Assess the Potential for Adrenal Suppression and Systemic Drug Absorption Following Multiple Dosing With DFD-06
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: DFD06
Intervention description: Apply twice per day for 15 days
Intervention MeSH terms: Clobetasol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Sequential Assignment
Intervention model description: In the first stage, subjects who are at least 12 years of age and not more than 16.9 years (16 years and 11 months) of age with moderate to severe plaque psoriasis will be treated with DFD-06 (at least 20 completed subjects). In the second stage subjects who are at least 6 years of age and not more than 11.9 years (11 years and 11 months) of age with moderate to severe plaque psoriasis will be treated with DFD-06 (at least 20 completed subjects).
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the potential of DFD-06 to suppress the
      hypothalamic-pituitary-adrenal (HPA) axis when applied twice daily for 15 days.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects and the parent or legal guardian understand the study procedures and agree to
             participate by giving assent and written informed consent, respectively. Subject's
             parent or legal guardian must be willing to authorize use and disclosure of protected
             health information collected for the study.

          -  Subjects must be at least 6 years and not more than 16.9 years of age, with body
             weight greater than or equal to 45 pounds at Screening.

          -  Subjects must present with a clinical diagnosis of stable (at least 3 months) plaque
             psoriasis.

          -  Subjects with psoriasis involving ≥10% Body Surface Area (BSA), not including the
             face, scalp, groin, axillae and other intertriginous areas at the Baseline Visit.

          -  Subjects must have an Investigator Global Assessment (IGA) grade of at least 3
             (moderate) at the Baseline Visit.

        Exclusion Criteria:

          -  Subject has a current diagnosis of unstable forms of psoriasis including guttate,
             erythrodermic, exfoliative or pustular psoriasis.

          -  Subject has a history of organ transplant requiring immunosuppression, HIV, or other
             immunocompromised state.

          -  Subject has received treatment for any type of cancer within 5 years of the Baseline
             Visit except skin cancer and cervical cancer (in situ) are allowed if at least 1 year
             before the Baseline Visit.

          -  Subject has a history or presence of intracranial hypertension.

          -  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