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This study will be conducted to evaluate the therapeutic bioequivalence of a TEST formulation of calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064% to the RLD.
Randomized, Double-Blind, Placebo-Controlled, Multiple-Site, Parallel Design, Bioequivalence with Clinical Endpoints.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Calcipotriene Hydrate and Betamethasone | Experimental | Calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064% |
|
| Taclonex | Active Comparator | Calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064% |
|
| Placebo | Placebo Comparator | Topical suspension without active ingredient |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcipotriene and betamethasone suspension | Drug | Calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064% |
|
| Measure | Description | Time Frame |
|---|---|---|
| Psoriasis Area Severity Index (PASI) | To evaluate the change in clinical outcome of patients exposed to Calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064%, Taclonex and Vehicle for scalp psoriasis. From baseline to end of study. | at Day 1, Day 28 |
| Physician Global Assessment (PGA) | To evaluate the change in global severity of skin of patients exposed to Calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064%, Taclonex, and Vehicle for scalp psoriasis. From baseline to end of study. | at Day 1, Day 28 |
| Body Surface Area (BSA) | To evaluate the total body area of skin affected by psoriasis. | at Day 1 |
| Adverse Events and Serious Adverse Events | Risk for adverse events and serious adverse events for exposed to Calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064%, Taclonex and Vehicle for scalp psoriasis | at Day 28 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jim Joffrion | Catawba Research | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 17 | Hot Springs | Arkansas | 71913 | United States | ||
| Site 29 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 8, 2020 | |
| Reset | Oct 29, 2020 | |
| Release | Apr 5, 2021 |
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|
| Taclonex | Drug | Calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064% |
|
|
| Placebo | Drug | vehicle used as placebo |
|
|
| Fremont |
| California |
| 94538 |
| United States |
| Site 12 | Los Angeles | California | 90036 | United States |
| Site 18 | Sherman Oaks | California | 91403 | United States |
| Site 34 | Denver | Colorado | 80220 | United States |
| Site 20 | Boca Raton | Florida | 33486 | United States |
| Site 01 | Brandon | Florida | 33511 | United States |
| Site 25 | Coral Gables | Florida | 33134 | United States |
| Site 11 | Hialeah | Florida | 33012 | United States |
| Site 26 | Miami | Florida | 33126 | United States |
| Site 04 | Miami | Florida | 33175 | United States |
| Site 05 | Miramar | Florida | 33027 | United States |
| Site 02 | Tampa | Florida | 33609 | United States |
| Site 03 | Tampa | Florida | 33618 | United States |
| Site 23 | Winter Park | Florida | 32792 | United States |
| Site 16 | Plainfield | Indiana | 46168 | United States |
| Site 19 | Olathe | Kansas | 66061 | United States |
| Site 33 | Lake Charles | Louisiana | 70601 | United States |
| Site 27 | Saint Joseph | Missouri | 64506 | United States |
| Site 14 | Las Vegas | Nevada | 89106 | United States |
| Site 09 | High Point | North Carolina | 27262 | United States |
| Site 28 | Hazleton | Pennsylvania | 18201 | United States |
| Site 24 | Upper Saint Clair | Pennsylvania | 15241 | United States |
| Site 32 | Johnston | Rhode Island | 02919 | United States |
| Site 07 | Anderson | South Carolina | 29621 | United States |
| Site 35 | Mt. Pleasant | South Carolina | 29464 | United States |
| Site 21 | Austin | Texas | 78759 | United States |
| Site 06 | Dallas | Texas | 75234 | United States |
| Site 30 | El Paso | Texas | 79902 | United States |
| Site 08 | Murphy | Texas | 75094 | United States |
| Site 15 | San Antonio | Texas | 78229 | United States |
| Site 31 | San Antonio | Texas | 78229 | United States |
| Site 10 | Salt Lake City | Utah | 84117 | United States |
| Site 22 | Norfolk | Virginia | 23507 | United States |
| Reset | Apr 29, 2021 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 8, 2020 | Oct 29, 2020 | |||
| Apr 5, 2021 | Apr 29, 2021 |
| ID | Term |
|---|---|
| C055085 | calcipotriene |
| D001623 | Betamethasone |
| C517164 | betamethasone dipropionate, calcipotriol drug combination |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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