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

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

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

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: AN2728; Drug: Placebo

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: Interventional
• Enrollment (Actual): 145
• Phase: Phase 2

Contacts and Locations

Study Locations

• Mexico
  • Chihuahua, Mexico
  • San Luis Potosí, Mexico
  • D.f.
    • Mexico City, D.f., Mexico
  • Jalisco
    • Zapopan, Jalisco, Mexico
  • Nuevo Leon
    • Monterrey, Nuevo Leon, Mexico
  • Nuevo León
    • Monterrey, Nuevo León, Mexico

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Greater Decrease In Overall Target Plaque Severity Score (OTPSS): Ointment (2% Twice Daily), Vehicle	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.	Day 42

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Greater Decrease In OTPSS: Ointment (0.5 % Once Daily, 0.5% Twice Daily and 2% Once Daily), Vehicle	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.	Day 42

Collaborators and Investigators

• Sponsor: Pfizer

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: December 7, 2009
• First Submitted That Met QC Criteria: December 8, 2009
• First Posted (Estimate): December 10, 2009

Study Record Updates

• Last Update Posted (Actual): March 7, 2017
• Last Update Submitted That Met QC Criteria: January 12, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Topical; Plaque type psoriasis
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: AN2728-PSR-203; C3291016 (Other Identifier: Pfizer)