A Study of the Efficacy and Safety of DFD-06 Cream in the Treatment of Moderate to Severe Plaque Psoriasis

Phase 3

Completed

Conditions: Psoriasis

Interventions: Drug: DFD06 Cream
Drug: Vehicle Cream

Registration Number: NCT02635204

Lead Sponsor: Promius Pharma, LLC

Brief Summary: This study will compare the efficacy and safety of DFD-06 Cream to Vehicle Cream for topical treatment of moderate to severe plaque psoriasis after 3, 7, and 14 days of treatment.

Detailed Description: This study will be a multicenter (approximately 30 sites), randomized, vehicle-controlled, double-blind, and parallel group design. Approximately 264 subjects with moderate to severe plaque psoriasis will be randomized to treatment with DFD-06 Cream or Vehicle Cream. Subjects will use study product twice daily for 14 days. Subject visits are scheduled at Screening, Baseline (Day 1) and Days 4, 8, and 15. Clinical determinations of disease severity will be performed using the total sign score (TSS) for the target lesion and Investigator Global Assessment (IGA) for overall severity.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 267

Inclusion Criteria

Subject understands the study procedures and agrees to participate by giving written informed consent. Subjects must be willing to authorize use and disclosure of protected health information collected for the study.
Subject must be at least 18 years of age.
Subject must present with a clinical diagnosis of stable (at least 3 months) plaque-type psoriasis.
Subject with psoriasis involving 3% or greater BSA, not including the face, scalp, groin, axillae and other intertriginous areas.
Subject must have an IGA grade of 3 or 4 (moderate to severe) at the Baseline Visit.
Female subjects of childbearing potential must agree to use contraception during the study which can include abstinence with an adequate secondary option should the subject become sexually active. All women of childbearing potential must complete a urine pregnancy test (test must have a sensitivity of at least 25mIU/ml for human chorionic gonadotropin) at the Baseline Visit (Visit 2) and the test result must be negative to be eligible for enrollment.
Subject must be in good general health as determined by the investigator and supported by the medical history and normal or not clinically significant abnormal vital signs (blood pressure and pulse).

Exclusion Criteria

Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative or pustular psoriasis.
Other inflammatory skin disease that may confound the evaluation of the plaque psoriasis (e.g., atopic dermatitis, contact dermatitis, tinea corporis).
Presence of pigmentation, extensive scarring, or pigmented lesions or sunburn which could interfere with the rating of efficacy parameters.
History of psoriasis unresponsive to biological or topical treatments.
History of organ transplant requiring immunosuppression, HIV, or other immunocompromised state.
Use within 180 days prior to Baseline Visit of biologic treatment for psoriasis (e.g., infliximab, adalimumab, etanercept, ustekinumab, secukinumab, or alefacept).
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) systemic or topical immunosuppressive drugs (e.g., tacrolimus, pimecrolimus), 2) systemic antipsoriatic treatment (e.g., methotrexate, cyclosporine, hydroxyurea) or 3) oral retinoids (e.g., acitretin, isotretinoin).
Use within 30 days prior to the Baseline Visit of: 1) systemic steroids, 2) PUVA therapy, 3) systemic anti-inflammatory agents (e.g., mycophenolate mofetil, sulfasalazine, 6-thioguanine), or 4) UVB therapy. Inhaled, intraocular, and intranasal steroids are allowed.
Use within 14 days prior to the Baseline Visit of: 1) topical antipsoriatic drugs (e.g., salicylic acid, anthralin, coal tar, calcipotriene), 2) topical retinoids (e.g., tazarotene, tretinoin) or 3) topical corticosteroids.
Subjects who have participated in a study of an investigational drug 60 days prior to the Baseline Visit.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DFD-06 Cream	DFD06 Cream	DFD-06 Cream will be applied to subjects with moderate plaque psoriasis twice daily for 14 days.
Vehicle Cream	Vehicle Cream	Vehicle Cream will be applied to subjects with moderate plaque psoriasis twice daily for 14 days.

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects With Treatment Success at Day 15	Day 15 Visit	The percentage of subjects with treatment success (defined as IGA = 0 or 1 and at least a 2-grade reduction from baseline) at the Day 15 visit. Primary analysis was done with multiple imputations. Results are combined analyses from 5 imputed data sets.

Secondary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Body Surface Area at Day 15	Baseline and Day 15	Percent change from baseline in body surface area affected by psoriasis at Day 15. The analysis was done with multiple imputations. Results are combined analyses from 5 imputed data sets.
Percent of Subjects With Treatment Success at Day 8 Visit	Baseline and Day 8	Percent of subjects with treatment success at Day 8 Visit defined as an IGA of 0 or 1 with at least a 2 grade reduction from baseline. The analysis was done with multiple imputations. Results are combined analyses from 5 imputed data sets.

Trial Locations

Locations (30): 130
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West Palm Beach, Florida, United States
Site 115
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Overland Park, Kansas, United States
Site 122
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San Diego, California, United States
Site 123
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San Diego, California, United States
Site 109
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San Antonio, Texas, United States
Site 107
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Nashville, Tennessee, United States
Site 111
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Rogers, Arkansas, United States
Site 124
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Fountain Valley, California, United States
Site 116
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Glendale, Arizona, United States
Site 120
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Laguna Hills, California, United States
Site 113
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Denver, Colorado, United States
Site 108
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Brandon, Florida, United States
Site 112
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Coral Gables, Florida, United States
Site 106
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Jacksonville, Florida, United States
Site 110
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Pinellas Park, Florida, United States
Site 103
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Arlington Heights, Illinois, United States
Site 119
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Quincy, Massachusetts, United States
Site 114
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New York, New York, United States
Site 104
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Rocky Mount, North Carolina, United States
129
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Henderson, Nevada, United States
Site 126
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Cincinnati, Ohio, United States
Site 121
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Warwick, Rhode Island, United States
Site 101
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Dallas, Texas, United States
Site 102
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Houston, Texas, United States
Site 125
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Richmond, Virginia, United States
128
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Arlington, Texas, United States
Site 117
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New Haven, Connecticut, United States
Site 127
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Beverly, Massachusetts, United States
Site 118
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Norfolk, Virginia, United States
Site 105
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Wilmington, North Carolina, United States