DFD06 Cream vs Clobetasol Propionate Cream, 0.05% Hypothalamic- Pituitary-Adrenal (HPA) Axis Suppression Study in Patients With Moderate to Severe Plaque Psoriasis

Completed · Phase 2

Conditions studied: Psoriasis

In brief

The purpose of this study is to evaluate the potential of DFD06 cream to suppress the HPA (hypothalamic-pituitary-adrenal) axis as compared to clobetasol propionate cream, 0.05% cream when applied twice daily for 15 days.

Key facts

Study ID

NCT02131324

Run by

Promius Pharma, LLC

People needed

50

Starts

2014-05-08

Expected to finish

2016-08-11

Last updated by the study team

2018-05-18

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must present with a clinical diagnosis of stable (at least 3 months) plaque psoriasis.
• Subjects with psoriasis involving 20 to 50% Body Surface Area (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 Adrenocorticotropic hormone (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

You may not qualify if…

• 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) psoralen and ultraviolet A (PUVA) therapy, 3) systemic anti-inflammatory agents (e.g., mycophenolate mofetil, sulfasalazine, 6-thioguanine), or 4) ultraviolet B (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.

Where it is running

• Advanced Research Associates — Glendale, Arizona, United States
• Agave Clinical Research, LLC — Mesa, Arizona, United States
• T. Joseph Raoof, MD, Inc. — Encino, California, United States
• International Dermatology Research, Inc. — Miami, Florida, United States
• FXM Research Corp. — Miami, Florida, United States
• FXM Research Miramar — Miramar, Florida, United States
• Belleair Research — Pinellas Park, Florida, United States
• Forward Clinical Trials — Tampa, Florida, United States
• Marietta Dermatology Clinical Research, Inc. — Marietta, Georgia, United States
• Determatology Specialists Research, LLC — Louisville, Kentucky, United States
• Quality Clinical Research, Inc. — Omaha, Nebraska, United States
• Dermatology Consulting Services — High Point, North Carolina, United States
• Lynn Health Science Institute — Oklahoma City, Oklahoma, United States
• Clinical Partners, LLC — Johnston, Rhode Island, United States
• Radiant Research, Inc. — Greer, South Carolina, United States

Full record on ClinicalTrials.gov

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