Psoriasis Clinical Trial

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

Summary

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.

View Eligibility Criteria

Eligibility Criteria

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.

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

75

Study ID:

NCT02070965

Recruitment Status:

Completed

Sponsor:

Primus Pharmaceuticals

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There are 12 Locations for this study

See Locations Near You

California Dermatology and Clinical Research Institute
Encinitas California, 92024, United States
Encino Research Center T. Joseph Raoof MD, Inc.
Encino California, 91436, United States
Redwood Dermatology Research
Santa Rosa California, 95403, United States
Bettencourt Skin Center
Henderson Nevada, 89074, United States
Academic Dermatology Associates
Albuquerque New Mexico, 87106, United States
Dermatology Consulting Services
High Point North Carolina, 27262, United States
Paddington Testing Company, Inc.
Philadelphia Pennsylvania, 19101, United States
Tennessee Clinical Research Center
Nashville Tennessee, 37215, United States
DermResearch, Inc.
Austin Texas, 78759, United States
Center for Clinical Studies, LTD. LLP
Houston Texas, 77004, United States
The University of Texas Health Science Center at Houston
Houston Texas, 77030, United States
Suzanne Bruce and Associates, PA The Center for Skin Research Katy/Cinco Ranch
Katy Texas, 77494, United States

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

75

Study ID:

NCT02070965

Recruitment Status:

Completed

Sponsor:


Primus Pharmaceuticals

How clear is this clinincal trial information?

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