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

Phase 3

Completed

Conditions: Chronic Stable Plaque Psoriasis

Interventions: Drug: DFD06-Cream
Drug: Vehicle Cream

Registration Number: NCT02445807

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: 265

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
Efficacy (Percentage of Subjects With Treatment Success)	Day 15 Visit	The primary efficacy endpoint is 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. The primary analysis was done with multiple imputations. Results are combined analyses from 5 imputed data sets.

Secondary Outcome Measures

Name	Time	Method
The Percentage of Subjects With Treatment Success at the Day 8 Visit.	At Day 8 Visit	The percentage of subjects with treatment success (defined as IGA = 0 or 1 and at least a 2 grade reduction from Baseline) at Day 8. The analysis was done with multiple imputations. Results are combined analyses from 5 imputed data sets.
The Percent Change in Body Surface Area of Psoriasis	From Baseline to Day 15	The percent change from baseline in Body Surface Area at Day 15. The analysis was done with multiple imputations. Results are combined analyses from 5 imputed data sets.

Trial Locations

Locations (30): Site 111
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Warren, Michigan, United States
Site 123
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Saint Joseph, Missouri, United States
Site 119
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Anderson, South Carolina, United States
Site 107
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Plano, Texas, United States
Site 126
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Spokane, Washington, United States
Site 102
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Greenville, South Carolina, United States
Site 115
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Miami, Florida, United States
Site 118
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Indianapolis, Indiana, United States
Site 122
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Houston, Texas, United States
Site 110
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Louisville, Kentucky, United States
Site 109
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Winston-Salem, North Carolina, United States
Site 108
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Austin, Texas, United States
Site 116
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Phoenix, Arizona, United States
Site 101
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Birmingham, Alabama, United States
Site 112
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Draper, Utah, United States
Site 121
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Walla Walla, Washington, United States
Site 130
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Mesa, Arizona, United States
Site 120
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North Hollywood, California, United States
Site 114
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San Diego, California, United States
Site 127
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Santa Monica, California, United States
Site 128
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Clearwater, Florida, United States
Site 105
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Glenn Dale, Maryland, United States
Site 113
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Fridley, Minnesota, United States
Site 104
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Albuquerque, New Mexico, United States
Site 124
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High Point, North Carolina, United States
Site 106
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Newington, New Hampshire, United States
Site 117
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Stony Brook, New York, United States
Site 129
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Johnston, Rhode Island, United States
Site 125
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Tucson, Arizona, United States
Site 103
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Mobile, Alabama, United States