Efficacy and Safety of Enstilar Foam in Combination With Apremilast (Otezla) in Patients With Moderate Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Enstilar; Vehicle; Otezla
Intervention description: Enstilar foam applied to affected areas daily; vehicle foam applied to affected areas once daily; Otezla 30mg
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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 28.0
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 with Otezla in
      the treatment of patients with moderate plaque type psoriasis. Subjects will be randomized to
      study treatment at a 1:1 ratio of Otezla plus Enstilar foam versus Otezla plus vehicle foam.
    

Eligibility criteria:

        Inclusion Criteria:

        I. Outpatient, male or female subjects of any race, 18 years of age or higher. Female
        subjects of childbearing potential must have a (-)UPT (urine pregnancy test) result at
        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 of age, without a uterus and/or both ovaries; or has been
        surgically sterile for ≥ 6 moths.

        Reliable methods of contraception are:

        - hormonal methods or IUD (intrauterine device) 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 CBP (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.] ii. Subjects with moderate plaque type psoriasis who have been started on
        commercial Otezla within the last 10 days.

        iii. Physician Global Assessment (PGA) score of 3. iv. Able to understand study
        requirements and sign Informed Consent/HIPAA forms.

        Exclusion Criteria:

        I. 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.

        ii. History of hypercalcemia or vitamin D toxicity or history of significant renal or
        hepatic disease iii. Patients with guttate, erythrodermic, or pustular psoriasis iv.
        Serious skin condition (other than psoriasis) or uncontrolled medical condition (in the
        opinion of the investigator).

        v. Skin conditions (e.g.eczema) other than psoriasis that may interfere with evaluations of
        psoriasis.

        vi. Known hypersensitivity to Enstilar Foam or any of its components. vii. Current drug or
        alcohol abuse (Investigator opinion). viii. Subject unable to commit to all the assessments
        required by the protocol. ix. 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 Visit.