Safety and Efficacy Study of DUR-928 Topical Solution in Subjects With Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: DUR-928 Topical Solution; Vehicle Topical Solution
Intervention description: Topical solution containing active drug; Topical solution containing no active drug
Intervention MeSH terms: Pharmaceutical Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This Phase 2 study has been designed to determine and compare the safety, tolerability, and
      efficacy of DUR-928 topical solution with that of the vehicle topical solution when applied
      once daily for approximately four weeks in subjects with plaque psoriasis. Subjects will be
      instructed (randomly assigned) to apply DUR-928 solution to a target lesion on one arm and
      vehicle solution to a target lesion on the opposite arm once daily for up to four weeks.
      Subjects will occlude the treated areas for approximately two hours after each application.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject is a male or non-pregnant female 18 years of age or older.

          2. Subject has provided written informed consent.

          3. Subject has a clinical diagnosis of stable mild to moderate plaque psoriasis for at
             least two months.

          4. Females must be post-menopausal, surgically sterile, or use an effective method of
             birth control. Women of childbearing potential (WOCBP) must have a negative urine
             pregnancy test (UPT) at Visit 2/Baseline.

          5. Males (or their female partner) must agree to use an effective method of birth control
             throughout the study.

          6. Subject has two similar contralateral Target Plaques.

          7. Subject is willing and able to apply the test article(s) as directed, comply with
             study instructions, and commit to all follow-up visits for the duration of the study.

          8. Subject, in the investigator's opinion, is in good general health and free of any
             disease state or physical condition that might impair evaluation of the plaque
             psoriasis or exposes the subject to an unacceptable risk by study participation.

        Exclusion Criteria:

          1. Subject is pregnant, lactating, or is planning to become pregnant during the study.

          2. Subject has spontaneously improving or rapidly deteriorating plaque psoriasis.

          3. Subject has guttate, pustular, erythrodermic, inverse, or other non-plaque forms of
             psoriasis.

          4. Subject has psoriasis beyond the two Target Plaques that, in the investigator's
             opinion, could not be reasonably managed with only a bland emollient during the study.

          5. Subject is currently enrolled in an investigational drug or device study.

          6. Subject has been previously enrolled in this study and treated with test article.

        Other protocol-defined inclusion and exclusion criteria assessed by the study staff may
        apply.