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

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer

Criteria

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