Desoximetasone Spray 0.05%, 0.25%; Dose Ranging Study
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Desoximetasone 0.05% once daily; Desoximetasone 0.05% twice daily; Desoximetasone 0.25% once daily; Desoximetasone 0.25% once daily; Vehicle once daily; Vehicle twice daily
Intervention description: Desoximetasone topical spray 0.05% administered to affected area once daily for 28 days; Desoximetasone topical spray 0.05% administered to affected area twice daily for 28 days; Desoximetasone topical spray 0.25% administered to affected area once daily for 28 days; Desoximetasone topical spray 0.25% administered to affected areas twice daily for 28 days; Vehicle topical spray administered to affected areas once daily for 28 days; Vehicle topical spray administered to affected areas twice daily for 28 days
Intervention MeSH terms: Desoximetasone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 151.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Psoriasis; Topical corticosteroids; Plaque psoriasis

Summary:

      The objectives of this study are to evaluate the efficacy and safety of two dosing regimens
      of desoximetasone 0.05% and 0.25% topical sprays as compared to a vehicle spray in patients
      with moderate to severe plaque psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a definite clinical diagnosis of stable plaque psoriasis involving ≥ 10% of the
             body surface area (BSA).

          -  Have a combined total lesion severity score (TLSS) of ≥ 7 for the target lesion.

          -  Have a plaque elevation score ≥ 3 of (moderate) for the target lesion.

          -  The target lesion must have an area of at least 5 cm².

          -  Have a Physicians Global Assessment (PGA) score of 3 (moderate) or 4 (severe) at
             baseline for the overall disease severity.

        Exclusion Criteria:

          -  Pregnancy

          -  Current diagnosis of other types of psoriasis other than stable plaque psoriasis or
             has psoriasis of any kind of the face or scalp that will require active treatment
             during the study.

          -  History of psoriasis that has been unresponsive to topical corticosteroid therapy.

          -  Dermatological conditions that may interfere with the clinical assessments of the
             signs and symptoms of psoriasis.

          -  Allergy or sensitivity to corticosteroids or history of any drug hypersensitivity or
             intolerance which would compromise the safety of the patient or the results of the
             study.

          -  Any condition that would place the study patient at undue risk by participation in the
             study.

          -  Radiation therapy, antineoplastic agents or immunosuppressant medication within 4
             weeks prior to the first dose of study drug.

          -  Treatment with any systemic or photo antipsoriatic therapy, within 8 weeks of the
             first dose of study drug.

          -  Treatment within 12 weeks (or five half lives, whichever is less) prior to the first
             dose of study drug with any biological therapies for psoriasis.

          -  Systemic steroids within 4 weeks of the first dose of the study drug. The use of
             inhaled or intranasal corticosteroids is acceptable as long as usage has been stable
             for at least 2 weeks prior to the first dose of study drug and will be continued
             during the study.

          -  Hormonal contraceptives for less than one complete cycle prior to entering the study.

          -  Topical antipsoriatic agents of any kind or any topical corticosteroids for any reason
             within 2 weeks prior to first use of study drug. Nonprescription antipsoriatic
             shampoos used only on the scalp will be allowed during the study.

          -  Receipt of any drug as part of a research study within 30 days prior to first dosing.