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

• Drug: AN2728
  
  Ointment B, 2% or 0.5% applied once or twice daily
• Drug: Placebo
  
  Ointment B Vehicle applied once or twice daily

• Active Comparator: 1. AN2728 Ointment B
  
  2%, administered twice daily
  Intervention: Drug: AN2728
• Placebo Comparator: 2. AN2728 Ointment B Vehicle
  
  Intervention: Drug: Placebo
• Active Comparator: 3. AN2728 Ointment B
  
  2%, administered once daily
  Intervention: Drug: AN2728
• Active Comparator: 4. AN2728 Ointment B
  
  0.5%, administered twice daily
  Intervention: Drug: AN2728
• Active Comparator: 5. AN2728 Ointment B
  
  0.5%, administered once daily
  Intervention: Drug: AN2728

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