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| Name | Class |
|---|---|
| Prosoft Clinical | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DFD01 Spray | Experimental | DFD01 Spray twice daily for 28 days |
|
| Vehicle Spray | Placebo Comparator | Vehicle Spray twice daily for 28 days |
|
| Comp01 Lotion | Active Comparator | Comp01 Lotion twice daily for 14 days |
|
| Vehicle Lotion | Placebo Comparator | Vehicle Lotion twice daily for 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DFD01 Spray | Drug |
|
| |
| Comp01 Lotion |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Success According to the Investigator Global Assessment (IGA) | IGA of clear or almost clear | Day 15 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Horizon Research Group, Inc. | Mobile | Alabama | 36608 | United States | ||
| Burke Pharmaceutical Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29657667 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | DFD01 Spray | DFD01 Spray twice daily for 28 days DFD01 Spray |
| FG001 | Vehicle Spray | Vehicle Spray twice daily for 28 days Vehicle Spray |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
|
|
| Vehicle Lotion | Drug |
|
| Vehicle Spray | Drug |
|
| 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 |
| FG002 | Comp01 Lotion | Comp01 Lotion twice daily for 14 days Comp01 Lotion |
| FG003 | Vehicle Lotion | Vehicle Lotion twice daily for 28 days Vehicle Lotion |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | DFD01 Spray | DFD01 Spray twice daily for 28 days DFD01 Spray |
| BG001 | Vehicle Spray | Vehicle Spray twice daily for 28 days Vehicle Spray |
| BG002 | Comp01 Lotion | Comp01 Lotion twice daily for 14 days Comp01 Lotion |
| BG003 | Vehicle Lotion | Vehicle Lotion twice daily for 28 days Vehicle Lotion |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Success According to the Investigator Global Assessment (IGA) | IGA of clear or almost clear | Efficacy was only done on DFD01 Spray and Vehicle Spray. Protocol specifically noted no efficacy would be done on comparator or its vehicle. | Posted | Number | 95% Confidence Interval | percentage of patients | Day 15 |
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One subject in the betamethasone dipropionate 0.05% group had no post-baseline safety evaluations.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DFD01 Spray | DFD01 Spray twice daily for 28 days DFD01 Spray | 0 | 173 | 23 | 173 | ||
| EG001 | Vehicle Spray | Vehicle Spray twice daily for 28 days Vehicle Spray | 1 | 87 | 15 | 87 | ||
| EG002 | Comp01 Lotion | Comp01 Lotion twice daily for 14 days Comp01 Lotion | 2 | 90 | 19 | 90 | ||
| EG003 | Vehicle Lotion | Vehicle Lotion twice daily for 28 days Vehicle Lotion | 0 | 43 | 20 | 43 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diabetes Mellitus | Metabolism and nutrition disorders |
| |||
| Convulsion | Nervous system disorders |
| |||
| Alcohol Withdrawal Syndrome | Psychiatric disorders |
| |||
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders |
| |||
| Urinary Tract Infection | Infections and infestations |
| |||
| Fall | Injury, poisoning and procedural complications |
| |||
| Hyponatraemia | Metabolism and nutrition disorders |
| |||
| Metabolic Acidosis | Metabolism and nutrition disorders |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application Site Pain | General disorders |
| |||
| Application Site Pruritis | General disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Operations | Promius Pharma, LLC | 609-282-1476 | kgulbronson@promiuspharma.com |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Male |
|