| Primary | Number of Participants With Improvement of at Least 2 Grades in the Investigator's Static Global Assessment (ISGA) (Target Hand) Score From Baseline to Day 15 | The investigator rated chronic hand dermatitis of the participants' target hand using the 5-point ISGA: 0=clear, minor residual discoloration, no erythema (redness of skin)/induration (skin hardening)/papulation (eruption of small, rounded solid bumps on skin), no oozing/crusting; 1=almost clear, trace faint pink erythema, no induration/papulation and no oozing/crusting; 2=mild, faint pink erythema, mild induration/papulation; 3=moderate, pink-red erythema, moderate induration/papulation, some oozing/crusting; 4=Severe, bright-red erythema, severe induration/papulation, oozing/crusting. | Intent-to-Treat (ITT) Population: all randomized participants who were dispensed study product. Missing values were imputed using last observation carried forward (LOCF, i.e., the last available observation, including Baseline, for a participant was used to estimate subsequent missing data points). | Posted | | Number | | participants | | Baseline (Day 1) and Day 15 | | | | ID | Title | Description |
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| OG000 | Olux-E Foam | Olux-E foam containing 0.05% clobestasol propionate, applied twice daily (morning and evening [BD]) for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 grams (g) per week | | OG001 | Vehicle Foam | Vehicle foam without the active ingredient clobestasol propionate, applied BD for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 g per week |
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | Cochran-Mantel-Haenszel | | 0.151 | Cochran-Mantel-Haenszel (CMH) test stratified by center was used for analysis. | | | | | | 95 | | | | | | | Superiority or Other | | |
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| Secondary | Number of Participants With an Improvement of at Least 1 Grade in the ISGA (Target Hand) Score From Baseline to Day 15 | The investigator rated chronic hand dermatitis of the participants' target hand using the 5-point ISGA: 0=clear, minor residual discoloration, no erythema (redness of skin)/induration (skin hardening)/papulation (eruption of small, rounded solid bumps on skin), no oozing/crusting; 1=almost clear, trace faint pink erythema, no induration/papulation and no oozing/crusting; 2=mild, faint pink erythema, mild induration/papulation; 3=moderate, pink-red erythema, moderate induration/papulation, some oozing/crusting; 4=Severe, bright-red erythema, severe induration/papulation, oozing/crusting. | ITT Population. Missing values were imputed using LOCF (i.e., the last available observation, including Baseline, for a participant was used to estimate subsequent missing data points). | Posted | | Number | | participants | | Baseline (Day 1) and Day 15 | | | | ID | Title | Description |
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| OG000 | Olux-E Foam | Olux-E foam containing 0.05% clobestasol propionate, applied twice daily (morning and evening [BD]) for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 grams (g) per week | | OG001 | Vehicle Foam | Vehicle foam without the active ingredient clobestasol propionate, applied BD for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 g per week |
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| Secondary | Number of Participants With an Improvement of at Least 2 Grades in the ISGA (Target Hand) Score From Baseline to Day 3 and to Day 8 | The investigator rated chronic hand dermatitis of the participants' target hand using the 5-point ISGA: 0=clear, minor residual discoloration, no erythema (redness of skin)/induration (skin hardening)/papulation (eruption of small, rounded solid bumps on skin), no oozing/crusting; 1=almost clear, trace faint pink erythema, no induration/papulation and no oozing/crusting; 2=mild, faint pink erythema, mild induration/papulation; 3=moderate, pink-red erythema, moderate induration/papulation, some oozing/crusting; 4=Severe, bright-red erythema, severe induration/papulation, oozing/crusting. | ITT Population. Missing values were imputed using LOCF (i.e., the last available observation, including Baseline, for a participant was used to estimate subsequent missing data points). | Posted | | Number | | participants | | Baseline (Day 1), Day 3, and Day 8 | | | | ID | Title | Description |
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| OG000 | Olux-E Foam | Olux-E foam containing 0.05% clobestasol propionate, applied twice daily (morning and evening [BD]) for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 grams (g) per week | | OG001 | Vehicle Foam | Vehicle foam without the active ingredient clobestasol propionate, applied BD for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 g per week |
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| Secondary | Number of Participants With an Improvement of at Least 1 Grade in the ISGA (Target Hand) Score From Baseline to Day 3 and and to Day 8 | The investigator rated chronic hand dermatitis of the participants' target hand using the 5-point ISGA: 0=clear, minor residual discoloration, no erythema (redness of skin)/induration (skin hardening)/papulation (eruption of small, rounded solid bumps on skin), no oozing/crusting; 1=almost clear, trace faint pink erythema, no induration/papulation and no oozing/crusting; 2=mild, faint pink erythema, mild induration/papulation; 3=moderate, pink-red erythema, moderate induration/papulation, some oozing/crusting; 4=Severe, bright-red erythema, severe induration/papulation, oozing/crusting. | ITT Population. Missing values were imputed using LOCF (i.e., the last available observation, including Baseline, for a participant was used to estimate subsequent missing data points). | Posted | | Number | | participants | | Baseline (Day 1), Day 3, and Day 8 | | | | ID | Title | Description |
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| OG000 | Olux-E Foam | Olux-E foam containing 0.05% clobestasol propionate, applied twice daily (morning and evening [BD]) for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 grams (g) per week | | OG001 | Vehicle Foam | Vehicle foam without the active ingredient clobestasol propionate, applied BD for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 g per week |
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| Secondary | Number of Participants With an ISGA (Target Hand) Score of 0 or 1 at Days 3, 8, and 15 | The investigator rated chronic hand dermatitis of the participants' target hand using the 5-point ISGA: 0=clear, minor residual discoloration, no erythema (redness of skin)/induration (skin hardening)/papulation (eruption of small, rounded solid bumps on skin), no oozing/crusting; 1=almost clear, trace faint pink erythema, no induration/papulation and no oozing/crusting; 2=mild, faint pink erythema, mild induration/papulation; 3=moderate, pink-red erythema, moderate induration/papulation, some oozing/crusting; 4=Severe, bright-red erythema, severe induration/papulation, oozing/crusting. | ITT Population. Missing values were imputed using LOCF (i.e., the last available observation, including Baseline, for a participant was used to estimate subsequent missing data points). | Posted | | Number | | participants | | Days 3, 8, and 15 | | | | ID | Title | Description |
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| OG000 | Olux-E Foam | Olux-E foam containing 0.05% clobestasol propionate, applied twice daily (morning and evening [BD]) for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 grams (g) per week | | OG001 | Vehicle Foam | Vehicle foam without the active ingredient clobestasol propionate, applied BD for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 g per week |
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| Secondary | Number of Participants With an Improvement of at Least 1 Grade in the Subject Global Assessment (SGA) (Target Hand) Score From Baseline to Days 3, 8, and 15 | On Days 1, 3, 8, and 15 prior to the investigator assessment, participants rated chronic hand dermatitis of the target hand using the 5-point SGA: 0=skin is clear; 1=dermatitis in minimal, there may be a few light-pink areas; 2=dermatitis is mild, there may be occasional light-pink areas; 3=dermatitis is moderate, there may be easily noticeable pink-red areas; 4=dermatitis is severe, there may be deep or bright-red areas that may be warm to the touch. | ITT Population. Missing values were imputed using LOCF (i.e., the last available observation, including Baseline, for a participant was used to estimate subsequent missing data points). | Posted | | Number | | participants | | Baseline (Day 1) and Days 3, 8, and 15 | | | | ID | Title | Description |
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| OG000 | Olux-E Foam | Olux-E foam containing 0.05% clobestasol propionate, applied twice daily (morning and evening [BD]) for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 grams (g) per week | | OG001 | Vehicle Foam | Vehicle foam without the active ingredient clobestasol propionate, applied BD for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 g per week |
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| Secondary | Number of Participants With an SGA (Target Hand) Score of 0 or 1 at Days 3, 8, and 15 | On Days 1, 3, 8, and 15 prior to the investigator assessment, participants rated chronic hand dermatitis of the target hand using the 5-point SGA: 0=skin is clear; 1=dermatitis in minimal, there may be a few light-pink areas; 2=dermatitis is mild, there may be occasional light-pink areas; 3=dermatitis is moderate, there may be easily noticeable pink-red areas; 4=dermatitis is severe, there may be deep or bright-red areas that may be warm to the touch. | ITT Population. Missing values were imputed using LOCF (i.e., the last available observation, including Baseline, for a participant was used to estimate subsequent missing data points). | Posted | | Number | | participants | | Days 3, 8, and 15 | | | | ID | Title | Description |
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| OG000 | Olux-E Foam | Olux-E foam containing 0.05% clobestasol propionate, applied twice daily (morning and evening [BD]) for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 grams (g) per week | | OG001 | Vehicle Foam | Vehicle foam without the active ingredient clobestasol propionate, applied BD for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 g per week |
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| Secondary | Percent Change From Baseline in Pruritus, Stinging, Burning, and Pain Scores (Target Hand) at Days 3, 8, and 15 | On Days 1, 3, 8, and 15, participants assessed the pruritis (itching), stinging (piercing pain), burning, and pain of the target hand. Participants were instructed to assess the level/severity of the indicated symptoms over the previous 24 hours using a scale ranging from 0 (none) to 10 (unbearable). Percent change from baseline was calculated as value at Days 3, 8, and 15 minus the value at Baseline divided by the Baseline value * 100. | ITT Population. Only those participants contributing data at the indicated time points were analyzed. | Posted | | Mean | Standard Deviation | Percent change in scores on a scale | | Baseline (Day 1) and Days 3, 8, and 15 | | | | ID | Title | Description |
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| OG000 | Olux-E Foam | Olux-E foam containing 0.05% clobestasol propionate, applied twice daily (morning and evening [BD]) for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 grams (g) per week | | OG001 | Vehicle Foam | Vehicle foam without the active ingredient clobestasol propionate, applied BD for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 g per week |
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