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AN2728 Topical Ointment to Treat Mild-to-Moderate Plaque-Type Psoriasis

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ClinicalTrials.gov Identifier: NCT01300052
Recruitment Status : Completed
First Posted : February 21, 2011
Results First Posted : March 7, 2017
Last Update Posted : April 17, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE February 17, 2011
First Posted Date  ICMJE February 21, 2011
Results First Submitted Date  ICMJE January 12, 2017
Results First Posted Date  ICMJE March 7, 2017
Last Update Posted Date April 17, 2017
Actual Study Start Date  ICMJE January 26, 2011
Actual Primary Completion Date June 6, 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 12, 2017)
Percentage of Participants Who Achieved Success in Physician's Global Assessment (PGA) of Disease Severity at Day 84 [ Time Frame: Day 84 ]
PGA assessed severity of overall disease activity in participants. It was performed using a 6-point scale graded from 0 - 5, in which 0 = clear (no plaque elevation above normal skin level), 1 = almost clear (essentially flat with possible trace elevation), 2 = mild (slight but definite elevation of plaque above normal skin level), 3 = moderate (moderate elevation with rounded or sloped edges to plaque), 4 = severe (marked elevation with hard, sharp edges to plaque), 5 = very severe (very marked elevation with very hard, sharp edges to plaque). The success in PGA of disease severity was defined as a PGA score of '0 = clear' or '1 = almost clear', with at least 2-grade improvement in PGA from Baseline to Day 84.
Original Primary Outcome Measures  ICMJE
 (submitted: February 17, 2011)
Proportion of subjects achieving success in Physician's Global Assessment (PGA) of disease severity, defined as a PGA of 'Clear' or 'Almost Clear', with at least a 2-grade improvement from baseline at Day 84 [ Time Frame: Day 84 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 12, 2017)
  • Percentage of Participants Who Achieved Success in Physician's Global Assessment (PGA) of Disease Severity at Days 14, 28, 42, 56, and 70 [ Time Frame: Day 14, Day 28, Day 42, Day 56, Day 70 ]
    PGA assessed severity of overall disease activity in participants. It was performed using a 6-point scale graded from 0 - 5, in which 0 = clear (no plaque elevation above normal skin level), 1 = almost clear (essentially flat with possible trace elevation), 2 = mild (slight but definite elevation of plaque above normal skin level), 3 = moderate (moderate elevation with rounded or sloped edges to plaque), 4 = severe (marked elevation with hard, sharp edges to plaque), 5 = very severe (very marked elevation with very hard, sharp edges to plaque). The success in PGA of disease severity was defined as a PGA score of '0 = clear' or '1 = almost clear', with at least 2-grade improvement in PGA from Baseline to Day 14, 28, 42, 56 and 70.
  • Change From Baseline in Percentage of Body Surface Area (%BSA) Involved With Psoriasis at Day 84 [ Time Frame: Baseline (Day 1), Day 84 ]
    Percentage of the total body surface area (BSA) involved with psoriasis was measured. Change from Baseline (Day 1) in percentage of BSA at Day 84 was reported.
  • Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline (Day 1) up to Day 84 ]
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Day 84 that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAE and non-SAE.
  • Number of Treatment-Emergent Adverse Events (TEAEs) by Severity [ Time Frame: Baseline (Day 1) up to Day 84 ]
    An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs were classified according to the severity in 3 categories a) mild =AEs does not interfere with participant's usual function b) moderate =AEs interfered to some extent with participant's usual function c) severe =AEs interfered significantly with participant's usual function and required systemic drug therapy. Treatment-emergent were events between first dose of study drug and up to Day 84 that were absent before treatment or that worsened relative to pretreatment state. In this outcome measure, number of mild, moderate and severe TEAEs were reported.
  • Number of Participants With Local Tolerability Symptoms: Burning/Stinging [ Time Frame: Baseline (Day 1) up to Day 84 ]
    Local tolerability in participants was evaluated in terms of presence and absence of burning/stinging symptom and its severity in the areas of body where medication was applied. Burning/stinging symptoms were graded on a 4-point scale of 0 - 3 where 0 =none (no stinging/ burning), 1 =mild (slight warm, tingling sensation), 2 = moderate (definite warm; tingling/stinging sensation), 3 = severe (hot, tingling/stinging sensation that caused definite discomfort). Higher scores=Severe symptoms. In this outcome measure, number of participants with none, mild, moderate and severe burning/stinging symptoms were reported.
  • Number of Participants With Local Tolerability Symptoms: Pruritus [ Time Frame: Baseline (Day 1) up to Day 84 ]
    Local tolerability was evaluated in participants in terms of presence and absence of pruritus symptom and its severity in the areas of body where medication was applied. Pruritus symptoms were graded on a 4-point scale of 0 - 3 where 0 =none (no pruritus), 1 =mild (occasional, slight itching/scratching), 2 = moderate (constant or intermittent itching/scratching which was not disturbing sleep), 3 = severe (bothersome itching/scratching which was disturbing sleep). Higher scores=Severe symptoms. In this outcome measure, number of participants with none, mild, moderate and severe pruritus symptoms were reported.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 17, 2011)
  • Proportion of subjects achieving success in PGA at Days 14, 28, 42, 56, and 70 [ Time Frame: Days 14, 28, 42, 56, and 70 ]
  • Difference in the proportion of subjects achieving success in PGA between groups at Days 14, 28, 42, 56, 70, and 84 [ Time Frame: Days 14, 28, 42, 56, 70, and 84 ]
  • Change in Percent Body Surface Area (%BSA) involved with psoriasis (excluding face and scalp) from Baseline to Day 84 [ Time Frame: Day 84 ]
  • Frequency and severity of adverse events in subjects treated for up to 84 days [ Time Frame: Up to Day 84 ]
  • Local tolerability signs/symptoms in subjects treated for up to 84 days [ Time Frame: Up to day 84 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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
  • Drug: AN2728 ointment, 2%
    AN2728 ointment, 2%, applied twice daily for 12 weeks
  • Drug: Ointment Vehicle
    Ointment Vehicle, applied twice daily for 12 weeks
Study Arms  ICMJE
  • Experimental: AN2728 ointment, 2%
    AN2728 ointment, 2%
    Intervention: Drug: AN2728 ointment, 2%
  • Placebo Comparator: Ointment Vehicle
    Ointment Vehicle
    Intervention: Drug: Ointment Vehicle
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: October 20, 2011)
68
Original Estimated Enrollment  ICMJE
 (submitted: February 17, 2011)
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:

  • 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

Exclusion Criteria:

  • 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
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 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
Study Director: Pfizer Pfizer CT.gov Call Center Pfizer
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