Evaluation of Adrenal Suppression Potential and Pharmacokinetics of Halobetasol Lotion 0.05%
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Halobetasol Topical Lotion
Intervention description: Halobetasol Lotion 0.05%, applied twice daily in subjects aged 12 to 16 years 11 months with stable plaque psoriasis.
Intervention MeSH terms: Clobetasol; Halobetasol
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Intervention model description: Open label study to evaluate adrenal suppression potential and pharmacokinetics of halobetasol lotion 0.05%
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 12 Years
Maximum age: 16 Years
Healthy volunteers: No

Summary:

      The objective of this open-label multicentric study is to determine the adrenal suppression
      potential and the pharmacokinetic (PK) properties of halobetasol lotion (HBP) applied twice
      daily for up to two weeks in subjects aged 12 to 16 years 11 months with stable plaque
      psoriasis. Subject enrollment will continue until at least 20 subjects with both screening
      and end of study (EOS) serum cortisol data (pre- and pos-tcosyntropin stimulation) have
      completed the study without any significant protocol violations (evaluable subjects). This
      may require the enrollment of approximately 25 subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject is male or non-pregnant female and is 12 to 16 years 11 months of age.

          2. Subject has provided written informed assent and was accompanied by the parent or
             legal guardian at the time of assent/consent signing. The parent or legal guardian has
             provided informed consent for the subject. 3. Subject has a clinical diagnosis of
             stable plaque psoriasis involving a minimum of 10% body surface area (BSA) within the
             Treatment Area. The "Treatment Area" is defined as the entire body exclusive of the
             face, scalp, groin, axillae, and other intertriginous areas.

        4. Subject has an Investigator's Global Assessment (IGA) score of at least three (3 =
        moderate) at the Baseline Visit.

        5. Subject is willing and able to apply the test article as directed, comply with study
        instructions and commit to all follow-up visits for the duration of the study.

        6. Females must have a negative urine pregnancy test (UPT) at the Screening and Baseline
        Visits and agree to use an effective form of birth control for the duration of the study.

        Exclusion Criteria:

          1. Subject has spontaneously improving or rapidly deteriorating plaque psoriasis.

          2. Subject has guttate, pustular, erythrodermic or other non-plaque forms of psoriasis.

          3. Subject has a physical condition which, in the investigator's opinion, might impair
             evaluation of plaque psoriasis, adrenal axis function (e.g., Addison's Disease,
             Cushing's Syndrome) or which exposes the subject to an unacceptable risk by study
             participation.

          4. Subject has used any phototherapy (including laser), photochemotherapy or systemic
             psoriasis therapy including methotrexate, retinoids, cyclosporine or biologics within
             30 days prior to the initiation of treatment with the test article.

          5. Subject has used systemic corticosteroids (including oral or intramuscular) or
             topical, inhaled or intranasal corticosteroids within 30 or 14 days, respectively,
             prior to Part B of the Screening Visit and/or the subject has used systemic or topical
             corticosteroids between Part B of the Screening Visit and the initiation of treatment.

          6. Subject has had prolonged exposure to natural or artificial sources of ultraviolet
             radiation within 30 days prior to the initiation of treatment or is intending to have
             such exposure during the study that is thought by the investigator to likely modify
             the subject's disease.

          7. Subject has used topical psoriatic therapy including tar, anthralin, retinoids,
             vitamin D analogs (e.g., Dovonex®) within 14 days prior to the initiation of treatment
             with the test article.

          8. Subject has used emollients/moisturizers on areas to be treated within one day prior
             to the initiation of treatment with the test article.

          9. Subject is currently using lithium or Plaquenil (hydroxychloroquine).

         10. Subject is currently using a beta-blocking medication (e.g., propranolol) or
             angiotensin converting enzyme (ACE) inhibitors (e.g., lisinopril) at a dose that has
             not been stabilized, in the opinion of the investigator.

         11. Subject has a history of sensitivity to any of the ingredients in the test article.

         12. Subject is pregnant, lactating, or is planning to become pregnant during the study.

         13. Subject is currently enrolled in an investigational drug or device study.

         14. Subject has used an investigational drug or investigational device treatment within 30
             days prior to Visit 1 (Screening).

         15. Subject has been previously enrolled in this study and treated with the test article.

         16. Subject has an irregular sleep schedule or works night shifts (cortisol levels exhibit
             physiological diurnal variation).

         17. Subject has a screening Cosyntropin Stimulation Test (CST) with a post 30-minute
             stimulation cortisol level of less than equal to 18 μg/dL.

         18. Subject is known to be noncompliant or is unlikely to comply with the requirements of
             the study protocol (e.g., due to alcoholism, drug dependency, mental incapacity) in
             the opinion