Back to resultsAN2728 Topical Ointment to Treat Mild-to-Moderate Plaque-Type Psoriasis
Primary Purpose
Psoriasis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AN2728 ointment, 2%
Ointment Vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis focused on measuring psoriasis
Eligibility Criteria
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
Sites / Locations
- The Savin Center
- Dermatology Specialists, PSC
- Minnesota Clinical Study Center
- Karl G. Heine, MD Dermatology
- Academic Dermatology Associates
- Dermatology Consulting Services
- Oregon Medical Research Center
- DermResearch, Inc
- J&S Studies, Inc.
- The Center for Skin Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
AN2728 ointment, 2%
Ointment Vehicle
Arm Description
AN2728 ointment, 2%
Ointment Vehicle
Outcomes
Primary Outcome Measures
Percentage of Participants Who Achieved Success in Physician's Global Assessment (PGA) of Disease Severity at 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.
Secondary Outcome Measures
Percentage of Participants Who Achieved Success in Physician's Global Assessment (PGA) of Disease Severity at Days 14, 28, 42, 56, and 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
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)
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
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
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01300052
Brief Title
AN2728 Topical Ointment to Treat Mild-to-Moderate Plaque-Type Psoriasis
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
January 26, 2011 (Actual)
Primary Completion Date
June 6, 2011 (Actual)
Study Completion Date
June 6, 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AN2728 ointment, 2%
Arm Type
Experimental
Arm Description
AN2728 ointment, 2%
Arm Title
Ointment Vehicle
Arm Type
Placebo Comparator
Arm Description
Ointment Vehicle
Intervention Type
Drug
Intervention Name(s)
AN2728 ointment, 2%
Intervention Description
AN2728 ointment, 2%, applied twice daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Ointment Vehicle
Intervention Description
Ointment Vehicle, applied twice daily for 12 weeks
Primary Outcome Measure Information:
Title
Percentage of Participants Who Achieved Success in Physician's Global Assessment (PGA) of Disease Severity at Day 84
Description
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.
Time Frame
Day 84
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Achieved Success in Physician's Global Assessment (PGA) of Disease Severity at Days 14, 28, 42, 56, and 70
Description
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.
Time Frame
Day 14, Day 28, Day 42, Day 56, Day 70
Title
Change From Baseline in Percentage of Body Surface Area (%BSA) Involved With Psoriasis at Day 84
Description
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.
Time Frame
Baseline (Day 1), Day 84
Title
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
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.
Time Frame
Baseline (Day 1) up to Day 84
Title
Number of Treatment-Emergent Adverse Events (TEAEs) by Severity
Description
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.
Time Frame
Baseline (Day 1) up to Day 84
Title
Number of Participants With Local Tolerability Symptoms: Burning/Stinging
Description
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.
Time Frame
Baseline (Day 1) up to Day 84
Title
Number of Participants With Local Tolerability Symptoms: Pruritus
Description
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.
Time Frame
Baseline (Day 1) up to Day 84
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
The Savin Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
Dermatology Specialists, PSC
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Minnesota Clinical Study Center
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432-3133
Country
United States
Facility Name
Karl G. Heine, MD Dermatology
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Academic Dermatology Associates
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Dermatology Consulting Services
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Oregon Medical Research Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Facility Name
DermResearch, Inc
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
J&S Studies, Inc.
City
College Station
State/Province
Texas
ZIP/Postal Code
77845
Country
United States
Facility Name
The Center for Skin Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77056
Country
United States
12. IPD Sharing Statement
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AN2728 Topical Ointment to Treat Mild-to-Moderate Plaque-Type Psoriasis
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