Safety and Efficacy Study of Combination Treatment With Excimer Laser, Clobex Spray, and Vectical Ointment in the Treatment of Psoriasis
Condition: Chronic Stable Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Clobex Spray; Vectical Ointment; Excimer Laser
Intervention description: Clobex Spray BID for Weeks 1-4 and weeks 9-12; Vectical ointment BID for weeks 5-8 and 9-12; Laser treatment for weeks 1-6 study and as needed for patients with less than PASI-75 response thereafter.
Intervention MeSH terms: Calcitriol; Clobetasol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Psoriasis; Excimer; Laser; Clobex; Vectical; clobetasol spray; calcitriol; Generalized plaque type psoriasis

Summary:

      This is a 12-week, open-label, pilot trial evaluating the efficacy and safety of the
      combination of Clobex® spray with excimer laser therapy as the initial treatment of
      generalized plaque psoriasis, followed by maintenance therapy with topical Vectical. The
      study will be conducted in three distinct periods, namely Period A, Period B, and Period C,
      each of 4 weeks duration. During Period A (weeks 1 through 4), patients will use Clobex®
      spray twice daily along with excimer laser treatments twice weekly with the Photomedex XTRAC®
      Velocity machine. The goal of Period A is to achieve Psoriasis Area Severity Index (PASI) 75
      in 100% of patients within four weeks. During Period B (weeks 5 through 8), patients would be
      treated with topical Vectical® twice daily. Thus, there is a steroid-free interval during
      which patients will not be using Clobex® spray. The goal of Period B is to maintain the
      patient's response using only non-steroid options. During Period C of the study, patients
      will use Clobex® spray BID and Vectical® BID. Period C (weeks 9 through 12) will be a
      "booster" period in which the goal is to see if 100% of patients can achieve Psoriasis Area
      Severity Index (PASI) 90-100. Regarding excimer laser therapy: all patients will be receiving
      excimer laser therapy twice weekly for the first 6 weeks of the study (up to the halfway
      point) which is 12 excimer laser treatments. At that point, only those patients achieving
      <Psoriasis Area Severity Index (PASI)75 response will continue to receive twice weekly
      excimer laser treatments for the remaining 6 weeks of the study.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female subjects 18 years of age of older

          2. Subjects should have ≥ 10%, but not more than 20% total body involvement of stable
             plaque type psoriasis.

          3. Subjects must have BMI < 30 and weigh less than 250lbs

          4. Subjects must have Fitzpatrick Skin Type II or above (see Attachment A)

          5. Subjects must be able to discontinue any topical therapy (other than emollients) or
             received UVB phototherapy 2 weeks prior to starting the study.

          6. Subjects must be able to discontinue any biologic or systemic agents or oral psoralen
             with ultraviolet A 4 weeks prior to starting the study.

          7. Subject is able to complete the study and to comply with study instructions.

          8. Subject is capable of understanding and willing to provide signed and dated written
             voluntary informed consent (and any local or national authorization requirements)
             before any protocol specific procedures are performed.

          9. Any additional diagnoses must, in the investigator's opinion, not preclude the subject
             from safely participating in this study or interfere with the evaluation of the
             subject's psoriasis

        Exclusion Criteria:

          1. Subject is younger than 18 years of age.

          2. Subject has less than 10% or greater than 20% body surface involvement of his/her
             psoriasis.

          3. History of known or suspected intolerance to any of the ingredients of the
             investigational study product.

          4. Subject has a photosensitivity disorder (such as lupus, etc.) or a history of
             clinically significant photosensitivity.

          5. Subjects possess other diagnoses that, in the investigator's opinion, preclude him/her
             from safely participating in this study or interfere with the evaluation of the
             subject's psoriasis.

          6. Subject is not willing to discontinue topical treatment (other than emollients) or UVB
             phototherapy for 2 weeks prior to starting the study

          7. Subject is not willing to discontinue biologic or systemic agents or oral psoralen
             with ultraviolet A for 4 weeks prior to starting the study.

          8. Subject has psoriatic involvement only on the hands, feet, or scalp.

          9. Subject has been diagnosed with unstable or non-plaque forms of psoriasis, including
             guttate, erythrodermic, exfoliative, or pustular psoriasis.

         10. Subject has a history of keobnerization phenomenon

         11. Subject has keloids or past history of keloid formation

         12. Subject has melanoma or past history of melanoma

         13. Subject has active (cutaneous) invasive non-melanoma skin cancer (NMSC)

         14. Subject is determined not be a candidate for phototherapy by the investigator

         15. Subject has used other investigational drugs within 4 weeks prior to the study

         16. Subject is known, or suspected of being unable to comply with the study protocol