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This is a phase III, randomized, double-blind, placebo-controlled, parallel- group, multiple-site study to evaluate the therapeutic equivalence of generic calcipotriene and betamethasone dipropionate topical suspension, 0.005%/0.064% of Glenmark Pharmaceuticals Ltd to that of the marketed product Taclonex® topical suspension of Leo Pharma Inc. in the treatment of scalp psoriasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Calcipotriene/betamethasone dipropionate | Experimental |
| |
| Taclonex® | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcipotriene/Betamethasone Dipropionate | Drug | Topical suspension 0.005%/0.064% (Glenmark Pharmaceuticals Ltd) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects in each treatment group with treatment success, defined as a score of 0 or 1, within the treatment area(s) on the PGA scale of disease severity, at the end of study visit. | Day 29 | |
| Proportion of subjects in each treatment group with clinical success, defined as a score of 0 or 1, at the target lesion site on the PASI scale at the end of study visit. | Day 29 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William Todd Kays | Glenmark Pharmaceuticals Inc., USA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site 24 | Encinitas | California | 92024 | United States | ||
| Investigational Site 3 |
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| Taclonex® | Drug | Calcipotriene/ betamethasone dipropionate topical suspension, 0.005%/0.064% (LEO Pharma Inc.) |
|
| Placebo | Drug | Placebo of Calcipotriene/ betamethasone dipropionate topical suspension, 0.005%/0.064% (Glenmark Pharmaceuticals Ltd.) |
|
| Fremont |
| California |
| 94538 |
| United States |
| Investigational Site 13 | San Diego | California | 92108 | United States |
| Investigational Site 20 | San Diego | California | 92123 | United States |
| Investigational Site 32 | Santa Monica | California | 90404 | United States |
| Investigational Site 14 | Denver | Colorado | 80220 | United States |
| Investigational Site 1 | Miami | Florida | 33144 | United States |
| Investigational Site 30 | Miami | Florida | 33175 | United States |
| Investigational Site 7 | Miramar | Florida | 33027 | United States |
| Investigational Site 22 | Tampa | Florida | 33609 | United States |
| Investigational Site 15 | New Albany | Indiana | 47150 | United States |
| Investigational Site 10 | South Bend | Indiana | 46617 | United States |
| Investigational Site 21 | Louisville | Kentucky | 40241 | United States |
| Investigational Site 6 | Ann Arbor | Michigan | 48103 | United States |
| Investigational Site 12 | Fridley | Minnesota | 55432 | United States |
| Investigational Site 26 | Saint Joseph | Missouri | 64506 | United States |
| Investigational Site 17 | Henderson | Nevada | 89052 | United States |
| Investigational Site 25 | Las Vegas | Nevada | 89128 | United States |
| Investigational Site 29 | Forest Hills | New York | 11375 | United States |
| Investigational Site 28 | Rochester | New York | 14623 | United States |
| Investigational Site 4 | High Point | North Carolina | 27262 | United States |
| Investigational Site 18 | Fountain Inn | South Carolina | 29644 | United States |
| Investigational Site 27 | Mt. Pleasant | South Carolina | 29464 | United States |
| Investigational Site 9 | Knoxville | Tennessee | 37922 | United States |
| Investigational Site 8 | Nashville | Tennessee | 37215 | United States |
| Investigational Site 5 | Austin | Texas | 78759 | United States |
| Investigational Site 11 | College Station | Texas | 77845 | United States |
| Investigational Site 16 | San Antonio | Texas | 78213 | United States |
| Investigational Site 19 | San Antonio | Texas | 78249 | United States |
| Investigational Site 31 | Norfolk | Virginia | 23507 | United States |
| Investigational Site 23 | Richmond | Virginia | 23294 | United States |
| ID | Term |
|---|---|
| C517164 | betamethasone dipropionate, calcipotriol drug combination |
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