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

Phase 3

Completed

• Conditions: Psoriasis
• Interventions: Drug: Vehicle Lotion; Drug: Vehicle Spray; Drug: DFD01 Spray; Drug: Comp01 Lotion

• Registration Number: NCT01947491
• Lead Sponsor: Primus Pharmaceuticals

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-09-17
• Study First Submitted QC: 2013-09-17
• Study First Posted: 2013-09-20
• Study Start: 2013-11
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Disposition First Submitted: 2016-02-08
• Disposition First Submitted QC: 2016-02-08
• Disposition First Posted: 2016-03-08
• Results First Submitted: 2016-08-15
• Results First Submitted QC: 2016-08-15
• Results First Posted: 2016-10-06
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-05
• Last Update Posted: 2024-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 394

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vehicle Lotion	Vehicle Lotion	Vehicle Lotion twice daily for 28 days
Vehicle Spray	Vehicle Spray	Vehicle Spray twice daily for 28 days
DFD01 Spray	DFD01 Spray	DFD01 Spray twice daily for 28 days
Comp01 Lotion	Comp01 Lotion	Comp01 Lotion twice daily for 14 days

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Success According to the Investigator Global Assessment (IGA)	Day 15	IGA of clear or almost clear

Trial Locations

Locations (40)

Rivergate Dermatology Clinical Research Center, PLLC; 🇺🇸 Goodlettsville, Tennessee, United States

The Center for Skin Research; 🇺🇸 Houston, Texas, United States

Skin Surgery Medical Group, Inc.; 🇺🇸 San Diego, California, United States

Stephen Miller, MD, PA; 🇺🇸 San Antonio, Texas, United States

Dermatology Research Center, Inc.; 🇺🇸 Salt Lake City, Utah, United States

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

Colorado Medical Research Center Inc.; 🇺🇸 Denver, Colorado, United States

Florida Academic Center Research and Education; 🇺🇸 Miami, Florida, United States

Redwood Dermatology Research; 🇺🇸 Santa Rosa, California, United States

International Dermatology Research Inc.; 🇺🇸 Miami, Florida, United States

Cherry Creek Research, Inc.; 🇺🇸 Denver, Colorado, United States

Compliant Clinical Research Inc.; 🇺🇸 Olathe, Kansas, United States

Wake Research Associates, LLC; 🇺🇸 Raleigh, North Carolina, United States

The Savin Center, PC; 🇺🇸 New Haven, Connecticut, United States

The Indiana Clinical Trials Center; 🇺🇸 Plainfield, Indiana, United States

Dermatology Specialists Research; 🇺🇸 Louisville, Kentucky, United States

David Fivenson, MD, PLC; 🇺🇸 Ann Arbor, Michigan, United States

Fran Cook-Bolden, MD; 🇺🇸 New York, New York, United States

Zoe Diane Draelos, MD, PA; 🇺🇸 High Point, North Carolina, United States

DermResearch, Inc.; 🇺🇸 Austin, Texas, United States

J & S Studies, Inc.; 🇺🇸 College Station, Texas, United States

Tennessee Clinical Research Center; 🇺🇸 Nashville, Tennessee, United States

PMG Research of Winston-Salem; 🇺🇸 Winston-Salem, North Carolina, United States

South Bend Clinic, LLP; 🇺🇸 South Bend, Indiana, United States

Center for Dematology Clinical Research, Inc.; 🇺🇸 Fremont, California, United States

Lawrence J. Green, MD, LLC; 🇺🇸 Rockville, Maryland, United States

Quality Clinical Research, Inc.; 🇺🇸 Omaha, Nebraska, United States

Academic Dermatology Associates; 🇺🇸 Albuquerque, New Mexico, United States

DermResearch Center of New York Stony Brook Medical Park; 🇺🇸 Stony Brook, New York, United States

Haber Dermatology & Cosmetic Surgery, Inc.; 🇺🇸 South Euclid, Ohio, United States

Center for Clinical Studies; 🇺🇸 Webster, Texas, United States

The Education & Research Foundation, Inc.; 🇺🇸 Lynchburg, Virginia, United States

Premier Clinical Research; 🇺🇸 Spokane, Washington, United States

Virginia Clinical Research, Inc.; 🇺🇸 Norfolk, Virginia, United States

Psoriasis Treatment Center of Central NJ; 🇺🇸 East Windsor, New Jersey, United States

Carolina Dermatology of Greenville, PA; 🇺🇸 Greenville, South Carolina, United States

Coastal Carolina Research Center; 🇺🇸 Mount Pleasant, South Carolina, United States