| Primary | Achievement of Scalp Investigator Global Assessment (S-IGA) "Success" at Week 8 | The percentage of participants with S-IGA success at Week 8 is presented. Success is defined as an IGA score of 'clear' or 'almost clear' plus a 2-point improvement from baseline at Week 8. This global assessment scale has five severity grades reported from 0-4 and defined as Clear (0), Almost Clear (1), Mild (2), Moderate (3), Severe (4), with higher scores indicative of greater symptom severity. | All randomized participants are included, with multiple imputation of missing data. | Posted | | Number | 97.5% Confidence Interval | percentage of participants | | Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Roflumilast Foam 0.3% | Participants with plaque psoriasis of the scalp and body applied roflumilast foam 0.3% qd for 8 weeks. | | OG001 | Vehicle Foam | Participants with plaque psoriasis of the scalp and body applied vehicle foam qd for 8 weeks. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
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| - OG00066.4(59.62 to 72.56)
- OG00127.8(20.12 to 37.10)
|
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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 |
|---|
| | Cochran-Mantel-Haenszel | Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data | <0.0001 | | Odds Ratio, log | 5.19 | | | 2-Sided | 97.5 | 2.90 | 9.31 | | | Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data | | Superiority | | |
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| Primary | Achievement of Body Investigator Global Assessment (B-IGA) Success at Week 8 | The percentage of participants with B-IGA success at Week 8 is presented. Success is defined as an IGA score of 'clear' or 'almost clear' plus a 2-point improvement from baseline at Week 8. This global assessment scale has five severity grades reported from 0-4 and defined as Clear (0), Almost Clear (1), Mild (2),Moderate (3), Severe (4), with higher scores indicative of greater symptom severity. | All randomized participants are included, with multiple imputation of missing data. | Posted | | Number | 97.5% Confidence Interval | percentage of participants | | Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Roflumilast Foam 0.3% | Participants with plaque psoriasis of the scalp and body applied roflumilast foam 0.3% qd for 8 weeks. | | OG001 | Vehicle Foam | Participants with plaque psoriasis of the scalp and body applied vehicle foam qd for 8 weeks. |
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| Secondary | Achievement of Scalp Itch-Numeric Rating Score (SI-NRS ) Success at Week 2 | The percentage of participants with SI-NRS success at Week 2 is presented. Success is defined as a ≥ 4-point improvement from baseline weekly in weekly average SI-NRS in participants with weekly average baseline SI-NRS score ≥4. SI-NRS is a subject-reported severity of itch at its highest intensity during the previous 24-hour period. The scale ranges from 0 ("no itch") to 10 ("worst imaginable itch"), with higher scores indicative of greater symptom severity. | All randomized participants with weekly average baseline SI-NRS ≥4 are included. | Posted | | Number | 97.5% Confidence Interval | percentage of participants | | Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Roflumilast Foam 0.3% | Participants with plaque psoriasis of the scalp and body applied roflumilast foam 0.3% qd for 8 weeks. | | OG001 | Vehicle Foam | Participants with plaque psoriasis of the scalp and body applied vehicle foam qd for 8 weeks. |
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| Secondary | Achievement of SI-NRS Success at Week 4 | The percentage of participants with SI-NRS success at Week 4 is presented. Success is defined as a ≥ 4-point improvement from baseline weekly in weekly average SI-NRS in participants with weekly average baseline SI-NRS score ≥4. SI-NRS is a subject-reported severity of itch at its highest intensity during the previous 24-hour period. The scale ranges from 0 ("no itch") to 10 ("worst imaginable itch"), with higher scores indicative of greater symptom severity. | All randomized participants with weekly average baseline SI-NRS ≥4 are included. | Posted | | Number | 97.5% Confidence Interval | percentage of participants | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Roflumilast Foam 0.3% | Participants with plaque psoriasis of the scalp and body applied roflumilast foam 0.3% qd for 8 weeks. | | OG001 | Vehicle Foam | Participants with plaque psoriasis of the scalp and body applied vehicle foam qd for 8 weeks. |
| |
| Secondary | Achievement of SI-NRS Success at Week 8 | The percentage of participants with SI-NRS success at Week 8 is presented. Success is defined as a ≥ 4-point improvement from baseline weekly in weekly average SI-NRS in participants with weekly average baseline SI-NRS score ≥4. SI-NRS is a subject-reported severity of itch at its highest intensity during the previous 24-hour period. The scale ranges from 0 ("no itch") to 10 ("worst imaginable itch"), with higher scores indicative of greater symptom severity. | All randomized participants with weekly average baseline SI-NRS ≥4 are included. | Posted | | Number | 97.5% Confidence Interval | percentage of participants | | Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Roflumilast Foam 0.3% | Participants with plaque psoriasis of the scalp and body applied roflumilast foam 0.3% qd for 8 weeks. | | OG001 | Vehicle Foam | Participants with plaque psoriasis of the scalp and body applied vehicle foam qd for 8 weeks. |
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| Secondary | Change From Baseline in SI-NRS Score at Day 1 | SI-NRS is a subject-reported severity of itch at its highest intensity during the previous 24-hour period. The scale ranges from 0 ("no itch") to 10 ("worst imaginable itch"), with higher scores indicative of greater symptom severity. A negative change from baseline indicates symptom improvement, and vice versa. | All randomized participants with average, weekly SI-NRS ≥4 at baseline are included. | Posted | | Least Squares Mean | Standard Error | score on a scale | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Roflumilast Foam 0.3% | Participants with plaque psoriasis of the scalp and body applied roflumilast foam 0.3% qd for 8 weeks. | | OG001 | Vehicle Foam | Participants with plaque psoriasis of the scalp and body applied vehicle foam qd for 8 weeks. |
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| Secondary | Change From Baseline in SI-NRS Score at Day 3 | SI-NRS is a subject-reported severity of itch at its highest intensity during the previous 24-hour period. The scale ranges from 0 ("no itch") to 10 ("worst imaginable itch"), with higher scores indicative of greater symptom severity. A negative change from baseline indicates symptom improvement, and vice versa. | All randomized participants are included. | Posted | | Least Squares Mean | Standard Error | score on a scale | | Day 3 | | | | ID | Title | Description |
|---|
| OG000 | Roflumilast Foam 0.3% | Participants with plaque psoriasis of the scalp and body applied roflumilast foam 0.3% qd for 8 weeks. | | OG001 | Vehicle Foam | Participants with plaque psoriasis of the scalp and body applied vehicle foam qd for 8 weeks. |
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| Secondary | Change From Baseline in SI-NRS Score at Week 1 | SI-NRS is a subject-reported severity of itch at its highest intensity during the previous 24-hour period. The scale ranges from 0 ("no itch") to 10 ("worst imaginable itch"), with higher scores indicative of greater symptom severity. A negative change from baseline indicates symptom improvement, and vice versa. | All randomized participants are included. | Posted | | Least Squares Mean | Standard Error | score on a scale | | Week 1 | | | | ID | Title | Description |
|---|
| OG000 | Roflumilast Foam 0.3% | Participants with plaque psoriasis of the scalp and body applied roflumilast foam 0.3% qd for 8 weeks. | | OG001 | Vehicle Foam | Participants with plaque psoriasis of the scalp and body applied vehicle foam qd for 8 weeks. |
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| Secondary | Achievement of WI-NRS (Worst Itch-Numeric Rating Score) Success at Week 8 | WI-NRS is a subject-reported severity of itch at its highest intensity during the previous 24-hour period. The scale is from 0 ("no itch") to 10 ("worst imaginable itch"). Success is defined as achievement of a ≥ 4-point improvement from baseline in participants with a baseline WI-NRS pruritus score of ≥ 4. | All randomized participants with average, weekly WI-NRS ≥4 at baseline are included. | Posted | | Number | 97.5% Confidence Interval | percentage of participants | | Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Roflumilast Foam 0.3% | Participants with plaque psoriasis of the scalp and body applied roflumilast foam 0.3% qd for 8 weeks. | | OG001 | Vehicle Foam | Participants with plaque psoriasis of the scalp and body applied vehicle foam qd for 8 weeks. |
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| Secondary | Achievement of a 75% Reduction From Baseline in Psoriasis Area and Severity Index (PASI-75) | The Psoriasis Area and Severity Index (PASI) is widely used for the measurement of severity of psoriasis. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range from 0 (no disease) to 72 (maximal disease), with higher scores indicating greater symptom severity. A decrease from baseline indicates symptom improvement, and vice versa. | All randomized participants are included, with multitple imputation of missing data. | Posted | | Number | 97.5% Confidence Interval | percentage of participants | | Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Roflumilast Foam 0.3% | Participants with plaque psoriasis of the scalp and body applied roflumilast foam 0.3% qd for 8 weeks. | | OG001 | Vehicle Foam | Participants with plaque psoriasis of the scalp and body applied vehicle foam qd for 8 weeks. |
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| Secondary | Change From Baseline in Psoriasis Symptoms Diary (PSD) Aggregate Score of Itching, Pain, and Scaling (Questions 1, 9, and 11) | The PSD is a 16-item questionnaire asking subjects to rate the severity of psoriasis-related symptoms in the past 24 hours. Each question is scored from 0 ("no symptoms") to 10 ("worst imaginable symptoms"). Scores range from 0 to 160, with higher scores indicating greater symptom severity. The aggregate Itching, Pain, and Scaling score ranges from 0 to 30; the change from baseline in aggregate score was assessed per protocol only in adult participants. | All randomized participants ≥18 years of age are included. | Posted | | Least Squares Mean | Standard Error | score on a scale | | Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Roflumilast Foam 0.3% | Participants with plaque psoriasis of the scalp and body applied roflumilast foam 0.3% qd for 8 weeks. | | OG001 | Vehicle Foam | Participants with plaque psoriasis of the scalp and body applied vehicle foam qd for 8 weeks. |
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| Secondary | Percentage of Participants Achieving PSD Itching (Question 1) Score of 0 at Week 8 | The PSD is a 16-item questionnaire asking subjects to rate the severity of psoriasis-related symptoms in the past 24 hours. Each question is scored from 0 ("no symptoms") to 10 ("worst imaginable symptoms"). Scores range from 0 to 160, with higher scores indicating greater symptom severity. The Scaling score ranges from 0 to 10. | All randomized participants ≥18 years of age are included. | Posted | | Number | 97.5% Confidence Interval | percentage of participants | | Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Roflumilast Foam 0.3% | Participants with plaque psoriasis of the scalp and body applied roflumilast foam 0.3% qd for 8 weeks. | | OG001 | Vehicle Foam | Participants with plaque psoriasis of the scalp and body applied vehicle foam qd for 8 weeks. |
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| Secondary | Percentage of Participants Achieving PSD Pain (Question 9) Score of 0 at Week 8 | The PSD is a 16-item questionnaire asking subjects to rate the severity of psoriasis-related symptoms in the past 24 hours. Each question is scored from 0 ("no symptoms") to 10 ("worst imaginable symptoms"). Scores range from 0 to 160, with higher scores indicating greater symptom severity. The Pain score ranges from 0 to 10. | All randomized participants ≥18 years of age are included. | Posted | | Number | 97.5% Confidence Interval | percentage of participants | | Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Roflumilast Foam 0.3% | Participants with plaque psoriasis of the scalp and body applied roflumilast foam 0.3% qd for 8 weeks. | | OG001 | Vehicle Foam | Participants with plaque psoriasis of the scalp and body applied vehicle foam qd for 8 weeks. |
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| Secondary | Percentage of Participants Achieving PSD Scaling (Question 11) Score of 0 at Week 8 | The PSD is a 16-item questionnaire asking subjects to rate the severity of psoriasis-related symptoms in the past 24 hours. Each question is scored from 0 ("no symptoms") to 10 ("worst imaginable symptoms"). Scores range from 0 to 160, with higher scores indicating greater symptom severity. The Scaling score ranges from 0 to 10. | All randomized participants ≥18 years of age are included. | Posted | | Number | 97.5% Confidence Interval | percentage of participants | | Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Roflumilast Foam 0.3% | Participants with plaque psoriasis of the scalp and body applied roflumilast foam 0.3% qd for 8 weeks. | | OG001 | Vehicle Foam | Participants with plaque psoriasis of the scalp and body applied vehicle foam qd for 8 weeks. |
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| Secondary | Percentage of Participants Achieving PSD Total Score of 0 at Week 8 | | All randomized participants ≥18 years of age are included. | Posted | | Number | 97.5% Confidence Interval | percentage of participants | | Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Roflumilast Foam 0.3% | Participants with plaque psoriasis of the scalp and body applied roflumilast foam 0.3% qd for 8 weeks. | | OG001 | Vehicle Foam | Participants with plaque psoriasis of the scalp and body applied vehicle foam qd for 8 weeks. |
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| Secondary | Achievement of a 75% Reduction From Baseline in Psoriasis Scalp Severity Index (PSSI) Score (PSSI-75) | The PSSI combines the assessment of the severity of scalp lesions and the area of scalp affected into a single score in the range 0 (no disease) to 72 (maximal disease). PSSI combines the assessment of the severity of scalp lesions and the area of scalp affected into a single score in the range 0 (no disease) to 72 (maximal disease). | All randomized participants are included, with multiple imputation of missing data.. | Posted | | Number | 97.5% Confidence Interval | percentage of participants | | Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Roflumilast Foam 0.3% | Participants with plaque psoriasis of the scalp and body applied roflumilast foam 0.3% qd for 8 weeks. | | OG001 | Vehicle Foam | Participants with plaque psoriasis of the scalp and body applied vehicle foam qd for 8 weeks. |
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| Secondary | Achievement of S-IGA Score of 'Clear' at Week 8 | The percentage of participants with S-IGA score of 0 Week 8 is presented. This global assessment scale has five severity grades reported from 0-4 and defined as Clear (0), Almost Clear (1), Mild (2), Moderate (3), Severe (4), with higher scores indicative of greater symptom severity. | All randomized participants are included, with multiple imputation of missing data. | Posted | | Number | 97.5% Confidence Interval | percentage of participants | | Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Roflumilast Foam 0.3% | Participants with plaque psoriasis of the scalp and body applied roflumilast foam 0.3% qd for 8 weeks. | | OG001 | Vehicle Foam | Participants with plaque psoriasis of the scalp and body applied vehicle foam qd for 8 weeks. |
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| Secondary | Achievement of S-IGA Success at Week 2 | The percentage of participants with S-IGA success at Week 2 is presented. Success is defined as an IGA score of 'clear' or 'almost clear' plus a 2-point improvement from baseline. This global assessment scale has five severity grades reported from 0-4 and defined as Clear (0), Almost Clear (1), Mild (2), Moderate (3), Severe (4), with higher scores indicative of greater symptom severity. | All randomized participants are included, with multiple imputation of missing data. | Posted | | Number | 97.5% Confidence Interval | percentage of participants | | Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Roflumilast Foam 0.3% | Participants with plaque psoriasis of the scalp and body applied roflumilast foam 0.3% qd for 8 weeks. | | OG001 | Vehicle Foam | Participants with plaque psoriasis of the scalp and body applied vehicle foam qd for 8 weeks. |
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| Secondary | Achievement of S-IGA Success at Week 4 | The percentage of participants with S-IGA success at Week 4 is presented. Success is defined as an IGA score of 'clear' or 'almost clear' plus a 2-point improvement from baseline. This global assessment scale has five severity grades reported from 0-4 and defined as Clear (0), Almost Clear (1), Mild (2), Moderate (3), Severe (4), with higher scores indicative of greater symptom severity. | All randomized participants are included, with multiple imputation of missing data. | Posted | | Number | 97.5% Confidence Interval | percentage of participants | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Roflumilast Foam 0.3% | Participants with plaque psoriasis of the scalp and body applied roflumilast foam 0.3% qd for 8 weeks. | | OG001 | Vehicle Foam | Participants with plaque psoriasis of the scalp and body applied vehicle foam qd for 8 weeks. |
| |
| Secondary | Change From Baseline in PASI Score at Week 2 | The Psoriasis Area and Severity Index (PASI) is widely used for the measurement of severity of psoriasis. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range from 0 (no disease) to 72 (maximal disease), with higher scores indicating greater symptom severity. A decrease from baseline indicates symptom improvement, and vice versa. | All randomized participants are included, with multiple imputation of missing data. | Posted | | Least Squares Mean | Standard Error | score on a scale | | Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Roflumilast Foam 0.3% | Participants with plaque psoriasis of the scalp and body applied roflumilast foam 0.3% qd for 8 weeks. | | OG001 | Vehicle Foam | Participants with plaque psoriasis of the scalp and body applied vehicle foam qd for 8 weeks. |
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