Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Prosoft Clinical | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objectives of this study are to compare the efficacy and safety of DFD01 Spray to Vehicle Spray for topical treatment of moderate plaque psoriasis
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DFD01 Spray | Active Comparator | DFD01 Spray twice daily |
|
| Vehicle Spray | Placebo Comparator | Vehicle Spray twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DFD01 Spray | Drug |
| ||
| Vehicle Spray |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Treatment Success According to the Investigator's Global Assessment (IGA) | IGA of clear or almost clear | Day 15 |
Not provided
Not provided
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.
Use within 180 days prior to Baseline Visit of biologic treatment for psoriasis (e.g., infliximab, adalimumab, etanercept, ustekinumab, or alefacept).
Have received treatment for any type of cancer within 5 years of the Baseline Visit except skin cancer and cervical cancer (in situ) are allowed within 1 year of the Baseline Visit.
Use within 60 days prior to the Baseline Visit of: 1) immunosuppressive drugs (e.g., tacrolimus, pimecrolimus), 2) systemic antipsoriatic treatment (e.g., methotrexate, cyclosporine, hydroxyurea) or 3) oral retinoids (e.g., acitretin, isotretinoin).
Use within 30 days prior to the Baseline Visit of: 1) systemic steroids, 2) PUVA therapy, 3) systemic anti-inflammatory agents (e.g., mycophenolate mofetil, sulfasalazine, 6-thioguanine), or 4) UVB therapy. Inhaled, intraocular, and intranasal steroids are allowed.
Use within 14 days prior to the Baseline Visit of: 1) topical antipsoriatic drugs (e.g., salicylic acid, anthralin, coal tar, calcipotriene), 2) topical retinoids (e.g., tazarotene, tretinoin) or 3) topical corticosteroids.
Require use of beta blockers, lithium, ACE inhibitors, and/or NSAIDs (indomethacin, ibuprofen, aspirin, naproxen) with a medical history that these medications affect the subject's psoriasis, except if the subject has been using the medication routinely during the 180 days prior to the Baseline Visit, these medications are allowed.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coastal Clinical Research, Inc. | Mobile | Alabama | 36608 | United States | ||
| Hudson Dermatology/Clinical Research Advantage |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | DFD01 Spray | DFD01 Spray twice daily DFD01 Spray |
| FG001 | Vehicle Spray | Vehicle Spray twice daily Vehicle Spray |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Tempe |
| Arizona |
| 85282 |
| United States |
| Dermatology Specialists, Inc. | Oceanside | California | 92056 | United States |
| University Clinical Trials, Inc | San Diego | California | 92123 | United States |
| Clinical Science Institute | Santa Monica | California | 90404 | United States |
| Horizons Clinical Research Center, LLC | Denver | Colorado | 80220 | United States |
| Skin Care Research, Inc. | Boca Raton | Florida | 33486 | United States |
| MOORE Clinical Research, Inc. | Brandon | Florida | 33511 | United States |
| FXM Research Corop. | Miami | Florida | 33175 | United States |
| Dr. Tory P. Sullivan, MD, PA | North Miami Beach | Florida | 33162 | United States |
| Augusta Centre for Dermatology and Skin Renewal, LLC | Augusta | Georgia | 30909 | United States |
| Gwinnett Clinical Research Center, Inc. | Snellville | Georgia | 30078 | United States |
| MLFKnuckles, MD, PSC | Corbin | Kentucky | 40701 | United States |
| Shondra L. Smith, MD Dermatology & Advanced Aesthetics | Lake Charles | Louisiana | 70605 | United States |
| Henry Ford Medical Center, New Center One | Detroit | Michigan | 48202 | United States |
| Hamzavi Dermatology | Fort Gratiot | Michigan | 48059 | United States |
| Grekin Skin Institute | Warren | Michigan | 48088 | United States |
| Skin Specialists P.C. | Omaha | Nebraska | 68144 | United States |
| Bettencourt Skin Center | Henderson | Nevada | 89074 | United States |
| Skin Search of Rochester, Inc. | Rochester | New York | 14623 | United States |
| Radiant Research, Inc. | Cincinnati | Ohio | 45249 | United States |
| Brodell Medical, Inc. | Warren | Ohio | 44483 | United States |
| Paddington Testing Company, Inc. | Philadelphia | Pennsylvania | 19103 | United States |
| Center for Clinical Studies, LTD, LLP | Houston | Texas | 77004 | United States |
| Dermatology Clinical Research Center of San Antonio | San Antonio | Texas | 78229 | United States |
| Progressive Clinical Reesearch, PA | San Antonio | Texas | 78229 | United States |
| Charlottesville Medical Research Center, LLC | Charlottesville | Virginia | 22911 | United States |
| Eastern Washington Dermatology | Walla Walla | Washington | 99362 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | DFD01 Spray | DFD01 Spray twice daily DFD01 Spray |
| BG001 | Vehicle Spray | Vehicle Spray twice daily Vehicle Spray |
| BG002 | 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 |
| ||||||||||||||||
| % Body Surface Area | Mean | Standard Deviation | Percent |
| |||||||||||||||
| Participants with Moderate Psoriasis According to the Investigator's Global Assessment (IGA) | Count of Participants | Participants |
|
| 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 Treatment Success According to the Investigator's Global Assessment (IGA) | IGA of clear or almost clear | Intent to Treat | Posted | Number | 95% Confidence Interval | percentage of subjects | Day 15 |
|
|
|
Not provided
Three subjects in the betamethasone dipropionate spray 0.05% group and two subjects in the vehicle spray group had no post-baseline safety evaluations.
Not provided
| 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 DFD01 Spray | 1 | 179 | 17 | 179 | ||
| EG001 | Vehicle Spray | Vehicle Spray twice daily Vehicle Spray | 2 | 93 | 24 | 93 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper Gastrointestinal Bleed | Gastrointestinal disorders |
| |||
| Infection Right Foot | Infections and infestations |
| |||
| Exacerbation of Schizophrenia | Psychiatric disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application Site Pain | General disorders |
| |||
| Application Site Pruritus | General disorders |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Operations | Promius Pharma | 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 |
Not provided
Not provided
| Male |
|