Psoriasis Clinical Trial

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

Summary

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

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Full Description

To evaluate the potential of DFD-01 (betamethasone dipropionate) Spray, 0.05% to suppress the hypothalamic-pituitary-adrenal (HPA) axis when applied twice daily for 15 days or when applied twice daily for 29 days, in adolescent subjects with moderate to severe plaque psoriasis under maximal use conditions.

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Eligibility Criteria

Inclusion Criteria:

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.

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.
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.

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

3

Study ID:

NCT02527421

Recruitment Status:

Terminated

Sponsor:

Primus Pharmaceuticals

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There are 8 Locations for this study

See Locations Near You

Site 102
Encino California, 91436, United States
Site 104
Irvine California, 92697, United States
Site 100
San Diego California, 92123, United States
Site 109
Lebanon New Hampshire, 03756, United States
Site 107
New York New York, 10155, United States
Site 106
Arlington Texas, 76014, United States
Site 101
Houston Texas, 77030, United States
Site 105
San Antonio Texas, 78218, United States

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

3

Study ID:

NCT02527421

Recruitment Status:

Terminated

Sponsor:


Primus Pharmaceuticals

How clear is this clinincal trial information?

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