A Double-Blind, Randomized, 12 Week, Bilateral Study of the Safety and Efficacy of AN2728 Ointment, 5%, Versus Ointment Vehicle in the Treatment of Patients With Plaque Type Psoriasis
Overview
- Phase
- Phase 2
- Intervention
- AN2728
- Conditions
- Psoriasis
- Sponsor
- Pfizer
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Percentage of Participants With Lowering of Overall Target Plaque Severity Score (OTPSS) at Day 84
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of AN2728 Ointment, 5%, compared to Ointment Vehicle, applied twice daily for 12 weeks, in the treatment of plaque type psoriasis
Detailed Description
This is a single center, randomized, double-blind, vehicle-controlled, bilateral design. Patients will apply both test articles, AN2728 Ointment, 5%, and Ointment 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female \>18 years of age at time of enrollment
- •The clinical diagnosis of stable plaque psoriasis
- •Two target plaques of similar severity
- •≥ 5 cm2 but ≤ 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 distinct plaques located on the trunk. Plaques located on the trunk must be separated by at least 10 cm and will be designated by the Investigator as either left/right or front/back or upper/lower
- •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 individual plaques
- •Normal or not clinically significant screening laboratory results
- •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 that could interfere with clinical evaluations or any disease state or physical condition which 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).
- •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 or surgically sterile (oophorectomy).
- •Washout periods of:
- •Topical drugs that might alter the course of psoriasis: 2 weeks
- •Oral retinoids: 8 weeks
- •Non-retinoid systemic drugs that might alter the course of psoriasis: 4 weeks
Arms & Interventions
1
AN2728 Ointment, 5%
Intervention: AN2728
2
AN2728 Ointment vehicle
Intervention: Ointment vehicle
Outcomes
Primary Outcomes
Percentage of Participants With Lowering of Overall Target Plaque Severity Score (OTPSS) at Day 84
Time Frame: Day 84
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 indicated more severity of a plaque. In this outcome measure, percentage of participants with reduced OTPSS at Day 84 were reported and comparison of ointment and vehicle treated plaque was given as 'Ointment treated plaque versus (vs.) vehicle treated plaque' and 'Vehicle treated plaque vs. ointment treated plaque'.
Secondary Outcomes
- Percentage of Participants With Lowering of Overall Target Plaque Severity Score (OTPSS) At Day 7, 14, 28, 42, 56, 70, 91(Day 7, 14, 28, 42, 56, 70, 91)