Combination of Halobetasol Propionate and Tazarotene Lotion (Duobrii®) for Palmoplantar Plaque Type Psoriasis
Condition: Palmoplantar Psoriasis; Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Duobrii®
Intervention description: Duobrii® (halobetasol propionate 0.01%/tazarotene 0.045% lotion, HP/TAZ) will be provided at weeks 0,2,8,16 for a total of 24 weeks.
Intervention MeSH terms: Halobetasol; Tazarotene
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Palmoplantar; Psoriasis; Plaque

Summary:

      The purpose of this research study is to examine the effect of Duobrii® (halobetasol
      propionate 0.01%/tazarotene 0.045% lotion, HP/TAZ) on plaque type psoriasis of the hands
      and/or feet.
    

Eligibility criteria:

        Inclusion Criteria

          -  Subject is able to provide written, informed consent and comply with the study
             protocol.

          -  Subject is at least 18 years of age.

          -  Subject has a diagnosis of plaque-type palmar and/or plantar psoriasis.

          -  Patient has at least one psoriatic plaque outside of the palms and soles or psoriatic
             nail findings.

          -  Subject has a ppPGA ≥ 3 at screening/baseline visit.

          -  Subject is using adequate birth control during the study period as defined as follows:

               1. Option 1: Any one of the following highly effective methods: hormonal
                  contraception (oral, injection, implant, transdermal patch, vaginal ring);
                  intrauterine device (IUD); tubal ligation; or partner's vasectomy; OR

               2. Option 2: Male or female condom (latex condom or nonlatex condom NOT made out of
                  natural [animal] membrane [for example, polyurethane]; PLUS one additional
                  barrier method: (a) diaphragm with spermicide; (b) cervical cap with spermicide;
                  or (c) contraceptive sponge with spermicide.

                  OR

               3. Option 3: Abstinence from sex when it is a lifestyle choice, and not just a
                  social circumstance.

        Exclusion Criteria

          -  Subject is not able to provide written, informed consent and comply with the study
             protocol.

          -  Subject is less than 18 years of age.

          -  Subject has non-plaque type psoriasis on the hands and/or feet.

          -  Patient does not have any evidence of psoriasis elsewhere.

          -  Subject has concurrent cutaneous disease affecting the hands and/or feet that would
             interfere with assessments.

          -  Subject has a ppPGA < 3 at screening/baseline visit.

          -  Subject refuses to discontinue concomitant prescription medications on hands and/or
             feet.

          -  Subject has used topical prescription treatments or received phototherapy treatment
             for psoriasis within 2 weeks of screening/baseline visit.

          -  Subject has used intralesional kenalog within 4 weeks of screening/baseline visit.

          -  Subject has taken oral treatments for psoriasis within 4 weeks of screening/baseline
             visit.

          -  Subject has received any treatment with biologic medications within 5 half-lives (if
             known) or 16 weeks prior to screening/baseline, whichever is longer.

          -  Subject refuses to use adequate birth control during the duration of the study period.

          -  Subject is currently pregnant or breastfeeding.