Assess the Potential for Adrenal Suppression and Systemic Drug Absorption Following Multiple Dosing With DFD-06

Study Overview
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Brief Summary
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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.

Detailed Description
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This is a 15-day, single arm, multicenter, multi-dose, open-label, two stage, sequential study. 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). An attempt will be made to enroll subjects throughout the age range of each cohort including the lower age range. DFD-06 will be applied twice daily to all affected areas on the body excluding face, scalp, groin, axillae and other intertriginous areas. Subjects must have ≥10% Body Surface Area (BSA) treated to achieve maximal use exposure.

Official Title
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An Open Label, Multicenter Study to Assess the Potential for Adrenal Suppression and Systemic Drug Absorption Following Multiple Dosing With DFD-06 in Pediatric Subjects With Moderate to Severe Plaque Psoriasis

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: DFD06


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Sequential Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DFD-06 Cream<br>This is a single arm, open label study and there will be no reference or control product used in this study | Drug: DFD06<br>* Apply twice per day for 15 days<br>* Other names: clobetasol propionate, Impoyz Cream;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects With HPA Axis Suppression at Day 15 | The percentage of subjects with abnormal cortisol response for ACTH stimulation test at Day 15 (cortisol level ≤18 µg/dL at 30 minutes post stimulation) is the primary variable | Day 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Improvement in IGA Grade From Baseline | Numbers of subjects with improvements by at least 1 pint in IGA grade will be provided as descriptive statistics. | Baseline up to Day 15 | 
| Plasma Concentration of Clobetasol Propionate | Plasma concentrations of clobetasol propionate after multiple doses of DFD-06 under maximal use condition with the final-to-be-marketed formulation. | Day 15 0 hour, 1 hour, 3 hours, 6 hours after application |