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| ID | Type | Description | Link |
|---|---|---|---|
| U0267-301 | Other Identifier | Stiefel |
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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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The purpose of the study is to demonstrate the safety and efficacy of U0267 in subjects with plaque-type psoriasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| U0267 Foam | Experimental | U0267 is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body. |
|
| Vehicle foam | Placebo Comparator | Vehicle foam is the same as the U0267 foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| U0267 | Drug | All treatments will be administered topically twice daily (morning and evening) for 8 weeks to areas affected with psoriasis (excluding face and scalp). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Treatment Success, Assessed Per the Investigator's Static Global Assessment (ISGA) | Assessment (on a scale of 0 to 4) was made as a visual average of all lesions, except those on the face/scalp. 0=clear; minor residual discoloration; no erythema/scaling/plaque thickness (PT). 1=almost clear; occasional fine scale/faint erythema/barely perceptible PT. 2=mild; fine scales predominate; light red coloration/mild PT. 3=moderate; coarse scales predominate; moderate red coloration/moderate PT. 4=severe; thick tenacious scale predominates; deep red coloration/severe PT. Treatment success=ISGA score 0 or 1, and a minimum improvement in the ISGA score of 2 grades from BL to week 8. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With a Target Lesion Score of 0 or 1 for Erythema and at Least a 2-grade Improvement From Baseline at Week 8 | Erythema was assessed on a 6-point scale. 0=no evidence of erythema; hyperpigmentation may be present. 1=faint erythema. 2=light red coloration. 3=moderate red coloration. 4=bright red coloration. 5=dusky to deep red coloration. | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Therapeutics Clinical Research Center, Inc. | San Diego | California | 92123 | United States | ||
| Cherry Creek Research, Inc. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22587791 | Derived | Feldman SR, Matheson R, Bruce S, Grande K, Markowitz O, Kempers S, Brundage T, Wyres M; U0267-301 & 302 Study Investigators. Efficacy and safety of calcipotriene 0.005% foam for the treatment of plaque-type psoriasis: results of two multicenter, randomized, double-blind, vehicle-controlled, phase III clinical trials. Am J Clin Dermatol. 2012 Aug 1;13(4):261-71. doi: 10.2165/11630710-000000000-00000. |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 114741 | Study Protocol | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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| ID | Title | Description |
|---|---|---|
| FG000 | Calcipotriene Foam | Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body. |
| FG001 | Vehicle Foam |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Vehicle | Drug | All treatments will be administered topically twice daily (morning and evening) for 8 weeks to areas affected with psoriasis (excluding face and scalp). |
|
| Number of Subjects With a Target Lesion Score of 0 or 1 for Scaling and at Least a 2 Grade Improvement From Baseline at Week 8 | Scaling was assessed on a 6-point scale. 0=no evidence of scaling. 1=minimal; occasional fine scale over less than 5% of the lesion. 2=mild, fine scales predominate. 3=moderate; course scales predominate. 4=marked; thick non-tenacious scale predominates. 5=severe; very thick tenacious scale predominates. | 8 weeks |
| Number of Subjects With a Target Lesion Score of 0 for Plaque Thickness at Week 8 | Plaque thickness was assessed on a 6-point scale. 0=no evidence of plaque thickness. 1=barely perceptible plaque thickness, approximately 0.5 millimeters (mm). 2=mild plaque thickness, approximately 1 mm. 3=moderate plaque thickness, approximately 1.5 mm. 4=marked plaque thickness, approximately 2 mm. 5=severe plaque thickness, approximately 2.5 mm or more. | 8 weeks |
| Number of Subjects Who Have an ISGA Score of 0 or 1 at Week 8 | Assessment (on a scale of 0 to 4) was made as a visual average of all lesions, except those on the face/scalp. 0=clear; minor residual discoloration; no erythema/scaling/plaque thickness (PT). 1=almost clear; occasional fine scale/faint erythema/barely perceptible PT. 2=mild; fine scales predominate; light red coloration/mild PT. 3=moderate; coarse scales predominate; moderate red coloration/moderate PT. 4=severe; thick tenacious scale predominates; deep red coloration/severe PT. | 8 weeks |
| Number of Subjects Who Have Treatment Success at Week 8 Analyzed by Baseline ISGA (Mild or Moderate) | Assessment (on a scale of 0 to 4) was made as a visual average of all lesions, except those on the face/scalp. 0=clear; minor residual discoloration; no erythema/scaling/plaque thickness (PT). 1=almost clear; occasional fine scale/faint erythema/barely perceptible PT. 2=mild; fine scales predominate; light red coloration/mild PT. 3=moderate; coarse scales predominate; moderate red coloration/moderate PT. 4=severe; thick tenacious scale predominates; deep red coloration/severe PT. Treatment success=ISGA score 0 or 1, and a minimum improvement in the ISGA score of 2 grades from BL to week 8. | 8 weeks |
| Denver |
| Colorado |
| 80209 |
| United States |
| Florida Academic Dermatology Centers | Miami | Florida | 33136 | United States |
| FXM Research | Miami | Florida | 33175 | United States |
| DermResearch, PLLC | Louisville | Kentucky | 40217 | United States |
| Massachusetts General Hospital Clinical Unit for Research Trials in Skin | Boston | Massachusetts | 02114 | United States |
| Minnesota Clinical Study Center | Fridley | Minnesota | 55432 | United States |
| Mount Sinai School of Medicine, Department of Dermatology | New York | New York | 10029 | United States |
| Dermatology Consulting Services | High Point | North Carolina | 27262 | United States |
| Oregon Medical Research Center, P.C. | Portland | Oregon | 97223 | United States |
| Dermatology Treatment & Research Center | Dallas | Texas | 75230 | United States |
| The Center for Skin Research | Houston | Texas | 77056 | United States |
| Dermatology Research Center, Inc. | Salt Lake City | Utah | 84124 | United States |
For additional information about this study please refer to the GSK Clinical Study Register |
| 114741 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114741 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114741 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114741 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114741 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114741 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Calcipotriene Foam | Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body. |
| BG001 | Vehicle Foam | Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Number | participants |
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| Gender | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Disease Characteristic - Erythema | Disease characteristics of Erythema at baseline | Number | participants |
| |||||||||||||||
| Disease Characteristic - Scaling | Disease characteristics of Scaling at baseline | Number | participants |
| |||||||||||||||
| Disease Characteristic - Plaque Thickness | Disease characteristics of Plaque Thickness at baseline | Number | participants |
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| Disease Characteristic- Target Lesion Location | Disease characteristics of Target Lesion Location at baseline | Number | participants |
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| Disease Characteristic - Investigator's Static Global Assessment | Disease characteristics of Investigator's Static Global Assessment at baseline | Number | participants |
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| Disease Characteristic - Subject's Global Assessment | Disease characteristics of Subject's Global Assessment at baseline | Number | participants |
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| Disease Characteristic - Percent BSA (extent of psoriasis) | Disease characteristics of BSA (extent of psoriasis) at baseline | Mean | Standard Deviation | percent of body surface |
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| 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 | Number of Subjects With Treatment Success, Assessed Per the Investigator's Static Global Assessment (ISGA) | Assessment (on a scale of 0 to 4) was made as a visual average of all lesions, except those on the face/scalp. 0=clear; minor residual discoloration; no erythema/scaling/plaque thickness (PT). 1=almost clear; occasional fine scale/faint erythema/barely perceptible PT. 2=mild; fine scales predominate; light red coloration/mild PT. 3=moderate; coarse scales predominate; moderate red coloration/moderate PT. 4=severe; thick tenacious scale predominates; deep red coloration/severe PT. Treatment success=ISGA score 0 or 1, and a minimum improvement in the ISGA score of 2 grades from BL to week 8. | Intent-to-Treat (ITT) Population | Posted | Number | particpants | 8 weeks |
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| Secondary | Number of Subjects With a Target Lesion Score of 0 or 1 for Erythema and at Least a 2-grade Improvement From Baseline at Week 8 | Erythema was assessed on a 6-point scale. 0=no evidence of erythema; hyperpigmentation may be present. 1=faint erythema. 2=light red coloration. 3=moderate red coloration. 4=bright red coloration. 5=dusky to deep red coloration. | ITT | Posted | Number | participants | 8 weeks |
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| Secondary | Number of Subjects With a Target Lesion Score of 0 or 1 for Scaling and at Least a 2 Grade Improvement From Baseline at Week 8 | Scaling was assessed on a 6-point scale. 0=no evidence of scaling. 1=minimal; occasional fine scale over less than 5% of the lesion. 2=mild, fine scales predominate. 3=moderate; course scales predominate. 4=marked; thick non-tenacious scale predominates. 5=severe; very thick tenacious scale predominates. | ITT | Posted | Number | participants | 8 weeks |
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| Secondary | Number of Subjects With a Target Lesion Score of 0 for Plaque Thickness at Week 8 | Plaque thickness was assessed on a 6-point scale. 0=no evidence of plaque thickness. 1=barely perceptible plaque thickness, approximately 0.5 millimeters (mm). 2=mild plaque thickness, approximately 1 mm. 3=moderate plaque thickness, approximately 1.5 mm. 4=marked plaque thickness, approximately 2 mm. 5=severe plaque thickness, approximately 2.5 mm or more. | ITT | Posted | Number | participants | 8 weeks |
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| Secondary | Number of Subjects Who Have an ISGA Score of 0 or 1 at Week 8 | Assessment (on a scale of 0 to 4) was made as a visual average of all lesions, except those on the face/scalp. 0=clear; minor residual discoloration; no erythema/scaling/plaque thickness (PT). 1=almost clear; occasional fine scale/faint erythema/barely perceptible PT. 2=mild; fine scales predominate; light red coloration/mild PT. 3=moderate; coarse scales predominate; moderate red coloration/moderate PT. 4=severe; thick tenacious scale predominates; deep red coloration/severe PT. | ITT | Posted | Number | participants | 8 weeks |
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| Secondary | Number of Subjects Who Have Treatment Success at Week 8 Analyzed by Baseline ISGA (Mild or Moderate) | Assessment (on a scale of 0 to 4) was made as a visual average of all lesions, except those on the face/scalp. 0=clear; minor residual discoloration; no erythema/scaling/plaque thickness (PT). 1=almost clear; occasional fine scale/faint erythema/barely perceptible PT. 2=mild; fine scales predominate; light red coloration/mild PT. 3=moderate; coarse scales predominate; moderate red coloration/moderate PT. 4=severe; thick tenacious scale predominates; deep red coloration/severe PT. Treatment success=ISGA score 0 or 1, and a minimum improvement in the ISGA score of 2 grades from BL to week 8. | ITT | Posted | Number | participants | 8 weeks |
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Baseline through week 8
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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 | Calcipotriene Foam | Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body. | 1 | 223 | 0 | 223 | ||
| EG001 | Vehicle Foam | Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body. | 1 | 113 | 0 | 113 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA version 11 | Non-systematic Assessment |
| |
| Cadiac failure congestive | Cardiac disorders | MedDRA version 11.0 | Non-systematic Assessment |
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| Intestinal obstruction | Gastrointestinal disorders | MedDRA version 11.0 | Non-systematic Assessment |
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GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| 18 to <65 years |
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| > 65 years |
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| Male |
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| Asian |
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| Black |
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| Multiracial |
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| Native Hawaiian or Other Pacific Islander |
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| White |
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| Missing |
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| Moderate red coloration |
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| Bright red coloration |
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| Moderate |
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| Marked |
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| Moderate elevation |
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| Leg |
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| Trunk |
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| Moderate |
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| Almost Clear |
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| Mild |
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| Moderate |
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| Very Noticeable |
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| Severe |
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| Breslow-Day Test |
Breslow-Day test of the homogeneity of the odds ratio using a 0.1 significance level. |
| 0.313 |
| No |
| Superiority or Other |
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| Participants |
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