AN2728 Topical Ointment to Treat Mild-to-Moderate Plaque-Type Psoriasis - Full Text View

Purpose

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.

Condition	Intervention	Phase
Psoriasis	Drug: AN2728 ointment, 2% Drug: Ointment Vehicle	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Participant, Care Provider, Investigator, Outcomes Assessor Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis

Drug Information available for: Crisaborole

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

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.

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 [ 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.


Enrollment:	68
Actual Study Start Date:	January 26, 2011
Study Completion Date:	June 6, 2011
Primary Completion Date:	June 6, 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: AN2728 ointment, 2% AN2728 ointment, 2%	Drug: AN2728 ointment, 2% AN2728 ointment, 2%, applied twice daily for 12 weeks
Placebo Comparator: Ointment Vehicle Ointment Vehicle	Drug: Ointment Vehicle Ointment Vehicle, applied twice daily for 12 weeks

Eligibility


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

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

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: NCT01300052

Locations


United States, Connecticut
The Savin Center
New Haven, Connecticut, United States, 06511
United States, Kentucky
Dermatology Specialists, PSC
Louisville, Kentucky, United States, 40202
United States, Minnesota
Minnesota Clinical Study Center
Fridley, Minnesota, United States, 55432-3133
United States, Nevada
Karl G. Heine, MD Dermatology
Henderson, Nevada, United States, 89052
United States, New Mexico
Academic Dermatology Associates
Albuquerque, New Mexico, United States, 87106
United States, North Carolina
Dermatology Consulting Services
High Point, North Carolina, United States, 27262
United States, Oregon
Oregon Medical Research Center
Portland, Oregon, United States, 97223
United States, Texas
DermResearch, Inc
Austin, Texas, United States, 78759
J&S Studies, Inc.
College Station, Texas, United States, 77845
The Center for Skin Research
Houston, Texas, United States, 77056

Sponsors and Collaborators

Pfizer

Investigators


Study Director:	Pfizer Pfizer CT.gov Call Center	Pfizer

More Information


Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT01300052 History of Changes
Other Study ID Numbers:	AN2728-PSR-204 C3291017 ( Other Identifier: Alias Study Number )
Study First Received:	February 17, 2011
Results First Received:	January 12, 2017
Last Updated:	March 17, 2017

Keywords provided by Pfizer:


psoriasis

Additional relevant MeSH terms:


Psoriasis Skin Diseases, Papulosquamous Skin Diseases

ClinicalTrials.gov processed this record on July 17, 2017