The Effect of Enstilar Versus Vehicle on Target Lesions in Moderate Plaque Type Psoriasis Patients
Condition: Plaque Psoriasis
MeSH terms: Psoriasis; Erythema Multiforme
Intervention: Enstilar
Intervention description: Enstilar foam applied to affected area once daily
Intervention MeSH terms: Betamethasone; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Betamethasone benzoate; Calcipotriene; Betamethasone sodium phosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study seeks to show whether there is a benefit of prescribing Enstilar in the treatment
      of patients with moderate plaque type psoriasis. Subjects will receive study treatment of
      Enstilar foam.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Outpatient, male or female subjects of any race, 18 years of age or higher. Female
             subjects of childbearing potential must have a (-) urine pregnancy test (UPT) result
             within 7 days of the first dose of study drug and practice a reliable method of
             contraception throughout the study.

             A female is considered of childbearing potential unless she is:

             - postmenopausal >5 years, without a uterus and/or both ovaries, or has been
             surgically sterile for >6 months

             Reliable methods of contraception are:

             - hormonal methods or intrauterine device (IUD) in use > 90 days prior to study drug
             administration, barrier methods plus spermicide in use > 14 days prior, or
             vasectomized partner.

             [Exception: Female subjects of child bearing potential (CBP) 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 counselled to remain
             sexually inactive for the duration of the study and understand the risks involved in
             getting pregnant during the study.]

          2. Moderate plaque type psoriasis eligible for topical therapies.

          3. Patients with a minimum of 3% BSA to a maximum of 20% BSA & bilateral symmetric
             psoriatic plaques of 2 to 4 cm in diameter.

          4. Physician Global Assessment (PGA) score of 3.

          5. Able to understand study requirements and sign Informed Consent/HIPAA forms.

             -

        Exclusion Criteria:

          1. 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.

          2. History of hypercalcaemia or vitamin D toxicity.

          3. Patients with guttate, erythrodermic, or pustular psoriasis

          4. Serious skin condition (other than psoriasis) or uncontrolled medical condition (in
             the opinion of the investigator.)

          5. Topical steroids, topical immunomodulators, topical vitamin D derivatives, tar,
             salicylic acid, anthralin or any other topical treatment for psoriasis within 2 weeks
             of baseline.

          6. Use of any biologics within 3 months of baseline.

          7. Use of other systemic psoriasis treatments (ie, oral retinoids, methotrexate,
             cyclosporine, or other immunomodulators) within 4 weeks of baseline.

          8. Use of ultraviolet B rays (UVB) or psoralen+ultraviolet a rays (PUVA) within 2 weeks
             of baseline.

          9. Skin conditions (e.g. eczema) other than psoriasis that may interfere with evaluations
             of psoriasis.

         10. Known hypersensitivity to Enstilar or any of its components.

         11. Contraindications according to Enstilar.

         12. Current drug or alcohol abuse (Investigator opinion.)

         13. Subject unable to commit to all the assessments required by protocol. -