A Comparison of DFD01 Spray Versus Comp01 Lotion, Vehicle Spray and Vehicle Lotion in Subjects With Moderate Psoriasis

Completed · Phase 3

Conditions studied: Psoriasis

In brief

The objectives of this study are to compare the safety of DFD01 Spray to Comp01 Lotion for topical treatment of moderate plaque psoriasis and to compare the efficacy of DFD01 Spray to Placebo Spray for topical treatment of moderate plaque psoriasis after 28 days of treatment.

Key facts

Study ID

NCT01947491

Run by

Primus Pharmaceuticals

People needed

394

Starts

2013-11-01

Expected to finish

2015-01-01

Last updated by the study team

2024-03-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Horizon Research Group, Inc. — Mobile, Alabama, United States
• Burke Pharmaceutical Research — Hot Springs, Arkansas, United States
• California Dermatology and Clinical Research Institute — Encinitas, California, United States
• Encino Research Center — Encino, California, United States
• Center for Dematology Clinical Research, Inc. — Fremont, California, United States
• Skin Surgery Medical Group, Inc. — San Diego, California, United States
• Redwood Dermatology Research — Santa Rosa, California, United States
• Cherry Creek Research, Inc. — Denver, Colorado, United States
• Colorado Medical Research Center Inc. — Denver, Colorado, United States
• The Savin Center, PC — New Haven, Connecticut, United States
• Florida Academic Center Research and Education — Miami, Florida, United States
• International Dermatology Research Inc. — Miami, Florida, United States
• The Indiana Clinical Trials Center — Plainfield, Indiana, United States
• South Bend Clinic, LLP — South Bend, Indiana, United States
• Compliant Clinical Research Inc. — Olathe, Kansas, United States
• Dermatology Specialists Research — Louisville, Kentucky, United States
• Lawrence J. Green, MD, LLC — Rockville, Maryland, United States
• David Fivenson, MD, PLC — Ann Arbor, Michigan, United States
• Quality Clinical Research, Inc. — Omaha, Nebraska, United States
• Psoriasis Treatment Center of Central NJ — East Windsor, New Jersey, United States
• Academic Dermatology Associates — Albuquerque, New Mexico, United States
• Fran Cook-Bolden, MD — New York, New York, United States
• DermResearch Center of New York Stony Brook Medical Park — Stony Brook, New York, United States
• Zoe Diane Draelos, MD, PA — High Point, North Carolina, United States
• Wake Research Associates, LLC — Raleigh, North Carolina, United States

Full record on ClinicalTrials.gov

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