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Not able to recruit patients with the current enrollment criteria.
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| Name | Class |
|---|---|
| Prosoft Clinical | OTHER |
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To evaluate the potential of DFD-01 (betamethasone dipropionate) Spray, 0.05% to suppress the hypothalamic-pituitary-adrenal (HPA) axis.
To evaluate the potential of DFD-01 (betamethasone dipropionate) Spray, 0.05% to suppress the hypothalamic-pituitary-adrenal (HPA) axis when applied twice daily for 15 days or when applied twice daily for 29 days, in adolescent subjects with moderate to severe plaque psoriasis under maximal use conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DFD01 Spray Group 1 | Experimental | DFD01 spray, twice daily, 15 days |
|
| DFD01 Spray Group 2 | Experimental | DFD01 spray, twice daily, 29 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DFD01 Spray | Drug | DFD-01 (betamethasone dipropionate) Spray, 0.05% |
|
| Measure | Description | Time Frame |
|---|---|---|
| Participants With HPA Axis Suppression at End of Treatment (Day 15 or Day 28) With Recovery 29 Days Later | Number of participants with HPA axis suppression at End of Treatment (day 15 or day 28) with recovery 29 days later, by measuring the level of cortisol in the blood after ACTH stimulation test | End of Treatment (day 15 or day 28) with recovery 29 days later |
| Participants With HPA Axis Suppression at Day 29 | Number of participants with HPA axis suppression at Day 29, by measuring the level of cortisol in the blood after ACTH stimulation test | Day 29 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Srinivas Sidgiddi, MD | Dr. Reddy's Laboratories, Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 102 | Encino | California | 91436 | United States | ||
| Site 104 |
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| ID | Title | Description |
|---|---|---|
| FG000 | DFD01 Spray Group 1 | DFD01 spray, twice daily, 15 days DFD01 Spray: DFD-01 (betamethasone dipropionate) Spray, 0.05% |
| FG001 | DFD01 Spray Group 2 | DFD01 spray, twice daily, 29 days DFD01 Spray: DFD-01 (betamethasone dipropionate) Spray, 0.05% |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 13, 2017 |
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| Irvine |
| California |
| 92697-1385 |
| United States |
| Site 100 | San Diego | California | 92123 | United States |
| Site 109 | Lebanon | New Hampshire | 03756 | United States |
| Site 107 | New York | New York | 10155 | United States |
| Site 106 | Arlington | Texas | 76014 | United States |
| Site 101 | Houston | Texas | 77030 | United States |
| Site 105 | San Antonio | Texas | 78218 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | DFD01 Spray Group 1 | DFD01 spray, twice daily, 15 days DFD01 Spray: DFD-01 (betamethasone dipropionate) Spray, 0.05% |
| BG001 | DFD01 Spray Group 2 | DFD01 spray, twice daily, 29 days DFD01 Spray: DFD-01 (betamethasone dipropionate) Spray, 0.05% |
| 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | 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 | Participants With HPA Axis Suppression at End of Treatment (Day 15 or Day 28) With Recovery 29 Days Later | Number of participants with HPA axis suppression at End of Treatment (day 15 or day 28) with recovery 29 days later, by measuring the level of cortisol in the blood after ACTH stimulation test | Subjects who completed the treatment period | Posted | Count of Participants | Participants | End of Treatment (day 15 or day 28) with recovery 29 days later |
|
|
| |||||||||||||||||||||||||||||
| Primary | Participants With HPA Axis Suppression at Day 29 | Number of participants with HPA axis suppression at Day 29, by measuring the level of cortisol in the blood after ACTH stimulation test | Posted | Count of Participants | Participants | Day 29 |
|
|
43 days (14-day treatment group) or 57 days (29-day treatment group)
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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, twice daily, 15 days DFD01 Spray: DFD-01 (betamethasone dipropionate) Spray, 0.05% | 0 | 2 | 0 | 2 | 1 | 2 |
| EG001 | DFD01 Spray Group 2 | DFD01 spray, twice daily, 29 days DFD01 Spray: DFD-01 (betamethasone dipropionate) Spray, 0.05% | 0 | 1 | 0 | 1 | 1 | 1 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| HPA Axis suppression | Endocrine disorders | MedDRA | Systematic Assessment |
|
No report, abstract, oral presentation, or publication of the results of the Study proposed by Institution shall be presented or published without the prior written consent of the Sponsor or as otherwise permitted for regulatory agency inspections.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Babilon President | Prosoft Clinical | 484 320 2068 | b.babilon@prosoftclinical.com |
| Aug 29, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001623 | Betamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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| >=65 years |
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| Male |
|
| Not Hispanic or Latino |
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| Unknown or Not Reported |
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|