DFD01 Spray vs Comp01 Lotion HPA Axis Suppression Study in Patients With Moderate to Severe Plaque Psoriasis

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the potential of DFD01 spray to suppress the HPA (hypothalamic-pituitary-adrenal) axis as compared to Comp01 lotion when applied twice daily for 15 days.

Official Title
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Randomized Parallel Group Open-Label Multicenter Study to Assess the Potential for Adrenal Supp and Syst Drug Abs Following Multi Dosing With DFD-01 (Betamethasone Dipropionate) Spray 0.05% in Adol Subjects With Mod to Sev Plaque Psoriasis

Conditions
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Plaque Psoriasis

Intervention / Treatment
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* Drug: DFD01 Spray
* Drug: Comp01 Lotion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must present with a clinical diagnosis of stable (at least 3 months) plaque psoriasis. Subjects with psoriasis involving 20 to 50% BSA, not including the face, scalp, groin, axillae and other intertriginous areas. Subjects must have an IGA grade of at least 3 (moderate) at the Baseline Visit Subjects whose results from the screening ACTH stimulation test are considered normal (cortisol level >18 ug/dL at 30 minutes post stimulation) and show no other signs of abnormal HPA function or adrenal response. - Exclusion Criteria: Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative or pustular psoriasis. History of organ transplant requiring immunosuppression, HIV, or other immunocompromised state. Have 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. Use within 60 days prior to the Baseline Visit of: 1) immunosuppressive drugs (e.g., tacrolimus, pimecrolimus), or 2) systemic antipsoriatic treatment (e.g., methotrexate, cyclosporine, hydroxyurea) Use within 30 days prior to the Baseline Visit of: 1) topical antipsoriatic drugs (salicylic acid, anthralin, coal tar, calcipotriene)2) PUVA therapy, 3) systemic anti-inflammatory agents (e.g., mycophenolate mofetil, sulfasalazine, 6-thioguanine), or 4) UVB therapy. Use within 30 days prior to the Screening Visit of any product containing corticosteroids. Inhaled, intraocular, intranasal, etc. steroids are not allowed. Subjects who have an abnormal sleep schedule or work at night. Subjects with a known history of acute adrenal crisis, Addison's disease or decreased adrenal output, low pituitary function or pituitary tumors. Subjects who have a history of an adverse reaction to cosyntropin injection or similar test reagents.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DFD01 Spray Group 1<br>DFD01 Spray, bid, 28 days | Drug: DFD01 Spray<br> <br> |
| Active Comparator: Comp01 Lotion<br>Comp01 Lotion, bid, 14 days | Drug: Comp01 Lotion<br> <br> |
| Experimental: DFD01 Spray Group 2<br>DFD01 Spray, bid, 14 days | Drug: DFD01 Spray<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Subjects With HPA Axis Suppression |  | Day 15 |