A Comparison of DFD01 Spray Versus Vehicle Spray in Subjects With Moderate Psoriasis

NCT ID: NCT01967069

Last Updated: 2024-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 277 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2014-07-31

Brief Summary

The objectives of this study are to compare the efficacy and safety of DFD01 Spray to Vehicle Spray for topical treatment of moderate plaque psoriasis

Conditions

Psoriasis

Study Design

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

Study Groups

DFD01 Spray

DFD01 Spray twice daily

Group Type: ACTIVE_COMPARATOR

DFD01 Spray

Intervention Type: DRUG

Vehicle Spray

Vehicle Spray twice daily

Group Type: PLACEBO_COMPARATOR

Vehicle Spray

Intervention Type: DRUG

Interventions

DFD01 Spray

Intervention Type: DRUG

Vehicle Spray

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Subjects must present with a clinical diagnosis of stable (at least 3 months) plaque-type psoriasis.

Subjects with psoriasis involving 10 to 20% BSA, not including the face, scalp, groin, axillae and other intertriginous areas.

Subjects must have an IGA grade of 3 (moderate) at the Baseline Visit

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 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, 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 within 1 year of the Baseline Visit.

Use within 60 days prior to the Baseline Visit of: 1) 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.

Require use of beta blockers, lithium, ACE inhibitors, and/or NSAIDs (indomethacin, ibuprofen, aspirin, naproxen) with a medical history that these medications affect the subject's psoriasis, except if the subject has been using the medication routinely during the 180 days prior to the Baseline Visit, these medications are allowed.

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

Sponsors

Prosoft Clinical

OTHER

Sponsor Role: collaborator

Primus Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Coastal Clinical Research, Inc.

Mobile, Alabama, United States

Hudson Dermatology/Clinical Research Advantage

Tempe, Arizona, United States

Dermatology Specialists, Inc.

Oceanside, California, United States

University Clinical Trials, Inc

San Diego, California, United States

Clinical Science Institute

Santa Monica, California, United States

Horizons Clinical Research Center, LLC

Denver, Colorado, United States

Skin Care Research, Inc.

Boca Raton, Florida, United States

MOORE Clinical Research, Inc.

Brandon, Florida, United States

FXM Research Corop.

Miami, Florida, United States

Dr. Tory P. Sullivan, MD, PA

North Miami Beach, Florida, United States

Augusta Centre for Dermatology and Skin Renewal, LLC

Augusta, Georgia, United States

Gwinnett Clinical Research Center, Inc.

Snellville, Georgia, United States

MLFKnuckles, MD, PSC

Corbin, Kentucky, United States

Shondra L. Smith, MD Dermatology & Advanced Aesthetics

Lake Charles, Louisiana, United States

Henry Ford Medical Center, New Center One

Detroit, Michigan, United States

Hamzavi Dermatology

Fort Gratiot, Michigan, United States

Grekin Skin Institute

Warren, Michigan, United States

Skin Specialists P.C.

Omaha, Nebraska, United States

Bettencourt Skin Center

Henderson, Nevada, United States

Skin Search of Rochester, Inc.

Rochester, New York, United States

Radiant Research, Inc.

Cincinnati, Ohio, United States

Brodell Medical, Inc.

Warren, Ohio, United States

Paddington Testing Company, Inc.

Philadelphia, Pennsylvania, United States

Center for Clinical Studies, LTD, LLP

Houston, Texas, United States

Dermatology Clinical Research Center of San Antonio

San Antonio, Texas, United States

Progressive Clinical Reesearch, PA

San Antonio, Texas, United States

Charlottesville Medical Research Center, LLC

Charlottesville, Virginia, United States

Eastern Washington Dermatology

Walla Walla, Washington, United States

Countries

United States

Other Identifiers

1206

Identifier Type: -

Identifier Source: org_study_id