Desoximetasone Spray 0.25%, Hypothalamic Pituitary Adrenal (HPA) Axis Study
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Desoximetasone 0.25% spray
Intervention description: Desoximetasone spray applied to affected areas twice daily for 28 days
Intervention MeSH terms: Desoximetasone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Plaque psoriasis

Summary:

      The objective of this study is to evaluate the potential of desoximetasone 0.25% topical
      spray to suppress HPA axis function. The potential for adrenal suppression will be assessed
      following multiple dosing with Desoximetasone 0.25% Topical Spray in patients with moderate
      to severe plaque psoriasis. The secondary objectives are to evaluate the efficacy parameters
      and to evaluate the adverse event (AE) profile.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a definite clinical diagnosis of stable plaque psoriasis with the extent of BSA
             affected as designated for each group

          -  Group 1: involvement of 10-15% of their BSA

          -  Group 2: involvement of > 15% of their BSA

          -  Have a Physicians Global Assessment (PGA) score of 3 (moderate) or 4 (severe) at
             baseline for the overall disease severity.

          -  Results from a cortisol response test that are considered normal and show no evidence
             of any abnormal HPA function or adrenal response. Patients must fulfill all of these
             stipulations:

        Exclusion Criteria:

          -  Female who is pregnant, nursing, planning to become pregnant during the duration of
             the study, or if of child bearing potential and sexually active not prepared to use
             appropriate contraceptive methods to avoid pregnancy.

          -  Patient has current diagnosis of types of psoriasis other than stable plaque psoriasis
             (i.e. acute, guttate, erythrodermic, exfoliative or pustular psoriasis) or has
             psoriasis of any kind on the face or scalp that will require active treatment during
             the study.

          -  Patient has a history of psoriasis that has been unresponsive to topical
             corticosteroid therapy.

          -  In the Investigator's opinion, the patient has other dermatological conditions, such
             as atopic or contact dermatitis, that may interfere with the clinical assessments of
             the signs and symptoms of psoriasis

          -  Patient has a history of allergy or sensitivity to corticosteroids or history of any
             drug hypersensitivity or intolerance which, in the opinion of the Investigator, would
             compromise the safety of the patient or the results of the study.

          -  Patient has a history of an adverse reaction to CortrosynTM or similar test reagents.

          -  Patient has a significant history or current evidence of chronic infectious disease,
             system disorder, organ disorder or other medical condition that in the Investigator's
             opinion would place the study patient at undue risk by participation in the study.

          -  Patient is currently receiving or has received any radiation therapy, anti-neoplastic
             agents or immunosuppressant medication within 4 weeks prior to the first dose of study
             drug.

          -  Patient has undergone treatment with any systemic or photo antipsoriatic therapy
             within 8 weeks of the first dose of study drug.

          -  Patient has been treated within 12 weeks (or five half lives whichever is less) prior
             to the first dose of study drug with any biological therapies for psoriasis.

          -  Patient has received any systemic steroids within 4 weeks of the first dose of the
             study drug.

          -  Patients who have used any topical antipsoriatic agents of any kind or any topical
             corticosteroids for any reason within 2 weeks prior to first use of study drug