Topical Psoriasis Study for Patients Receiving Biologic Therapy
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Topicort Topical Spray
Intervention description: open label Topicort spray
Intervention MeSH terms: Desoximetasone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Healthy volunteers: No

Summary:

      A two-phase, single center, study of 20 subjects to assess 4 weeks of add-on therapy of
      Topicort® BID and 12 weeks BID on two consecutive days a week to patients with ≤5% BSA who
      are receiving biologic therapy for at least 24 weeks
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female adults ≥ 18 years of age.

          2. Diagnosis of chronic plaque-type psoriasis.

          3. Able to give written informed consent prior to performance of any study related
             procedures.

          4. Treated with a biologic agent for a minimum of 24 weeks at baseline.

          5. Plaque-type psoriasis as defined at screening and baseline by BSA ≤ 5%.

          6. Females of childbearing potential (FCBP) must have a negative pregnancy test at
             Screening and Baseline. FCBP who engage in activity in which conception is possible
             must use one of the approved contraceptive options: hormonal contraception;
             intrauterine device (IUD); tubal ligation; or partner's vasectomy; Male or female
             condom diaphragm with spermicide, cervical cap with spermicide, or contraceptive
             sponge with spermicide.

          7. Subject must be in general good health (except for psoriasis) as judged by the
             Investigator, based on medical history, physical examination.

        Exclusion Criteria:

          1. >5% Body Surface Area

          2. Any condition, which would place the subject at unacceptable risk if he/she were to
             participate in the study.

          3. Pregnant or breast feeding, or considering becoming pregnant during the study.

          4. Malignancy or history of malignancy, except for:

               1. treated [ie, cured] basal cell or squamous cell in situ skin carcinomas;

               2. treated [ie, cured] malignancy with no evidence of recurrence within the previous
                  5 years.

          5. Use of any investigational drug within 4 weeks prior to randomization, or within 5
             pharmacokinetic/pharmacodynamic half lives, if known (whichever is longer).

          6. Use of oral systemic medications for the treatment of psoriasis within 4 weeks
             (includes, but not limited to, oral corticosteroids, methotrexate, acitretin,
             apremilast and cyclosporine).

          7. Patient used other topical therapies to treat within 2 weeks of the Baseline Visit
             (includes, but not limited to, topical corticosteroids, vitamin D analogs, or
             retinoids).

          8. Patient received UVB phototherapy within 2 weeks of Baseline.

          9. Patient received PUVA phototherapy within 4 weeks of Baseline.

         10. Patient has a known hypersensitivity to the excipients of Topicort Spray® as stated in
             the label.