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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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The purpose of the study is to compare the efficacy and safety of Clobetasol propionate to that of its Vehicle in the treatment of mild to moderate plaque-type psoriasis.
The purpose of the study is to compare the efficacy and safety of Clobetasol propionate to that of its Vehicle in the treatment of mild to moderate plaque-type psoriasis. This is a multi-center, double blind, randomized, parallel designed study which consists of 2 weeks of treatment and a follow-up visit 2 weeks later.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clobetasol Propionate Foam | Experimental | Topical foam formulation that includes clobetasol propionate (Steroid) |
|
| Vehicle Foam | Placebo Comparator | Vehicle foam is the same as the clobetasol propionate foam except it does not include the active drug. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clobetasol propionate foam | Drug | Topical Clobetasol propionate foam |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Target Lesion Global Improvement (TLGI) Score of 0, 1, or 2 at Weeks 1, 2, and 4 | The investigator assessed the TLGI of participants relative to their initial Baseline condition based on a 7-point scale: 0=completely cleared, possible residual discoloration; 1=almost cleared, 90% improvement, very significant clearance with only traces of disease remaining; 2=marked improvement, approximately 75%, with some disease remaining; 3=moderate improvement, approximately 50%; 4=mild improvement, approximately 25%, significant disease remains; 5=no change, no detectable improvement; 6=excerbation, worsening of signs and symptoms of disease. | Weeks 1, 2, and 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a TLGI Score of 0, 1, 2, or 3 at Weeks 1, 2, and 4 | The investigator assessed the TLGI of participants relative to their initial Baseline condition based on a 7-point scale: 0=completely cleared, possible residual discoloration; 1=almost cleared, 90% improvement, very significant clearance with only traces of disease remaining; 2=marked improvement, approximately 75%, with some disease remaining; 3=moderate improvement, approximately 50%; 4=mild improvement, approximately 25%, significant disease remains; 5=no change, no detectable improvement; 6=excerbation, worsening of signs and symptoms of disease. |
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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 |
|---|---|---|---|---|---|---|
| Center for Dermatology, Cosmetic and Laser | Fremont | California | 94538 | United States | ||
| Dermatology Specialists |
A wash-out period of 2 to 8 weeks, the duration of which varied by specific medication, was required prior to Visit 1.
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| ID | Title | Description |
|---|---|---|
| FG000 | Olux-E Foam | Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body |
| FG001 | Vehicle Foam | Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Olux-E Foam | Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body |
| BG001 | Vehicle Foam |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 a Target Lesion Global Improvement (TLGI) Score of 0, 1, or 2 at Weeks 1, 2, and 4 | The investigator assessed the TLGI of participants relative to their initial Baseline condition based on a 7-point scale: 0=completely cleared, possible residual discoloration; 1=almost cleared, 90% improvement, very significant clearance with only traces of disease remaining; 2=marked improvement, approximately 75%, with some disease remaining; 3=moderate improvement, approximately 50%; 4=mild improvement, approximately 25%, significant disease remains; 5=no change, no detectable improvement; 6=excerbation, worsening of signs and symptoms of disease. | Intent-to-Treat (ITT) Population: all enrolled participants. Participants who returned for the visit specified (Week 1, 2, and/or 4) were evaluated; not all participants returned for every study visit. | Posted | Number | participants | Weeks 1, 2, and 4 |
|
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One participant in the ITT Population was dispensed study drug but did not return after the Baseline visit; thus, this participant was not included in the analysis of serious adverse events (SAEs) or non-serious AEs.
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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 | Olux-E Foam | Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tooth Extraction Surgery | General disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D002990 | Clobetasol |
| ID | Term |
|---|---|
| D001623 | Betamethasone |
| D013259 | Steroids, Fluorinated |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Vehicle foam | Drug | Vehicle foam does not include the active drug. |
|
| Weeks 1, 2, and 4 |
| Number of Participants With a Pruritus (Overall) Score of 0 or 1 at Week 2 | Participants assessed their level of pruritus (itching) over the previous 24-hour period using the following scale: 0=no itching; 1=minimal, very rarely aware of localized itching, present when relaxing and lasted for very short time; 2=mild, aware of itching at times, present when relaxing, not present when focused on other activities; 3=moderate, often aware of itching, annoying, sometimes disturbed sleep and daytime activities; and 4=severe, constant itching, distressing, frequent sleep disturbance, interfered with activities. | Week 2 |
| Number of Participants With an Erythema Score of 0 or 1 at Week 2 | The investigator individually graded the severity of erythema (redness of skin) in participants as: 0=hyperpigmentation, pigmented macules (flat, distinct, colored area of skin), diffuse faint pink or red coloration; 1=no evidence of erythema, hyperpigmentation present; 2=faint erythema; 3=light red coloration; 4=moderate red coloration; and 5=bright red coloration. | Week 2 |
| Number of Participants With a Scaling Score of 0 or 1 at Week 2 | The investigator individually graded the severity of scaling in participants as: 0=no scaling; 1=no evidence of scaling; 2=minimal, occasional fine scale over less than 5% of the lesion; 3=mild, fine scales predominate; 4=moderate, coarse scales predominate; and 5=marked, thick nontenacious scales predominate. | Week 2 |
| Number of Participants With a Plaque Thickness Score of 0 or 1 at Week 2 | The investigator individually graded the severity of plaque thickness in participants as: 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, typically edges are indistinct or sloped; 3=moderate elevation with rough or sloped edges; 4=marked elevation typically with hard or sharp edges; and 5=very marked elevation typically with hard, sharp edges. | Week 2 |
| Number of Participants With a Score of 0 or 1 for Subject Global Assessment at Week 2 | Participants assessed all treated areas using the Subject Global Assessment scale: 0=skin completely clear, possible residual hyperpigmentation; 1=psoriasis almost clear, patchy remnants of fine scaling present; 2=psoriasis mild, with small amount of psoriasis remaining (i.e., fine to coarse scales in some areas, definite redness, barely visible plaque thickness); 3=psoriasis moderate, between slight and definitely noticeable; 4=psoriasis very noticeable with redness, scaling, plaque thickness; 5=psoriasis severe with severe redness, thick scaling, and plaques. | Week 2 |
| Mean Percent Change From Baseline to Week 2 in Pruritus (Target Lesion) | Participants assessed their level of pruritus (itching) for the target lesion using a 10 centimeter (cm) Visual Analogue Scale (VAS) with the left side anchored with "0=None" and the right side anchored with "10=Very Severe." A target lesion (>2 cm squared [cm^2]) was considered to be one on the trunk or extremities (excluding palms/soles, elbows, or knees). Percent change from Baseline was calculated as the value at Week 2 minus the value at Baseline (Week 0) divided by the Baseline (Week 0) value * 100. | Baseline (Week 0) and Week 2 |
| Mean Percent Change From Baseline to Week 2 in Percent (%) of Body Surface Area (BSA) Affected | Percent change from Baseline was calculated as the value at Week 2 minus the value at Baseline (Week 0) divided by the Baseline (Week 0) value * 100. Data for this outcome measure were not collected; thus, no data were analyzed. | Baseline (Week 0) and Week 2 |
| Number of Participants With a TLGI Score of 0, 1, or 2 at Week 1 and Week 4 | The investigator assessed the TLGI of participants relative to their initial Baseline condition based on a 7-point scale: 0=completely cleared, possible residual discoloration; 1=almost cleared, 90% improvement, very significant clearance with only traces of disease remaining; 2=marked improvement, approximately 75%, with some disease remaining; 3=moderate improvement, approximately 50%; 4=mild improvement, approximately 25%, significant disease remains; 5=no change, no detectable improvement; 6=excerbation, worsening of signs and symptoms of disease. | Week 1 and Week 4 |
| Number of Participants With a Pruritus (Overall) Score of 0 or 1 at Baseline and Week 4 | Participants assessed their level of pruritus (itching) over the previous 24-hour period using the following scale: 0=no itching; 1=minimal, very rarely aware of localized itching, present when relaxing and lasted for very short time; 2=mild, aware of itching at times, present when relaxing, not present when focused on other activities; 3=moderate, often aware of itching, annoying, sometimes disturbed sleep and daytime activities; and 4=severe, constant itching, distressing, frequent sleep disturbance, interfered with activities. | Baseline (Week 0) and Week 4 |
| Number of Participants With an Erythema Score of 0 or 1 at Baseline and Week 4 | The investigator individually graded the severity of erythema (redness of skin) in participants as: 0=hyperpigmentation, pigmented macules (flat, distinct, colored area of skin), diffuse faint pink or red coloration; 1=no evidence of erythema, hyperpigmentation present; 2=faint erythema; 3=light red coloration; 4=moderate red coloration; and 5=bright red coloration. | Baseline (Week 0) and Week 4 |
| Number of Participants With a Scaling Score of 0 or 1 at Baseline and Week 4 | The investigator individually graded the severity of scaling in participants as: 0=no scaling; 1=no evidence of scaling; 2=minimal, occasional fine scale over less than 5% of the lesion; 3=mild, fine scales predominate; 4=moderate, coarse scales predominate; and 5=marked, thick nontenacious scales predominate. | Baseline (Week 0) and Week 4 |
| Number of Participants With a Plaque Thickness Score of 0 or 1 at Baseline and Week 4 | The investigator individually graded the severity of plaque thickness in participants as: 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, typically edges are indistinct or sloped; 3=moderate elevation with rough or sloped edges; 4=marked elevation typically with hard or sharp edges; and 5=very marked elevation typically with hard, sharp edges. | Baseline (Week 0) and Week 4 |
| Number of Participants With a Score of 0 or 1 for Subject Global Assessment at Baseline and Week 4 | Participants assessed all treated areas using the Subject Global Assessment scale: 0=skin completely clear, possible residual hyperpigmentation; 1=psoriasis almost clear, patchy remnants of fine scaling present; 2=psoriasis mild, with small amount of psoriasis remaining (i.e., fine to coarse scales in some areas, definite redness, barely visible plaque thickness); 3=psoriasis moderate, between slight and definitely noticeable; 4=psoriasis very noticeable with redness, scaling, plaque thickness; 5=psoriasis severe with severe redness, thick scaling, and plaques. | Baseline (Week 0) and Week 4 |
| Mean Percent Change From Baseline to Week 4 in Pruritus (Target Lesion) | Participants assessed their level of pruritus (itching) for the target lesion using a 10 centimeter (cm) Visual Analogue Scale (VAS) with the left side anchored with "0=None" and the right side anchored with "10=Very Severe." A target lesion (>2 cm squared [cm^2]) was considered to be one on the trunk or extremities (excluding palms/soles, elbows, or knees). Percent change from Baseline was calculated as the value at Week 4 minus the value at Baseline (Week 0) divided by the Baseline (Week 0) value * 100. | Baseline (Week 0) and Week 4 |
| Mean Percent Change From Baseline to Week 4 in Percent (%) of Body Surface Area (BSA) Affected | Percent change from Baseline was calculated as the value at Week 4 minus the value at Baseline (Week 0) divided by the Baseline (Week 0) value * 100. Data for this outcome measure were not collected; thus, no data were analyzed. | Baseline (Week 0) and Week 4 |
| Louisville |
| Kentucky |
| 40202 |
| United States |
Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body |
| OG001 | Vehicle Foam | Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body |
|
|
|
| Secondary | Number of Participants With a TLGI Score of 0, 1, 2, or 3 at Weeks 1, 2, and 4 | The investigator assessed the TLGI of participants relative to their initial Baseline condition based on a 7-point scale: 0=completely cleared, possible residual discoloration; 1=almost cleared, 90% improvement, very significant clearance with only traces of disease remaining; 2=marked improvement, approximately 75%, with some disease remaining; 3=moderate improvement, approximately 50%; 4=mild improvement, approximately 25%, significant disease remains; 5=no change, no detectable improvement; 6=excerbation, worsening of signs and symptoms of disease. | ITT Population. Participants who returned for the visit specified (Week 1, 2, and/or 4) were evaluated; not all participants returned for every study visit. | Posted | Number | participants | Weeks 1, 2, and 4 |
|
|
|
| Secondary | Number of Participants With a Pruritus (Overall) Score of 0 or 1 at Week 2 | Participants assessed their level of pruritus (itching) over the previous 24-hour period using the following scale: 0=no itching; 1=minimal, very rarely aware of localized itching, present when relaxing and lasted for very short time; 2=mild, aware of itching at times, present when relaxing, not present when focused on other activities; 3=moderate, often aware of itching, annoying, sometimes disturbed sleep and daytime activities; and 4=severe, constant itching, distressing, frequent sleep disturbance, interfered with activities. | ITT Population. Participants who returned for the visit specified (Week 2) were evaluated; not all participants returned for every study visit. | Posted | Number | participants | Week 2 |
|
|
|
| Secondary | Number of Participants With an Erythema Score of 0 or 1 at Week 2 | The investigator individually graded the severity of erythema (redness of skin) in participants as: 0=hyperpigmentation, pigmented macules (flat, distinct, colored area of skin), diffuse faint pink or red coloration; 1=no evidence of erythema, hyperpigmentation present; 2=faint erythema; 3=light red coloration; 4=moderate red coloration; and 5=bright red coloration. | ITT Population. Participants who returned for the visit specified (Week 2) were evaluated; not all participants returned for every study visit. | Posted | Number | participants | Week 2 |
|
|
|
| Secondary | Number of Participants With a Scaling Score of 0 or 1 at Week 2 | The investigator individually graded the severity of scaling in participants as: 0=no scaling; 1=no evidence of scaling; 2=minimal, occasional fine scale over less than 5% of the lesion; 3=mild, fine scales predominate; 4=moderate, coarse scales predominate; and 5=marked, thick nontenacious scales predominate. | ITT Population. Participants who returned for the visit specified (Week 2) were evaluated; not all participants returned for every study visit. | Posted | Number | participants | Week 2 |
|
|
|
| Secondary | Number of Participants With a Plaque Thickness Score of 0 or 1 at Week 2 | The investigator individually graded the severity of plaque thickness in participants as: 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, typically edges are indistinct or sloped; 3=moderate elevation with rough or sloped edges; 4=marked elevation typically with hard or sharp edges; and 5=very marked elevation typically with hard, sharp edges. | ITT Population. Participants who returned for the visit specified (Week 2) were evaluated; not all participants returned for every study visit. | Posted | Number | participants | Week 2 |
|
|
|
| Secondary | Number of Participants With a Score of 0 or 1 for Subject Global Assessment at Week 2 | Participants assessed all treated areas using the Subject Global Assessment scale: 0=skin completely clear, possible residual hyperpigmentation; 1=psoriasis almost clear, patchy remnants of fine scaling present; 2=psoriasis mild, with small amount of psoriasis remaining (i.e., fine to coarse scales in some areas, definite redness, barely visible plaque thickness); 3=psoriasis moderate, between slight and definitely noticeable; 4=psoriasis very noticeable with redness, scaling, plaque thickness; 5=psoriasis severe with severe redness, thick scaling, and plaques. | ITT Population. Participants who returned for the visit specified (Week 2) were evaluated; not all participants returned for every study visit. | Posted | Number | participants | Week 2 |
|
|
|
| Secondary | Mean Percent Change From Baseline to Week 2 in Pruritus (Target Lesion) | Participants assessed their level of pruritus (itching) for the target lesion using a 10 centimeter (cm) Visual Analogue Scale (VAS) with the left side anchored with "0=None" and the right side anchored with "10=Very Severe." A target lesion (>2 cm squared [cm^2]) was considered to be one on the trunk or extremities (excluding palms/soles, elbows, or knees). Percent change from Baseline was calculated as the value at Week 2 minus the value at Baseline (Week 0) divided by the Baseline (Week 0) value * 100. | ITT Population. Participants who returned for the visit specified (Week 2) and/or provided an assessment of pruritis were evaluated; not all participants returned for every study visit. | Posted | Mean | Standard Deviation | Percent change in scores on a scale | Baseline (Week 0) and Week 2 |
|
|
|
| Secondary | Mean Percent Change From Baseline to Week 2 in Percent (%) of Body Surface Area (BSA) Affected | Percent change from Baseline was calculated as the value at Week 2 minus the value at Baseline (Week 0) divided by the Baseline (Week 0) value * 100. Data for this outcome measure were not collected; thus, no data were analyzed. | ITT Population | Posted | Baseline (Week 0) and Week 2 |
|
|
| Secondary | Number of Participants With a TLGI Score of 0, 1, or 2 at Week 1 and Week 4 | The investigator assessed the TLGI of participants relative to their initial Baseline condition based on a 7-point scale: 0=completely cleared, possible residual discoloration; 1=almost cleared, 90% improvement, very significant clearance with only traces of disease remaining; 2=marked improvement, approximately 75%, with some disease remaining; 3=moderate improvement, approximately 50%; 4=mild improvement, approximately 25%, significant disease remains; 5=no change, no detectable improvement; 6=excerbation, worsening of signs and symptoms of disease. | ITT Population. Participants who returned for the visit specified (Week 1 and/or 4) and/or provided an assessment for pruritus were evaluated; not all participants returned for every study visit. | Posted | Number | participants | Week 1 and Week 4 |
|
|
|
| Secondary | Number of Participants With a Pruritus (Overall) Score of 0 or 1 at Baseline and Week 4 | Participants assessed their level of pruritus (itching) over the previous 24-hour period using the following scale: 0=no itching; 1=minimal, very rarely aware of localized itching, present when relaxing and lasted for very short time; 2=mild, aware of itching at times, present when relaxing, not present when focused on other activities; 3=moderate, often aware of itching, annoying, sometimes disturbed sleep and daytime activities; and 4=severe, constant itching, distressing, frequent sleep disturbance, interfered with activities. | ITT Population Participants who returned for the visit specified (Week 4) and/or provided an assessment for pruritus were evaluated; not all participants returned for every study visit. | Posted | Number | participants | Baseline (Week 0) and Week 4 |
|
|
|
| Secondary | Number of Participants With an Erythema Score of 0 or 1 at Baseline and Week 4 | The investigator individually graded the severity of erythema (redness of skin) in participants as: 0=hyperpigmentation, pigmented macules (flat, distinct, colored area of skin), diffuse faint pink or red coloration; 1=no evidence of erythema, hyperpigmentation present; 2=faint erythema; 3=light red coloration; 4=moderate red coloration; and 5=bright red coloration. | ITT Population. Participants who returned for the visit specified (Week 4) and/or provided an assessment for erythema were evaluated; not all participants returned for every study visit. | Posted | Number | participants | Baseline (Week 0) and Week 4 |
|
|
|
| Secondary | Number of Participants With a Scaling Score of 0 or 1 at Baseline and Week 4 | The investigator individually graded the severity of scaling in participants as: 0=no scaling; 1=no evidence of scaling; 2=minimal, occasional fine scale over less than 5% of the lesion; 3=mild, fine scales predominate; 4=moderate, coarse scales predominate; and 5=marked, thick nontenacious scales predominate. | ITT Population. Participants who returned for the visit specified (Week 4) and/or provided an assessment for scaling were evaluated; not all participants returned for every study visit. | Posted | Number | participants | Baseline (Week 0) and Week 4 |
|
|
|
| Secondary | Number of Participants With a Plaque Thickness Score of 0 or 1 at Baseline and Week 4 | The investigator individually graded the severity of plaque thickness in participants as: 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, typically edges are indistinct or sloped; 3=moderate elevation with rough or sloped edges; 4=marked elevation typically with hard or sharp edges; and 5=very marked elevation typically with hard, sharp edges. | ITT Population. Participants who returned for the visit specified (Week 4) and/or provided an assessment for plaque thickness were evaluated; not all participants returned for every study visit. | Posted | Number | participants | Baseline (Week 0) and Week 4 |
|
|
|
| Secondary | Number of Participants With a Score of 0 or 1 for Subject Global Assessment at Baseline and Week 4 | Participants assessed all treated areas using the Subject Global Assessment scale: 0=skin completely clear, possible residual hyperpigmentation; 1=psoriasis almost clear, patchy remnants of fine scaling present; 2=psoriasis mild, with small amount of psoriasis remaining (i.e., fine to coarse scales in some areas, definite redness, barely visible plaque thickness); 3=psoriasis moderate, between slight and definitely noticeable; 4=psoriasis very noticeable with redness, scaling, plaque thickness; 5=psoriasis severe with severe redness, thick scaling, and plaques. | ITT Population. Participants who returned for the visit specified (Week 4) and/or provided an assessment for Subject Global Assessment were evaluated; not all participants returned for every study visit. | Posted | Number | participants | Baseline (Week 0) and Week 4 |
|
|
|
| Secondary | Mean Percent Change From Baseline to Week 4 in Pruritus (Target Lesion) | Participants assessed their level of pruritus (itching) for the target lesion using a 10 centimeter (cm) Visual Analogue Scale (VAS) with the left side anchored with "0=None" and the right side anchored with "10=Very Severe." A target lesion (>2 cm squared [cm^2]) was considered to be one on the trunk or extremities (excluding palms/soles, elbows, or knees). Percent change from Baseline was calculated as the value at Week 4 minus the value at Baseline (Week 0) divided by the Baseline (Week 0) value * 100. | ITT Population. Participants who returned for the visit specified (Week 4) and/or provided an assessment for pruritus were evaluated; not all participants returned for every study visit. | Posted | Mean | Standard Deviation | Percent change in scores on a scale | Baseline (Week 0) and Week 4 |
|
|
|
| Secondary | Mean Percent Change From Baseline to Week 4 in Percent (%) of Body Surface Area (BSA) Affected | Percent change from Baseline was calculated as the value at Week 4 minus the value at Baseline (Week 0) divided by the Baseline (Week 0) value * 100. Data for this outcome measure were not collected; thus, no data were analyzed. | ITT Population | Posted | Baseline (Week 0) and Week 4 |
|
|
| 0 |
| 27 |
| 3 |
| 27 |
| EG001 | Vehicle Foam | Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body | 0 | 30 | 6 | 30 |
| Common Cold | Infections and infestations | MedDRA | Systematic Assessment |
|
| Hemorrhoids | General disorders | MedDRA | Systematic Assessment |
|
| Sinusitis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Diagnosed Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Moderately Elevated Prostate-Specific Antigen (PSA) | General disorders | MedDRA | Systematic Assessment |
|
| Worsening Of Psoriasis, Upper Extremities | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Gastrointestinal Virus | Infections and infestations | MedDRA | Systematic Assessment |
|
| Papular Dermatitis On Left Upper Abdomen | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Left Shin, Target Area Worse, Severe Itching/Oozing/Wheeping | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
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.
| D011083 |
| Polycyclic Compounds |
| Week 4, n=27, 28 |
|