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NCT01947491 Clinical Trial

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

Psoriasis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01947491
Other study ID # 1205
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date November 2013
Est. completion date January 2015

Study information
Verified date March 2024
Source Primus Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 394
Est. completion date January 2015
Est. primary completion date January 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• DFD01 Spray

• Comp01 Lotion

• Vehicle Lotion

• Vehicle Spray

Locations
Country Name City State
United States Academic Dermatology Associates Albuquerque New Mexico
United States David Fivenson, MD, PLC Ann Arbor Michigan
United States DermResearch, Inc. Austin Texas
United States J & S Studies, Inc. College Station Texas
United States Cherry Creek Research, Inc. Denver Colorado
United States Colorado Medical Research Center Inc. Denver Colorado
United States Psoriasis Treatment Center of Central NJ East Windsor New Jersey
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 Rivergate Dermatology Clinical Research Center, PLLC Goodlettsville Tennessee
United States Carolina Dermatology of Greenville, PA Greenville South Carolina
United States Zoe Diane Draelos, MD, PA High Point North Carolina
United States Burke Pharmaceutical Research Hot Springs Arkansas
United States The Center for Skin Research Houston Texas
United States Dermatology Specialists Research Louisville Kentucky
United States The Education & Research Foundation, Inc. Lynchburg Virginia
United States Florida Academic Center Research and Education Miami Florida
United States International Dermatology Research Inc. Miami Florida
United States Horizon Research Group, Inc. Mobile Alabama
United States Coastal Carolina Research Center Mount Pleasant South Carolina
United States Tennessee Clinical Research Center Nashville Tennessee
United States The Savin Center, PC New Haven Connecticut
United States Fran Cook-Bolden, MD New York New York
United States Virginia Clinical Research, Inc. Norfolk Virginia
United States Compliant Clinical Research Inc. Olathe Kansas
United States Quality Clinical Research, Inc. Omaha Nebraska
United States The Indiana Clinical Trials Center Plainfield Indiana
United States Wake Research Associates, LLC Raleigh North Carolina
United States Lawrence J. Green, MD, LLC Rockville Maryland
United States Dermatology Research Center, Inc. Salt Lake City Utah
United States Stephen Miller, MD, PA San Antonio Texas
United States Skin Surgery Medical Group, Inc. San Diego California
United States Redwood Dermatology Research Santa Rosa California
United States South Bend Clinic, LLP South Bend Indiana
United States Haber Dermatology & Cosmetic Surgery, Inc. South Euclid Ohio
United States Premier Clinical Research Spokane Washington
United States DermResearch Center of New York Stony Brook Medical Park Stony Brook New York
United States Center for Clinical Studies Webster Texas
United States PMG Research of Winston-Salem Winston-Salem North Carolina

Sponsors (2)
Lead Sponsor Collaborator
Primus Pharmaceuticals Prosoft Clinical

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of Participants With Success According to the Investigator Global Assessment (IGA) IGA of clear or almost clear Day 15
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