A Comparison of DFD01 Spray Versus Comp01 Lotion, Vehicle Spray and Vehicle Lotion in Subjects With Moderate Psoriasis
1 other identifier
interventional
394
1 country
40
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2013
Shorter than P25 for phase_3
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 17, 2013
CompletedFirst Posted
Study publicly available on registry
September 20, 2013
CompletedStudy Start
First participant enrolled
November 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedResults Posted
Study results publicly available
October 6, 2016
CompletedMarch 7, 2024
March 1, 2024
1.2 years
September 17, 2013
August 15, 2016
March 5, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Success According to the Investigator Global Assessment (IGA)
IGA of clear or almost clear
Day 15
Study Arms (4)
DFD01 Spray
EXPERIMENTALDFD01 Spray twice daily for 28 days
Vehicle Spray
PLACEBO COMPARATORVehicle Spray twice daily for 28 days
Comp01 Lotion
ACTIVE COMPARATORComp01 Lotion twice daily for 14 days
Vehicle Lotion
PLACEBO COMPARATORVehicle Lotion twice daily for 28 days
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Primus Pharmaceuticalslead
- Prosoft Clinicalcollaborator
Study Sites (40)
Horizon Research Group, Inc.
Mobile, Alabama, 36608, United States
Burke Pharmaceutical Research
Hot Springs, Arkansas, 71913, United States
California Dermatology and Clinical Research Institute
Encinitas, California, 92024, United States
Encino Research Center
Encino, California, 91436, United States
Center for Dematology Clinical Research, Inc.
Fremont, California, 94538, United States
Skin Surgery Medical Group, Inc.
San Diego, California, 92117, United States
Redwood Dermatology Research
Santa Rosa, California, 95403, United States
Cherry Creek Research, Inc.
Denver, Colorado, 80209, United States
Colorado Medical Research Center Inc.
Denver, Colorado, 80210, United States
The Savin Center, PC
New Haven, Connecticut, 06511, United States
Florida Academic Center Research and Education
Miami, Florida, 33136, United States
International Dermatology Research Inc.
Miami, Florida, 33144, United States
The Indiana Clinical Trials Center
Plainfield, Indiana, 46168, United States
South Bend Clinic, LLP
South Bend, Indiana, 46617, United States
Compliant Clinical Research Inc.
Olathe, Kansas, 66061, United States
Dermatology Specialists Research
Louisville, Kentucky, 40202, United States
Lawrence J. Green, MD, LLC
Rockville, Maryland, 20850, United States
David Fivenson, MD, PLC
Ann Arbor, Michigan, 48103, United States
Quality Clinical Research, Inc.
Omaha, Nebraska, 68114, United States
Psoriasis Treatment Center of Central NJ
East Windsor, New Jersey, 08520, United States
Academic Dermatology Associates
Albuquerque, New Mexico, 87106, United States
Fran Cook-Bolden, MD
New York, New York, 10155, United States
DermResearch Center of New York Stony Brook Medical Park
Stony Brook, New York, 11790, United States
Zoe Diane Draelos, MD, PA
High Point, North Carolina, 27262, United States
Wake Research Associates, LLC
Raleigh, North Carolina, 27612, United States
PMG Research of Winston-Salem
Winston-Salem, North Carolina, 27101, United States
Haber Dermatology & Cosmetic Surgery, Inc.
South Euclid, Ohio, 44118, United States
Carolina Dermatology of Greenville, PA
Greenville, South Carolina, 29607, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464, United States
Rivergate Dermatology Clinical Research Center, PLLC
Goodlettsville, Tennessee, 37072, United States
Tennessee Clinical Research Center
Nashville, Tennessee, 37215, United States
DermResearch, Inc.
Austin, Texas, 78759, United States
J & S Studies, Inc.
College Station, Texas, 77845, United States
The Center for Skin Research
Houston, Texas, 77056, United States
Stephen Miller, MD, PA
San Antonio, Texas, 78249, United States
Center for Clinical Studies
Webster, Texas, 77598, United States
Dermatology Research Center, Inc.
Salt Lake City, Utah, 84117, United States
The Education & Research Foundation, Inc.
Lynchburg, Virginia, 24501, United States
Virginia Clinical Research, Inc.
Norfolk, Virginia, 23507, United States
Premier Clinical Research
Spokane, Washington, 99204, United States
Related Publications (1)
Sidgiddi S, Pakunlu RI, Allenby K. Efficacy, Safety, and Potency of Betamethasone Dipropionate Spray 0.05%: A Treatment for Adults with Mild-to-moderate Plaque Psoriasis. J Clin Aesthet Dermatol. 2018 Apr;11(4):14-22. Epub 2018 Apr 1.
PMID: 29657667DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director of Clinical Operations
- Organization
- Promius Pharma, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 17, 2013
First Posted
September 20, 2013
Study Start
November 1, 2013
Primary Completion
January 1, 2015
Study Completion
January 1, 2015
Last Updated
March 7, 2024
Results First Posted
October 6, 2016
Record last verified: 2024-03