locations
Mexico
Mexico City, D.f., Mexico
Zapopan, Jalisco, Mexico
Monterrey, Nuevo Leon, Mexico
Monterrey, Nuevo León, Mexico
Chihuahua, Mexico
San Luis Potosí, Mexico
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01029405     History of Changes
Other Study ID Numbers: AN2728-PSR-203
C3291016 ( Other Identifier: Pfizer )
Study First Received: December 7, 2009
Results First Received: January 12, 2017
Last Updated: January 12, 2017

Keywords provided by Pfizer:
Topical
Plaque type psoriasis

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on May 25, 2017