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| ID | Type | Description | Link |
|---|---|---|---|
| U0267-303 | Other Identifier | Stiefel |
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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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The purpose of this study is to determine the safety and effectiveness in the treatment of psoriasis on the scalp and on the body.
The study subjects must have moderate psoriasis of the body and scalp with an ISGA of 3 at baseline. In addition, the subjects must have an evaluable target lesion of at least 2 cm² on the body with a score of 2 or 3 for erythema, scaling and plaque. All subjects will apply Calcipotriene Foam, 0.005% or vehicle foam topically twice a day (am and pm) to all psoriatic lesions on the body and scalp. Study visits will occur at baseline (day 1) and at weeks 1, 2, 4, and 8.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Calcipotriene Foam | Experimental | Calcipotriene Foam 0.005%, |
|
| Vehicle Foam | Placebo Comparator | Vehicle Foam |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcipotriene Foam | Drug | Calcipotriene Foam 0.005%. All treatments will be administered to the skin twice daily (am-pm) for 8 weeks for subjects in this group |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With an Investigator's Static Global Assessment (ISGA) Score of Clear (0) or Almost Clear (1) for Scalp Involvement at Week 8 Using the Failure Method | The investigator assessed participants with scalp psoriasis using the ISGA, scored as (as a visual average of lesions): 0, absence of disease; 1, very mild disease, lesions (L) with minimum erythema; 2, mild disease, L with light-red coloration, slight thickness, and fine, thin scale layer; 3, moderate disease, L with red coloration, moderate thickness, and a moderate scaled layer; 4, severe disease, L with red coloration, severe thickness, and a severe coarse, thick scale layer; 5, very severe disease, L with red coloration, very severe thickness, and a very severe, coarse, thick scale layer. | Week 8 |
| Number of Participants With an ISGA Score of Clear (0) or Almost Clear (1) for Scalp Involvement at Week 8 Using Last Observation Carried Forward (LOCF) | The investigator assessed participants with scalp psoriasis using the ISGA, scored as (as a visual average of lesions): 0, absence of disease; 1, very mild disease, lesions (L) with minimum erythema; 2, mild disease, L with light-red coloration, slight thickness, and fine, thin scale layer; 3, moderate disease, L with red coloration, moderate thickness, and a moderate scaled layer; 4, severe disease, L with red coloration, severe thickness, and a severe coarse, thick scale layer; 5, very severe disease, L with red coloration, very severe thickness, and a very severe, coarse, thick scale layer. | Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Target Lesion Score of 0 or 1 for Erythema and at Least a 2 Grade Improvement From Baseline at Week 8 | Erythema is redness of the skin, caused by increased blood flow in the capillaries in the lower layers of the skin. The investigator assessed participants with erythema at target lesions using the psoriasis grading scale for target lesions (PGSTL). PGSTL scores: 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. |
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Inclusion Criteria:
Capable of understanding and willing to provide signed and dated written voluntary informed consent (and any local or national authorization requirements) before any protocol-specific procedures are performed.
Male or female subjects at least 12 years old and in good general health.
Able to complete the study and to comply with study instructions.
Moderate plaque-type psoriasis on the body (excluding the scalp and face) defined as:
Involvement of at least 10% of the total scalp surface area with clinical signs (erythema, thickness, and scaliness) rated as moderate (3) based on the ISGA.
Negative urine pregnancy test for females of childbearing potential. • Sexually active females of childbearing potential participating in the study must agree to use a medically acceptable method of contraception while receiving protocol-assigned product. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant; including perimenopausal women who are fewer than 2 years from their last menses.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Genova Clinical Research | Tucson | Arizona | 85791 | United States | ||
| Therapeutics Clinical Research Center, Inc. |
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| 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 |
|---|---|---|---|
| 114743 | Dataset Specification | 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 0.005% was applied to the affected area(s) on the scalp and body twice daily (BD) for 8 weeks. |
| FG001 | Vehicle Foam | Vehicle foam was applied to the affected area(s) on the scalp and body BD for 8 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Vehicle Foam | Drug | Vehicle Foam. All treatments will be administered to the skin twice daily (am-pm) for 8 weeks for subjects in this group |
|
| Baseline and Week 8 |
| Number of Participants With a Target Lesion Score of 0 or 1 for Scaling and at Least a 2 Grade Improvement From Baseline at Week 8 | Scaling of the skin is the loss of the outer layer of the epidermis in scale-like flakes. The investigator assessed participants with scaling at target lesions using the psoriasis grading scale for target lesions (PGSTL). PGSTL scores: 0, no evidence of scaling; 1, minimal, occasional fine scale over less than 5% of the lesion; 2, mild, fine scales predominate; 3, moderate, coarse scales predominate; 4 marked, thick non-tenacious scale predominates; 5 severe, very thick tenacious scale predominates. | Baseline and Week 8 |
| Number of Participants With a Target Lesion Score of 0 or 1 for Plaque Thickness at Week 8 | Psoriasis is a noncontagious skin disorder, most often appearing as inflamed, thickened skin covered with silvery white scales on the scalp, trunk, and limbs. The investigator assessed participants with plaque thickness at target lesions using the PGSTL scores: 0, no elevation over normal skin; 1, possible but difficult to ascertain whether there is a slight elevation above normal skin; 2, slight but definite elevation, edges are indistinct or sloped; 3, moderate elevation with rough or sloped edges; 4, marked elevation with hard or sharp edges; 5, very marked elevation with hard sharp edges. | Baseline and Week 8 |
| Number of Participants With an ISGA Score of Clear (0) or Almost Clear (1) for Body Involvement at Week 8 | The investigator assessed participants with psoriasis with body involvement using the ISGA, scored as: 0, clear, minor residual discoloration, no erythema, scaling, or plaque thickness; 1, almost clear, occasional fine scale, faint erythema, and barely perceptible plaque thickness; 2, mild, fine scales predominate with light-red coloration and mild plaque thickness; 3, moderate, coarse scales predominate with moderate red coloration and plaque thickness; 4 severe, thick tenacious scale predominates with deep red coloration and severe plaque thickness. Scores are a visual average of lesions. | Week 8 |
| San Diego |
| California |
| 92123 |
| United States |
| Cherry Creek Research, Inc. | Denver | Colorado | 80209 | United States |
| Miami Dermatology Research Institute LLC | North Miami Beach | Florida | 33169 | United States |
| MedaPhase, Inc. | Newnan | Georgia | 30263 | United States |
| Gwinnett Clinical Research Center, Inc. | Snellville | Georgia | 30078 | United States |
| Dermatology Specialists | Louisville | Kentucky | 40202 | United States |
| DermResearch, PLLC | Louisville | Kentucky | 40217 | United States |
| Henry Ford Medical Center | Detroit | Michigan | 48202 | United States |
| Grekin Skin Institute | Warren | Michigan | 48088 | United States |
| Minnesota Clinical Study Center | Fridley | Minnesota | 55432 | United States |
| Central Dermatology PC | St Louis | Missouri | 63117 | United States |
| Mt. Sinai School of Medicine Div. Dermatologic & Cosmetic Surgery | New York | New York | 10029 | United States |
| Dermatology Associates of Rochester, PC | Rochester | New York | 14623 | United States |
| Dermatology Consulting Services | High Point | North Carolina | 27262 | United States |
| Wake Forest University Health Sciences Department of Dermatology | Winston-Salem | North Carolina | 27157 | United States |
| Group Health Associates | Cincinnatti | Ohio | 45220 | United States |
| Oregon Medical | Portland | Oregon | 97223 | United States |
| Coastal Carolina Research Center | Mt. Pleasant | South Carolina | 29464 | United States |
| The Skin Wellness Center, PC | Knoxville | Tennessee | 37922 | United States |
| Tennessee Clinical Research | Nashville | Tennessee | 37215 | United States |
| DermReserach, Inc. | Austin | Texas | 78759 | United States |
| Suzanne Bruce and Associates, PA | Houston | Texas | 77056 | United States |
| Dermatology Clinical Research Center of San Antonio | San Antonio | Texas | 78229 | United States |
| Dermatology Research Center, Inc. | Salt Lake City | Utah | 84124 | United States |
| Education and Research Foundation | Lynchburg | Virginia | 24501 | United States |
For additional information about this study please refer to the GSK Clinical Study Register |
| 114743 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114743 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114743 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114743 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114743 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114743 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Calcipotriene Foam | Calcipotriene foam 0.005% was applied to the affected area(s) on the scalp and body BD for 8 weeks. |
| BG001 | Vehicle Foam | Vehicle foam was applied to the affected area(s) on the scalp and body BD for 8 weeks. |
| 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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| Gender | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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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 Participants With an Investigator's Static Global Assessment (ISGA) Score of Clear (0) or Almost Clear (1) for Scalp Involvement at Week 8 Using the Failure Method | The investigator assessed participants with scalp psoriasis using the ISGA, scored as (as a visual average of lesions): 0, absence of disease; 1, very mild disease, lesions (L) with minimum erythema; 2, mild disease, L with light-red coloration, slight thickness, and fine, thin scale layer; 3, moderate disease, L with red coloration, moderate thickness, and a moderate scaled layer; 4, severe disease, L with red coloration, severe thickness, and a severe coarse, thick scale layer; 5, very severe disease, L with red coloration, very severe thickness, and a very severe, coarse, thick scale layer. | Intent-to-Treat (ITT) Population: all participants who were randomized and dispensed study product. Missing values at Week 8 were considered to be failures. Failures were those participants who did not achieve a 2-grade improvement in IGSA score and a score of 0 or 1. | Posted | Number | participants | Week 8 |
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| Secondary | Number of Participants With a Target Lesion Score of 0 or 1 for Erythema and at Least a 2 Grade Improvement From Baseline at Week 8 | Erythema is redness of the skin, caused by increased blood flow in the capillaries in the lower layers of the skin. The investigator assessed participants with erythema at target lesions using the psoriasis grading scale for target lesions (PGSTL). PGSTL scores: 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 Population | Posted | Number | participants | Baseline and Week 8 |
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| Secondary | Number of Participants With a Target Lesion Score of 0 or 1 for Scaling and at Least a 2 Grade Improvement From Baseline at Week 8 | Scaling of the skin is the loss of the outer layer of the epidermis in scale-like flakes. The investigator assessed participants with scaling at target lesions using the psoriasis grading scale for target lesions (PGSTL). PGSTL scores: 0, no evidence of scaling; 1, minimal, occasional fine scale over less than 5% of the lesion; 2, mild, fine scales predominate; 3, moderate, coarse scales predominate; 4 marked, thick non-tenacious scale predominates; 5 severe, very thick tenacious scale predominates. | ITT Population | Posted | Number | participants | Baseline and Week 8 |
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| Primary | Number of Participants With an ISGA Score of Clear (0) or Almost Clear (1) for Scalp Involvement at Week 8 Using Last Observation Carried Forward (LOCF) | The investigator assessed participants with scalp psoriasis using the ISGA, scored as (as a visual average of lesions): 0, absence of disease; 1, very mild disease, lesions (L) with minimum erythema; 2, mild disease, L with light-red coloration, slight thickness, and fine, thin scale layer; 3, moderate disease, L with red coloration, moderate thickness, and a moderate scaled layer; 4, severe disease, L with red coloration, severe thickness, and a severe coarse, thick scale layer; 5, very severe disease, L with red coloration, very severe thickness, and a very severe, coarse, thick scale layer. | ITT Population. Missing values were imputed using LOCF (i.e., the last available observation, including Baseline, for a participant will be used to estimate subsequent missing data points). | Posted | Number | participants | Week 8 |
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| Secondary | Number of Participants With a Target Lesion Score of 0 or 1 for Plaque Thickness at Week 8 | Psoriasis is a noncontagious skin disorder, most often appearing as inflamed, thickened skin covered with silvery white scales on the scalp, trunk, and limbs. The investigator assessed participants with plaque thickness at target lesions using the PGSTL scores: 0, no elevation over normal skin; 1, possible but difficult to ascertain whether there is a slight elevation above normal skin; 2, slight but definite elevation, edges are indistinct or sloped; 3, moderate elevation with rough or sloped edges; 4, marked elevation with hard or sharp edges; 5, very marked elevation with hard sharp edges. | ITT Population | Posted | Number | participants | Baseline and Week 8 |
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| Secondary | Number of Participants With an ISGA Score of Clear (0) or Almost Clear (1) for Body Involvement at Week 8 | The investigator assessed participants with psoriasis with body involvement using the ISGA, scored as: 0, clear, minor residual discoloration, no erythema, scaling, or plaque thickness; 1, almost clear, occasional fine scale, faint erythema, and barely perceptible plaque thickness; 2, mild, fine scales predominate with light-red coloration and mild plaque thickness; 3, moderate, coarse scales predominate with moderate red coloration and plaque thickness; 4 severe, thick tenacious scale predominates with deep red coloration and severe plaque thickness. Scores are a visual average of lesions. | ITT Population. Data were analyzed using the failure and LOCF methods. | Posted | Number | participants | 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 0.005% was applied to the affected area(s) on the scalp and body BD for 8 weeks. | 1 | 181 | 25 | 181 | ||
| EG001 | Vehicle Foam | Vehicle foam was applied to the affected area(s) on the scalp and body BD for 8 weeks. | 3 | 182 | 17 | 182 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest discomfort | General disorders | MedDRA | Systematic Assessment |
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| Cholecystitis acute | Hepatobiliary disorders | MedDRA | Systematic Assessment |
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| Multiple fractures | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Alcohol abuse | Psychiatric disorders | MedDRA | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site pruritus | General disorders | MedDRA | Systematic Assessment |
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| Application site pain | General disorders | MedDRA | Systematic Assessment |
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| Application site erythema | General disorders | MedDRA | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Application site dermatitis | General disorders | MedDRA | Systematic Assessment |
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| Skin burning sensation | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA | 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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| Male |
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| Asian |
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| Black |
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| Multiracial |
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| Native Hawaiian/Other Pacific Islander |
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| White |
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| Missing |
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| Units |
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| Counts |
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