Clinical trial NCT02635204: 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: Psoriasis
Lead sponsor: Promius Pharma, LLC
Sponsor class: INDUSTRY
First posted: 2015-12-18
Enrollment: 267
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: Percentage of Subjects With Treatment Success at Day 15
timeFrame: Day 15 Visit
Secondary outcomes:
measure: Percent Change From Baseline in Body Surface Area at Day 15
timeFrame: Baseline and Day 15
measure: Percent of Subjects With Treatment Success at Day 8 Visit
timeFrame: Baseline and Day 8
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Site 116
state: Arizona
city: Rogers
country: United States
facility: Site 111
state: Arkansas
city: Fountain Valley
country: United States
facility: Site 124
state: California
city: Laguna Hills
country: United States
facility: Site 120
state: California
city: San Diego
country: United States
facility: Site 122
state: California
city: San Diego
country: United States
facility: Site 123
state: California
city: Denver
country: United States
facility: Site 113
state: Colorado
city: New Haven
country: United States
facility: Site 117
state: Connecticut
city: Brandon
country: United States
facility: Site 108
state: Florida
city: Coral Gables
country: United States
facility: Site 112
state: Florida
city: Jacksonville
country: United States
facility: Site 106
state: Florida
city: Pinellas Park
country: United States
facility: Site 110
state: Florida
city: West Palm Beach
country: United States
facility: 130
state: Florida
city: Arlington Heights
country: United States
facility: Site 103
state: Illinois
city: Overland Park
country: United States
facility: Site 115
state: Kansas
city: Beverly
country: United States
facility: Site 127
state: Massachusetts
city: Quincy
country: United States
facility: Site 119
state: Massachusetts
city: Henderson
country: United States
facility: 129
state: Nevada
city: New York
country: United States
facility: Site 114
state: New York
city: Rocky Mount
country: United States
facility: Site 104
state: North Carolina
city: Wilmington
country: United States
facility: Site 105
state: North Carolina
city: Cincinnati
country: United States
facility: Site 126
state: Ohio
city: Warwick
country: United States
facility: Site 121
state: Rhode Island
city: Nashville
country: United States
facility: Site 107
state: Tennessee
city: Arlington
country: United States
facility: 128
state: Texas
city: Dallas
country: United States
facility: Site 101
state: Texas
city: Houston
country: United States
facility: Site 102
state: Texas
city: San Antonio
country: United States
facility: Site 109
state: Texas
city: Norfolk
country: United States
facility: Site 118
state: Virginia
city: Richmond
country: United States
facility: Site 125
state: Virginia
Study officials:
affiliation: Dr. Reddy's Laboratories, Inc
name: Srinivas Sidgiddi, MD
role: STUDY_DIRECTOR
References: