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

NCT ID: NCT02445807

Last Updated: 2018-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 265 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2016-07-31

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.

Conditions

Chronic Stable Plaque Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

DFD-06 cream

DFD-06 Cream will be applied to subjects with moderate plaque psoriasis twice daily for 14 days.

Group Type: EXPERIMENTAL

DFD06-Cream

Intervention Type: DRUG

Twice daily topical application for 14 days.

Vehicle Cream

Vehicle Cream will be applied to subjects with moderate plaque psoriasis twice daily for 14 days.

Group Type: PLACEBO_COMPARATOR

Vehicle Cream

Intervention Type: DRUG

Twice daily topical application for 14 days.

Interventions

DFD06-Cream

Twice daily topical application for 14 days.

Intervention Type: DRUG

Vehicle Cream

Twice daily topical application for 14 days.

Intervention Type: DRUG

Other Intervention Names

Clobetasol propionate Cream, 0.025%

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Promius Pharma, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Srinivas Sidgiddi, MD

Role: STUDY_DIRECTOR

Dr Reddy's Laboratories Inc

Locations

Site 101

Birmingham, Alabama, United States

Site 103

Mobile, Alabama, United States

Site 130

Mesa, Arizona, United States

Site 116

Phoenix, Arizona, United States

Site 125

Tucson, Arizona, United States

Site 120

North Hollywood, California, United States

Site 114

San Diego, California, United States

Site 127

Santa Monica, California, United States

Site 128

Clearwater, Florida, United States

Site 115

Miami, Florida, United States

Site 118

Indianapolis, Indiana, United States

Site 110

Louisville, Kentucky, United States

Site 105

Glenn Dale, Maryland, United States

Site 111

Warren, Michigan, United States

Site 113

Fridley, Minnesota, United States

Site 123

Saint Joseph, Missouri, United States

Site 106

Newington, New Hampshire, United States

Site 104

Albuquerque, New Mexico, United States

Site 117

Stony Brook, New York, United States

Site 124

High Point, North Carolina, United States

Site 109

Winston-Salem, North Carolina, United States

Site 129

Johnston, Rhode Island, United States

Site 119

Anderson, South Carolina, United States

Site 102

Greenville, South Carolina, United States

Site 108

Austin, Texas, United States

Site 122

Houston, Texas, United States

Site 107

Plano, Texas, United States

Site 112

Draper, Utah, United States

Site 126

Spokane, Washington, United States

Site 121

Walla Walla, Washington, United States

Countries

United States

Other Identifiers

DFD06-CD-005

Identifier Type: -

Identifier Source: org_study_id