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| Name | Class |
|---|---|
| Prosoft Clinical | OTHER |
The purpose of this study is to evaluate the potential of DFD01 spray to suppress the HPA (hypothalamic-pituitary-adrenal) axis as compared to Comp01 lotion when applied twice daily for 15 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DFD01 Spray Group 1 | Experimental | DFD01 Spray, bid, 28 days |
|
| Comp01 Lotion | Active Comparator | Comp01 Lotion, bid, 14 days |
|
| DFD01 Spray Group 2 | Experimental | DFD01 Spray, bid, 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DFD01 Spray | Drug |
| ||
| Comp01 Lotion |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Subjects With HPA Axis Suppression | Day 15 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Dermatology and Clinical Research Institute | Encinitas | California | 92024 | United States | ||
| 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 Group 1 | DFD01 Spray, bid, 28 days DFD01 Spray |
| FG001 | Comp01 Lotion | Comp01 Lotion, bid, 14 days Comp01 Lotion |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
|
| Encino Research Center T. Joseph Raoof MD, Inc. |
| Encino |
| California |
| 91436 |
| United States |
| Redwood Dermatology Research | Santa Rosa | California | 95403 | United States |
| Bettencourt Skin Center | Henderson | Nevada | 89074 | United States |
| Academic Dermatology Associates | Albuquerque | New Mexico | 87106 | United States |
| Dermatology Consulting Services | High Point | North Carolina | 27262 | United States |
| Paddington Testing Company, Inc. | Philadelphia | Pennsylvania | 19101 | United States |
| Tennessee Clinical Research Center | Nashville | Tennessee | 37215 | United States |
| DermResearch, Inc. | Austin | Texas | 78759 | United States |
| Center for Clinical Studies, LTD. LLP | Houston | Texas | 77004 | United States |
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| Suzanne Bruce and Associates, PA The Center for Skin Research Katy/Cinco Ranch | Katy | Texas | 77494 | United States |
| FG002 | DFD01 Spray Group 2 | DFD01 Spray, bid, 14 days DFD01 Spray |
| COMPLETED |
|
| NOT COMPLETED |
|
|
One subject signed informed consent and was randomized but was lost to follow up and, therefore, provided no baseline or post-baseline data.
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| ID | Title | Description |
|---|---|---|
| BG000 | DFD01 Spray Group 1 | DFD01 Spray, bid, 28 days DFD01 Spray |
| BG001 | Comp01 Lotion | Comp01 Lotion, bid, 14 days Comp01 Lotion |
| BG002 | DFD01 Spray Group 2 | DFD01 Spray, bid, 14 days DFD01 Spray |
| BG003 | 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 |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||
| Percent Body Surface Area (BSA) involved | Mean | Standard Deviation | Percent BSA affected |
| |||||||||||||||
| Investigator's Global Assessment (IGA) | Count of Participants | Participants |
| ||||||||||||||||
| Normal Adrenal Corticotropic Hormone (ACTH) test | 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 | The Number of Subjects With HPA Axis Suppression | Three subjects in the 28 day DFD01 Treatment Group, three subjects in the 14 day Comp01 Treatment Group, and one subject in the 14 day DFD01 Treatment Group did not have ACTH stimulation test results. | Posted | Count of Participants | Participants | Day 15 |
|
|
|
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One subject signed informed consent and was randomized but was lost to follow up and, therefore, provided no baseline or post-baseline data.
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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 Group 1 | DFD01 Spray, bid, 28 days DFD01 Spray | 0 | 27 | 2 | 27 | ||
| EG001 | Comp01 Lotion | Comp01 Lotion, bid, 14 days Comp01 Lotion | 0 | 22 | 6 | 22 | ||
| EG002 | DFD01 Spray Group 2 | DFD01 Spray, bid, 14 days DFD01 Spray | 0 | 25 | 8 | 25 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| HPA Axis Suppression | Endocrine disorders |
| |||
| Application Site Pruritus | General disorders |
| |||
| Headache | Nervous system disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Operations | Promius Pharma, LLC | 609-282-1476 | kgulbronson@promiuspharma.com |
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| IGA 4 (Severe/Very Severe) |
|