Clinical trial NCT02445807: A Study of the Efficacy and Safety of DFD-06 Cream in the Treatment of Moderate to Severe Plaque Psoriasis
Official title: A Randomized, Double-Blind, Vehicle-Controlled, Multicenter, Parallel Group Study of the Efficacy and Safety of DFD-06 Cream in the Treatment of Moderate to Severe Plaque Psoriasis for 14 Days
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Stable Plaque Psoriasis
Lead sponsor: Promius Pharma, LLC
Sponsor class: INDUSTRY
First posted: 2015-05-15
Enrollment: 265
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. Subject must be at least 18 years of age.
3. Subject must present with a clinical diagnosis of stable (at least 3 months) plaque-type psoriasis.
4. Subject with psoriasis involving 3% or greater BSA, not including the face, scalp, groin, axillae and other intertriginous areas.
5. Subject must have an IGA grade of 3 or 4 (moderate to severe) at the Baseline Visit.
6. 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.
7. 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:

1. Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative or pustular psoriasis.
2. Other inflammatory skin disease that may confound the evaluation of the plaque psoriasis (e.g., atopic dermatitis, contact dermatitis, tinea corporis).
3. Presence of pigmentation, extensive scarring, or pigmented lesions or sunburn which could interfere with the rating of efficacy parameters.
4. History of psoriasis unresponsive to biological or topical treatments.
5. History of organ transplant requiring immunosuppression, HIV, or other immunocompromised state.
6. Use within 180 days prior to Baseline Visit of biologic treatment for psoriasis (e.g., infliximab, adalimumab, etanercept, ustekinumab, secukinumab, or alefacept).
7. 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.
8. 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).
9. 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.
10. 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.
11. Subjects who have participated in a study of an investigational drug 60 days prior to the Baseline Visit.

Primary outcomes:
measure: Efficacy (Percentage of Subjects With Treatment Success)
timeFrame: Day 15 Visit
Secondary outcomes:
measure: The Percent Change in Body Surface Area of Psoriasis
timeFrame: From Baseline to Day 15
measure: The Percentage of Subjects With Treatment Success at the Day 8 Visit.
timeFrame: At Day 8 Visit
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Site 101
state: Alabama
city: Mobile
country: United States
facility: Site 103
state: Alabama
city: Mesa
country: United States
facility: Site 130
state: Arizona
city: Phoenix
country: United States
facility: Site 116
state: Arizona
city: Tucson
country: United States
facility: Site 125
state: Arizona
city: North Hollywood
country: United States
facility: Site 120
state: California
city: San Diego
country: United States
facility: Site 114
state: California
city: Santa Monica
country: United States
facility: Site 127
state: California
city: Clearwater
country: United States
facility: Site 128
state: Florida
city: Miami
country: United States
facility: Site 115
state: Florida
city: Indianapolis
country: United States
facility: Site 118
state: Indiana
city: Louisville
country: United States
facility: Site 110
state: Kentucky
city: Glenn Dale
country: United States
facility: Site 105
state: Maryland
city: Warren
country: United States
facility: Site 111
state: Michigan
city: Fridley
country: United States
facility: Site 113
state: Minnesota
city: Saint Joseph
country: United States
facility: Site 123
state: Missouri
city: Newington
country: United States
facility: Site 106
state: New Hampshire
city: Albuquerque
country: United States
facility: Site 104
state: New Mexico
city: Stony Brook
country: United States
facility: Site 117
state: New York
city: High Point
country: United States
facility: Site 124
state: North Carolina
city: Winston-Salem
country: United States
facility: Site 109
state: North Carolina
city: Johnston
country: United States
facility: Site 129
state: Rhode Island
city: Anderson
country: United States
facility: Site 119
state: South Carolina
city: Greenville
country: United States
facility: Site 102
state: South Carolina
city: Austin
country: United States
facility: Site 108
state: Texas
city: Houston
country: United States
facility: Site 122
state: Texas
city: Plano
country: United States
facility: Site 107
state: Texas
city: Draper
country: United States
facility: Site 112
state: Utah
city: Spokane
country: United States
facility: Site 126
state: Washington
city: Walla Walla
country: United States
facility: Site 121
state: Washington
Study officials:
affiliation: Dr Reddy's Laboratories Inc
name: Srinivas Sidgiddi, MD
role: STUDY_DIRECTOR
References: