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

Completed · Phase 2

Conditions studied: Plaque Psoriasis

In brief

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.

Key facts

Study ID

NCT02070965

Run by

Primus Pharmaceuticals

People needed

75

Starts

2014-01-01

Expected to finish

2014-10-01

Last updated by the study team

2024-03-07

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% 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. -

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) 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.

Where it is running

• California Dermatology and Clinical Research Institute — Encinitas, California, United States
• Encino Research Center T. Joseph Raoof MD, Inc. — Encino, California, United States
• Redwood Dermatology Research — Santa Rosa, California, United States
• Bettencourt Skin Center — Henderson, Nevada, United States
• Academic Dermatology Associates — Albuquerque, New Mexico, United States
• Dermatology Consulting Services — High Point, North Carolina, United States
• Paddington Testing Company, Inc. — Philadelphia, Pennsylvania, United States
• Tennessee Clinical Research Center — Nashville, Tennessee, United States
• DermResearch, Inc. — Austin, Texas, United States
• Center for Clinical Studies, LTD. LLP — Houston, Texas, United States
• The University of Texas Health Science Center at Houston — Houston, Texas, United States
• Suzanne Bruce and Associates, PA The Center for Skin Research Katy/Cinco Ranch — Katy, Texas, United States

Full record on ClinicalTrials.gov

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