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

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ClinicalTrials.gov Identifier: NCT01029405
Recruitment Status : Completed
First Posted : December 10, 2009
Results First Posted : March 7, 2017
Last Update Posted : March 7, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE December 7, 2009
First Posted Date  ICMJE December 10, 2009
Results First Submitted Date  ICMJE January 12, 2017
Results First Posted Date  ICMJE March 7, 2017
Last Update Posted Date March 7, 2017
Study Start Date  ICMJE November 2009
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 12, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 8, 2009)
Overall Target Plaque Severity Assessment (OTPSS) [ Time Frame: 6 weeks ]
Change History Complete list of historical versions of study NCT01029405 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 12, 2017)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 8, 2009)
To investigate a dose response in OTPSS across the four treatment groups [ Time Frame: 6 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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, 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
  • Drug: AN2728
    Ointment B, 2% or 0.5% applied once or twice daily
  • Drug: Placebo
    Ointment B Vehicle applied once or twice daily
Study Arms  ICMJE
  • Active Comparator: 1. AN2728 Ointment B
    2%, administered twice daily
    Intervention: Drug: AN2728
  • Placebo Comparator: 2. AN2728 Ointment B Vehicle
    Intervention: Drug: Placebo
  • Active Comparator: 3. AN2728 Ointment B
    2%, administered once daily
    Intervention: Drug: AN2728
  • Active Comparator: 4. AN2728 Ointment B
    0.5%, administered twice daily
    Intervention: Drug: AN2728
  • Active Comparator: 5. AN2728 Ointment B
    0.5%, administered once daily
    Intervention: Drug: AN2728
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
 (submitted: June 22, 2010)
145
Original Estimated Enrollment  ICMJE
 (submitted: December 8, 2009)
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:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Study Director: Pfizer CT.gov Call Center Pfizer
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