DFD01 Spray HPA Axis Suppression Study in Adolescent Patients With Moderate to Severe Plaque Psoriasis

Stopped early · Phase 3

Conditions studied: Plaque Psoriasis

In brief

To evaluate the potential of DFD-01 (betamethasone dipropionate) Spray, 0.05% to suppress the hypothalamic-pituitary-adrenal (HPA) axis.

Key facts

Study ID

NCT02527421

Run by

Primus Pharmaceuticals

People needed

3

Starts

2015-08-19

Expected to finish

2019-03-30

Last updated by the study team

2024-03-07

Who can join

Age: 12 and older, up to 16. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must weigh at least 55 pounds
• Subjects must present with a clinical diagnosis of stable (at least 3 months) plaque psoriasis.
• Subjects with psoriasis involving ≥ 10% BSA, not including the face, scalp, groin, axillae and other intertriginous areas..
• Subjects must have moderate to severe plaque psoriasis 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 axis 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.
• Use within 60 days prior to the Baseline Visit of: 1) immunosuppressive drugs (e.g., tacrolimus, pimecrolimus), 2) systemic antipsoriatic treatment (e.g., methotrexate, cyclosporine, hydroxyurea), or 3) biologic treatment for psoriasis (e.g., infliximab, adalimumab, etanercept, ustekinumab, secukinumab, or alefacept).
• 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 overnight.
• 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

• Site 102 — Encino, California, United States
• Site 104 — Irvine, California, United States
• Site 100 — San Diego, California, United States
• Site 109 — Lebanon, New Hampshire, United States
• Site 107 — New York, New York, United States
• Site 106 — Arlington, Texas, United States
• Site 101 — Houston, Texas, United States
• Site 105 — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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