Olux E Foam and Sorilux Foam Combination Therapy for the Maintenance of Treatment Response in Patients With Moderate Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: vehicle foam; calcipotriene; calcipotriene + clobetasol propionate
Intervention description: clobetasol propionate 0.05% twice a day for two weeks; then vehicle foam twice a day every day for 8 weeks; clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day every day for 8 weeks; clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day on weekdays + clobetasol propionate 0.05% foam twice a day on weekends for 8 weeks
Intervention MeSH terms: Calcitriol; Clobetasol; Calcipotriene
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Olux E foam; Sorilux foam

Summary:

      The purpose of the study is to investigate if combined use of OLUX-E™ Foam and SORILUX Foam
      may help "maintain" the therapeutic benefit that is achieved with OLUX-E™ Foam in the
      treatment of moderate plaque psoriasis.

      OLUX-E™ is a medication that contains a corticosteroid delivered in a foam formulation.
      SORILUX Foam is a foam formulation of calcipotriene. Both medications have been approved by
      the FDA for treating plaque psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Outpatient, male or female subjects of any race, 18 years of age or higher. -Female
             subjects of childbearing potential must have a negative urine pregnancy test within 7
             days prior to the first dose of study drug and practice a reliable method of
             contraception throughout the study [Exception: Female subjects of child bearing
             potential who are not sexually active are not required to practice a reliable method
             of contraception and may be enrolled at the Investigator's discretion provided they
             are counseled to remain sexually inactive for the duration of the study and understand
             the risks involved in getting pregnant during the study.]

          -  Moderate plaque type psoriasis eligible for topical therapies.

          -  A Bod Surface Area (BSA) of 3-10%.

          -  Physician Global Assessment(PGA) score of 3.

          -  Able to understand study requirements and sign Informed Consent/Health Insurance
             Portability and Accountability Act forms.

        Exclusion Criteria:

          -  Female subjects who are pregnant, breast-feeding, or who are of childbearing potential
             and not practicing a reliable method of birth control, or male subjects planning a
             pregnancy with their spouse or partner while in the study.

          -  History of hypocalcaemia or vitamin D toxicity.

          -  Serious skin condition (other than psoriasis) or uncontrolled medical condition (in
             the opinion of the investigator).

          -  Topical steroids, topical immunomodulators, topical vitamin D derivatives, tar,
             salicylic acid, anthralin or any other topical treatment for psoriasis within 2 weeks
             of baseline.

          -  Use of any biologics within 3 months of baseline.

          -  Use of other systemic psoriasis treatments (ie, oral retinoids, methotrexate,
             cyclosporine, or other immunomodulators) within 4 weeks of baseline.

          -  Use of Ultraviolet B light (UVB) or oral psoralen with ultraviolet A (PUVA) within 2
             weeks of baseline.

          -  Skin conditions (e.g. eczema) psoriasis that may interfere with evaluations of
             psoriasis.

          -  Known hypersensitivity to Sorilux Foam Ointment or any of its components.

          -  Known hypersensitivity to Olux E Foam or any of its components.

          -  Contraindications according to the Sorilux Foam or Olux E Foam package inserts.

          -  Current drug or alcohol abuse (Investigator opinion).

          -  Subject unable to commit to all the assessments required by the protocol.

          -  Current enrollment in another clinical study and treatment with another experimental
             drug or approved therapy for experimental use within 30 days prior to the Screening