Patient Satisfaction Following Twice Daily Dosing With DFD-01 in Subjects With Moderate Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: DFD-01 (betamethasone dipropionate) Spray, 0.05%
Intervention description: DFD-01 (betamethasone dipropionate) Spray, 0.05% to be applied twice daily on the affected areas (avoiding the face, scalp, groin, axillae and other intertriginous areas) for 28 days.
Intervention MeSH terms: Betamethasone; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Betamethasone benzoate; Betamethasone sodium phosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess clinical response and patient satisfaction when DFD-01
      is used topically twice a day for moderate plaque psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patient understands the study procedures and agrees to participate by giving written
             informed consent. Patients must be willing to authorize use and disclosure of
             protected health information collected for the study.

          2. Patient must be at least 18 years of age.

          3. Patient must present with a clinical diagnosis of stable (at least 3 months)
             plaque-type psoriasis.

          4. At least 3% Body Surface Area involved, not including the face, scalp, groin, axillae
             and other intertriginous areas.

          5. Female patients of childbearing potential must agree to use contraception during the
             study which can include abstinence with an adequate secondary option should the
             patient become sexually active. A female is considered of childbearing potential
             unless she is:

               1. Postmenopausal for at least 12 months prior to study product administration;

               2. Without a uterus and/or both ovaries; or has been surgically sterile (i.e., tubal
                  ligation) for at least 6 months prior to study product administration.

             Reliable methods of contraception are:

               1. Hormonal methods or intrauterine device in use > 90 days prior to study product
                  administration; or

               2. Barrier methods plus spermicide in use at least 14 days prior to study product
                  administration.

               3. Partner has had a vasectomy at least 3 months previous to study product
                  administration.

               4. Essure® that has been in place for at least 3 months before the screening visit
                  with radiograph confirmation of fallopian tube blockage.

             Exception: Sexually inactive female patients of childbearing potential are not
             required to practice a reliable method of contraception and may be enrolled at the
             Investigator's discretion provided that they are counseled to remain sexually inactive
             for the duration of the study and understand the possible risks involved in getting
             pregnant during the study. An abstinent female must agree that if she becomes sexually
             active during the study she will use an acceptable form of contraception.

             All women must complete a urine pregnancy test at the Baseline Visit (Day 1) and the
             test result must be negative to be eligible for enrollment.

          6. Patient must be in good general health as determined by the investigator and supported
             by the medical history and normal or not clinically significant abnormal vital signs
             (temperature, blood pressure and pulse).

          7. Patient is physically able to apply study product to all affected areas or can obtain
             help.

        Exclusion Criteria:

          1. Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic,
             exfoliative or pustular psoriasis.

          2. Other inflammatory skin disease that may confound the evaluation of the plaque
             psoriasis (e.g., atopic dermatitis, contact dermatitis, tinea corporis).

          3. Presence of pigmentation, extensive scarring, pigmented lesions, tattoos or sunburn
             that could interfere with the rating of efficacy parameters.

          4. History of psoriasis unresponsive to topical treatments.

          5. History of organ transplant requiring immunosuppression, HIV, or other
             immunocompromised state.

          6. Ongoing infection (including viral lesions of the skin, fungal or bacterial skin
             infections, ulcers or wounds) or evidence of chronic infectious disease, history of or
             current 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.

          7. Use within 180 days before Baseline Visit of biologic treatment for psoriasis (e.g.,
             infliximab, adalimumab, etanercept, ustekinumab, secukinumab, or alefacept).

          8. Have received treatment for any type of cancer within 5 years of the Baseline Visit,
             except skin cancer and cervical cancer (in situ) that are allowed if at least 1 year
             before the Baseline Visit.

          9. Use within 60 days before the Baseline Visit of: 1) systemic or topical
             immunosuppressive drugs (e.g., tacrolimus, pimecrolimus), 2) systemic antipsoriatic
             treatment (e.g., methotrexate, cyclosporine, hydroxyurea) or 3) oral retinoids (e.g.,
             acitretin, isotretinoin).

         10. Use within 30 days before the Baseline Visit of: 1) systemic corticosteroids, 2)
             Ultraviolet light therapy, or 3) systemic anti-inflammatory agents* (e.g.,
             mycophenolate mofetil, sulfasalazine, 6-thioguanine). * Over-the-counter strength
             non-steroidal anti-inflammatory drugs used for transitional and common aches are
             permitted during the study.

         11. Use within 14 days before 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.

         12. History of unresolved or current hypothalamic-pituitary-adrenal suppression or
             significant endocrine disorder (Cushing's disease or Addison's disease) or
             uncontrolled diabetes.

         13. Patients who have participated in a study of an investigational drug 30 days before
             the Baseline Visit.

         14. Patients unable to comply with study requirements.

         15. Female patients who are pregnant (or planning to become pregnant) or breast-feeding.

         16. History of drug or alcohol abuse within the last year.

         17. Planned use of a tanning bed during the study.