Safety and Efficacy Study of A Novel Ointment to Treat Plaque Type Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: AN2728; Ointment vehicle
Intervention description: AN2728 Ointment, 5%, twice daily for 12 weeks; Ointment vehicle, twice daily for 12 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Plaque Type Psoriasis; Topical

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
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female >18 years of age at time of enrollment

          2. The clinical diagnosis of stable plaque psoriasis

          3. 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

          4. Normal or not clinically significant screening laboratory results

          5. Willing and able to apply study drug as directed, comply with study instructions and
             commit to all follow-up visits

          6. Ability to understand, agree to and sign the study Informed Consent Form (ICF) prior
             to initiation of any protocol related procedures

        Exclusion Criteria:

          1. 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

          2. Any underlying disease(s) or other dermatological conditions that require the use of
             exclusionary topical or systemic therapy (see below).

          3. Known sensitivity to any of the components of the study medication

          4. Spontaneously improving or rapidly deteriorating psoriatic plaques or
             pustular/exfoliative, guttate, erythrodermic or other non-plaque form of psoriasis

          5. Concomitant use of topical or systemic therapies that might alter the course of
             psoriasis

          6. Females of child bearing potential. Females must be post-menopausal or surgically
             sterile (oophorectomy).

          7. 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

               -  PUVA: 4 weeks

               -  UVB therapy: 4 weeks

               -  Use of emollients/moisturizers on area(s) to be treated: 2 days to baseline visit

          8. AIDS or AIDS related illness

          9. Concurrent participation in another drug research study or within 30 days of
             enrollment

         10. Use of lithium or hydroxychloroquine containing products (i.e. Plaquenil)

         11. Use of a beta-blocking medication (i.e. propranolol) if the dose has not been
             stabilized for at least 3 months