A Comparison of DFD01 Spray Versus Vehicle Spray in Subjects With Moderate Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: DFD01 Spray; Vehicle Spray
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 277.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objectives of this study are to compare the efficacy and safety of DFD01 Spray to Vehicle
      Spray for topical treatment of moderate plaque psoriasis
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects must present with a clinical diagnosis of stable (at least 3 months) plaque-type
        psoriasis.

        Subjects with psoriasis involving 10 to 20% BSA, not including the face, scalp, groin,
        axillae and other intertriginous areas.

        Subjects must have an IGA grade of 3 (moderate) at the Baseline Visit

        Exclusion Criteria:

        Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic,
        exfoliative or pustular psoriasis Other inflammatory skin disease that may confound the
        evaluation of the plaque psoriasis (e.g., atopic dermatitis, contact dermatitis, tinea
        corporis).

        Presence of pigmentation, extensive scarring, or pigmented lesions or sunburn which could
        interfere with the rating of efficacy parameters.

        History of psoriasis unresponsive to topical treatments. History of organ transplant
        requiring immunosuppression, HIV, or other immunocompromised state.

        Use within 180 days prior to Baseline Visit of biologic treatment for psoriasis (e.g.,
        infliximab, adalimumab, etanercept, ustekinumab, or alefacept).

        Have received treatment for any type of cancer within 5 years of the Baseline Visit except
        skin cancer and cervical cancer (in situ) are allowed within 1 year of the Baseline Visit.

        Use within 60 days prior to the Baseline Visit of: 1) immunosuppressive drugs (e.g.,
        tacrolimus, pimecrolimus), 2) systemic antipsoriatic treatment (e.g., methotrexate,
        cyclosporine, hydroxyurea) or 3) oral retinoids (e.g., acitretin, isotretinoin).

        Use within 30 days prior to the Baseline Visit of: 1) systemic steroids, 2) PUVA therapy,
        3) systemic anti-inflammatory agents (e.g., mycophenolate mofetil, sulfasalazine,
        6-thioguanine), or 4) UVB therapy. Inhaled, intraocular, and intranasal steroids are
        allowed.

        Use within 14 days prior to the Baseline Visit of: 1) topical antipsoriatic drugs (e.g.,
        salicylic acid, anthralin, coal tar, calcipotriene), 2) topical retinoids (e.g.,
        tazarotene, tretinoin) or 3) topical corticosteroids.

        Require use of beta blockers, lithium, ACE inhibitors, and/or NSAIDs (indomethacin,
        ibuprofen, aspirin, naproxen) with a medical history that these medications affect the
        subject's psoriasis, except if the subject has been using the medication routinely during
        the 180 days prior to the Baseline Visit, these medications are allowed.