Enstilar® Foam in the Treatment of Chronic Plaque Psoriasis in Patients With Skin of Color
Condition: Plaque Psoriasis; Psoriasis
MeSH terms: Psoriasis
Intervention: Enstilar® foam; Vehicle foam
Intervention description: for 4 weeks; for 4 weeks
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 4:1 Enstilar(R): placebo from baseline to week 4, then open-label Enstilar from weeks 4 to 8.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Double-blind, vehicle-controlled from week 0 to 4
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: skin of color; psoriasis; Enstilar; skin diseases

Summary:

      This will be a single-center, randomized, double-blinded, vehicle-controlled clinical study
      to determine the efficacy of Enstilar® foam, a combination of calcipotriene and betamethasone
      dipropionate 0.005%/0.064%, in the treatment of psoriasis vulgaris in skin of color (FST
      IV-VI). This study will also evaluate the degree of erythema versus hyperpigmentation in
      psoriasis plaques in skin of color (and its change with Enstilar ® treatment) as well as the
      effect of Enstilar ® on post-inflammatory hyperpigmentation and quality of life.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provide written, signed and dated informed consent prior to initiating any
             study-related activities.

          -  Male or female >18 years of age at the time of screening

          -  Fitzpatrick Skin phototype IV-VI, non-white race/ethnicity, including but not limited
             to - --African Americans, Asians, Pacific Islanders and Hispanics.

          -  Clinical diagnosis of chronic plaque-type psoriasis of the body

          -  Plaque psoriasis with ≥2% Body Surface Area (BSA) involvement (may include scalp
             involvement), PASI Score ≥ 2, IGA mod 2011 score of 2 or greater (based on scale of
             0-4)

          -  Females of childbearing potential (FCBP) must have a negative pregnancy test at
             Screening and Baseline. While using investigational product and for at least 28 days
             after last application of investigational product, FCBP who engage in activity in
             which conception is possible must use one of the approved contraceptive options d

          -  Must be in general good health as judged by the Investigator, based on medical history
             and physical examination.

        Exclusion Criteria:

          -  Form of diagnosed psoriasis other than chronic plaque psoriasis (i.e. guttate,
             erythrodermic, pustular)

          -  Diagnosis of other active, ongoing skin diseases or skin infections that may interfere
             with examination of psoriasis lesions

          -  Ongoing use of other psoriasis treatment including but not limited to topical or
             systemic corticosteroids, other topical medications (i.e. coal tar), oral or biologic
             medications for the treatment of psoriasis, and UV therapy. The following washout
             periods will be required: 2 weeks for topical therapy; 2 weeks for phototherapy; 12
             weeks for biologic or targeted therapies; 4 weeks for other systemic therapies

          -  Use of oral estrogen therapy, excluding oral contraceptive pills

          -  Women who are pregnant, nursing, or of child-bearing potential who are unwilling to
             use appropriate method(s) of contraception.

          -  Patients unwilling to limit exposure to UV light

          -  Current significant medical problems that, in the discretion of the investigator,
             would put the patient at significant risk

          -  Patients with disorders of calcium metabolism and/or hypercalcemia

          -  Use of any investigational drug within 4 weeks prior to randomization, or 5
             pharmacokinetic/pharmacodynamics half-lives, if known (whichever is longer)

          -  History of allergy to any component of the IP