Safety and Efficacy Study of A Novel Ointment to Treat Plaque Type Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: AN2728; AN2728 Ointment Vehicle
Intervention description: AN2728 Ointment, 5%, twice daily for 4 weeks; AN2728 Ointment Vehicle, twice daily for 4 weeks.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Plaque Type Psoriasis; Topical

Summary:

      The purpose of the study is to determine the safety and efficacy of AN2728 Ointment, 5%,
      compared to Ointment Vehicle 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

               1. ≥ 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.

               2. Bilaterally located (right/left) plaques on the arms or plaques located on the
                  upper and lower trunk. Plaques located on the trunk were to be separated by at
                  least 10 cm and designated by the Investigator as either left/right or
                  front/back.

               3. Target plaque severity score of 2-4 (mild to moderate).

          4. Normal or not clinically significant screening laboratory results.

          5. Subjects who were willing and able to apply study drug as directed, comply with study
             instructions, and commit to all follow-up visits.

          6. Subjects who had the 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 (based on FSH
             levels) or surgically sterile (oophorectomy)

          7. Washout periods of:

               1. Topical drugs that might alter the course of psoriasis: 2 weeks

               2. Oral retinoids: 8 weeks

               3. Non-retinoid systemic drugs that might alter the course of psoriasis: 4 weeks

               4. PUVA: 4 weeks

               5. UVB therapy: 4 weeks

               6. Use of emollients/moisturizers on area(s) to be treated: 2 days prior 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