Scalp Psoriasis
Conditions
Brief summary
This was a parallel group, double blind, vehicle-controlled study to assess the safety and efficacy of roflumilast (ARQ-154) 0.3% foam vs vehicle foam applied once daily (qd) for 8 weeks by participants with plaque psoriasis of the scalp and body.
Interventions
Roflumilast foam 0.3%
DRUGVehicle Foam
Vehicle foam matched to roflumilast 0.3% foam.
Sponsors
Arcutis Biotherapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* For adult subjects: Participants legally competent to read, write, and sign and give informed consent. For adolescent subjects: Informed consent of a parent(s) or legal guardian, and assent by the subjects, as required by local laws. * Males and females ages 12 years and older (inclusive) at the time of consent or assent. * Scalp psoriasis with a Scalp-Investigator Global Assessment of Disease (S IGA) severity of at least Moderate ('3') at Baseline. * Extent of scalp psoriasis involving ≥ 10% of the total scalp at Baseline. * A Psoriasis Scalp Severity Index (PSSI) of at least 6 at Baseline. * An IGA of body (i.e., non-scalp) psoriasis (B-IGA) of at least Mild ('2') at Baseline. * A PASI score of at least 2 (excluding palms and soles) at Baseline. * Clinical diagnosis of psoriasis vulgaris of at least 6 months duration at Screening as determined by the Investigator. Stable disease for the past 4 weeks. * Total overall psoriasis involvement on scalp and non-scalp areas ≤ 25% BSA (not including palms/soles) at Baseline. Total non-scalp BSA should not exceed 20%. * Female subject of childbearing potential (FOCBP) must have a negative serum pregnancy test at Screening (Visit 1) and negative urine pregnancy test at Baseline (Visit 2). In addition, sexually active FOCBP must agree to use at least one form of highly effective contraception or a barrier method of contraception throughout the study according to Contraception Requirements for the protocol. * Females of non-childbearing potential must either be premenarchal, post-menopausal with spontaneous amenorrhea for at least 12 months (post-menopausal status will be confirmed with FSH testing) or have undergone surgical sterilization according to Contraception Requirements for the protocol. Prepubescent females must agree to be abstinent during the study. * Subjects in good health as judged by the Investigator, based on medical history, physical examination, vital signs, serum chemistry labs, hematology values, and urinalysis.
Exclusion criteria
* Subjects who cannot discontinue treatment with therapies for the treatment of psoriasis vulgaris prior to the Baseline visit and during the study. * Planned excessive exposure to treated area(s) to either natural or artificial sunlight, tanning bed, or other LED. * Previous treatment with ARQ-151 or ARQ-154. * Females who are pregnant, wishing to become pregnant during the study, or are breast feeding. * Subjects with any serious medical condition or laboratory abnormality that would prevent study participation or place the subject at significant risk, as determined by the Investigator. * Subjects who are family members of the clinical study site, clinical study staff, or sponsor, or family members residing in the same household of enrolled subjects. * Any condition that in the Investigator's assessment would preclude the subject from participating in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Achievement of Scalp Investigator Global Assessment (S-IGA) Success at Week 8 | 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. |
| Achievement of Body Investigator Global Assessment (B-IGA) Success at Week 8 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Achievement of SI-NRS Success at Week 8 | 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. |
| Change From Baseline in SI-NRS Score at Day 1 | 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. |
| Change From Baseline in SI-NRS Score at Day 3 | 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. |
| Change From Baseline in SI-NRS Score at Week 1 | 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. |
| Achievement of WI-NRS (Worst Itch-Numeric Rating Score) Success at Week 8 | 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. |
| Achievement of a 75% Reduction From Baseline in Psoriasis Area and Severity Index (PASI-75) | Week 8 | 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. |
| Change From Baseline in Psoriasis Symptoms Diary (PSD) Aggregate Score of Itching, Pain, and Scaling (Questions 1, 9, and 11) | 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 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. |
| Percentage of Participants Achieving PSD Itching (Question 1) Score of 0 at Week 8 | 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. |
| Achievement of Scalp Itch-Numeric Rating Score (SI-NRS ) Success at Week 2 | 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. |
| Percentage of Participants Achieving PSD Scaling (Question 11) Score of 0 at Week 8 | 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. |
| Percentage of Participants Achieving PSD Total Score of 0 at Week 8 | Week 8 | — |
| Achievement of a 75% Reduction From Baseline in Psoriasis Scalp Severity Index (PSSI) Score (PSSI-75) | Week 8 | 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). |
| Achievement of S-IGA Score of 'Clear' at Week 8 | 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. |
| Achievement of S-IGA Success at Week 2 | 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. |
| Achievement of S-IGA Success at Week 4 | 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. |
| Change From Baseline in PASI Score at Week 2 | 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. |
| Percentage of Participants Achieving PSD Pain (Question 9) Score of 0 at Week 8 | 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. |
| Achievement of SI-NRS Success at Week 4 | 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. |
Countries
Canada, United States
Participant flow
Pre-assignment details
Participants were enrolled at 53 study centers in the US and Canada.
Participants by arm
| Arm | Count |
|---|---|
| Roflumilast Foam 0.3% Participants with plaque psoriasis of the scalp and body applied roflumilast foam 0.3% qd for 8 weeks. | 281 |
| Vehicle Foam Participants with plaque psoriasis of the scalp and body applied vehicle foam qd for 8 weeks. | 151 |
| Total | 432 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 5 | 2 |
| Overall Study | Lack of Efficacy | 3 | 1 |
| Overall Study | Lost to Follow-up | 11 | 9 |
| Overall Study | Miscellaneous | 3 | 2 |
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Withdrawal by Subject | 9 | 10 |
Baseline characteristics
| Characteristic | Vehicle Foam | Total | Roflumilast Foam 0.3% |
|---|---|---|---|
| Age, Continuous | 45.0 years STANDARD_DEVIATION 14.33 | 47.3 years STANDARD_DEVIATION 14.81 | 48.6 years STANDARD_DEVIATION 14.93 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 28 Participants | 76 Participants | 48 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 121 Participants | 345 Participants | 224 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 11 Participants | 9 Participants |
| Race/Ethnicity, Customized American-Indian or Alaska Native | 3 Participants | 3 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 4 Participants | 30 Participants | 26 Participants |
| Race/Ethnicity, Customized Black or African-American | 6 Participants | 18 Participants | 12 Participants |
| Race/Ethnicity, Customized More than One Race | 1 Participants | 5 Participants | 4 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 Participants | 4 Participants | 3 Participants |
| Race/Ethnicity, Customized Other | 7 Participants | 18 Participants | 11 Participants |
| Race/Ethnicity, Customized White | 129 Participants | 354 Participants | 225 Participants |
| Sex: Female, Male Female | 91 Participants | 243 Participants | 152 Participants |
| Sex: Female, Male Male | 60 Participants | 189 Participants | 129 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 281 | 0 / 151 |
| other Total, other adverse events | 0 / 281 | 0 / 151 |
| serious Total, serious adverse events | 2 / 281 | 1 / 151 |
Outcome results
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.
Time frame: Week 8
Population: All randomized participants are included, with multiple imputation of missing data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Roflumilast Foam 0.3% | Achievement of Body Investigator Global Assessment (B-IGA) Success at Week 8 | 45.5 percentage of participants |
| Vehicle Foam | Achievement of Body Investigator Global Assessment (B-IGA) Success at Week 8 | 20.1 percentage of participants |
Comparison: B-IGA Success at Week 8p-value: <0.000197.5% CI: [1.75, 5.73]Cochran-Mantel-Haenszel
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.
Time frame: Week 8
Population: All randomized participants are included, with multiple imputation of missing data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Roflumilast Foam 0.3% | Achievement of Scalp Investigator Global Assessment (S-IGA) Success at Week 8 | 66.4 percentage of participants |
| Vehicle Foam | Achievement of Scalp Investigator Global Assessment (S-IGA) Success at Week 8 | 27.8 percentage of participants |
Comparison: S-IGA Success at Week 8p-value: <0.000197.5% CI: [2.9, 9.31]Cochran-Mantel-Haenszel
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.
Time frame: Week 8
Population: All randomized participants are included, with multitple imputation of missing data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Roflumilast Foam 0.3% | Achievement of a 75% Reduction From Baseline in Psoriasis Area and Severity Index (PASI-75) | 50.1 percentage of participants |
| Vehicle Foam | Achievement of a 75% Reduction From Baseline in Psoriasis Area and Severity Index (PASI-75) | 16.8 percentage of participants |
p-value: <0.000197.5% CI: [2.73, 10.75]Cochran-Mantel-Haenszel
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).
Time frame: Week 8
Population: All randomized participants are included, with multiple imputation of missing data..
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Roflumilast Foam 0.3% | Achievement of a 75% Reduction From Baseline in Psoriasis Scalp Severity Index (PSSI) Score (PSSI-75) | 70.9 percentage of participants |
| Vehicle Foam | Achievement of a 75% Reduction From Baseline in Psoriasis Scalp Severity Index (PSSI) Score (PSSI-75) | 31.3 percentage of participants |
p-value: <0.000197.5% CI: [2.98, 9.77]Cochran-Mantel-Haenszel
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.
Time frame: Week 2
Population: All randomized participants with weekly average baseline SI-NRS ≥4 are included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Roflumilast Foam 0.3% | Achievement of Scalp Itch-Numeric Rating Score (SI-NRS ) Success at Week 2 | 25.2 percentage of participants |
| Vehicle Foam | Achievement of Scalp Itch-Numeric Rating Score (SI-NRS ) Success at Week 2 | 8.0 percentage of participants |
p-value: 0.000597.5% CI: [1.6, 13.62]Cochran-Mantel-Haenszel
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.
Time frame: Week 8
Population: All randomized participants are included, with multiple imputation of missing data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Roflumilast Foam 0.3% | Achievement of S-IGA Score of 'Clear' at Week 8 | 40.0 percentage of participants |
| Vehicle Foam | Achievement of S-IGA Score of 'Clear' at Week 8 | 9.1 percentage of participants |
p-value: <0.000197.5% CI: [3.04, 15.05]Cochran-Mantel-Haenszel
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.
Time frame: Week 2
Population: All randomized participants are included, with multiple imputation of missing data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Roflumilast Foam 0.3% | Achievement of S-IGA Success at Week 2 | 30.4 percentage of participants |
| Vehicle Foam | Achievement of S-IGA Success at Week 2 | 11.7 percentage of participants |
p-value: <0.000197.5% CI: [1.84, 9.13]Cochran-Mantel-Haenszel
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.
Time frame: Week 4
Population: All randomized participants are included, with multiple imputation of missing data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Roflumilast Foam 0.3% | Achievement of S-IGA Success at Week 4 | 53.8 percentage of participants |
| Vehicle Foam | Achievement of S-IGA Success at Week 4 | 19.5 percentage of participants |
p-value: <0.000197.5% CI: [2.62, 8.84]Cochran-Mantel-Haenszel
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.
Time frame: Week 4
Population: All randomized participants with weekly average baseline SI-NRS ≥4 are included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Roflumilast Foam 0.3% | Achievement of SI-NRS Success at Week 4 | 46.2 percentage of participants |
| Vehicle Foam | Achievement of SI-NRS Success at Week 4 | 16.8 percentage of participants |
Comparison: SI-NRS Success at Week 4p-value: <0.000197.5% CI: [2.01, 9.55]Cochran-Mantel-Haenszel
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.
Time frame: Week 8
Population: All randomized participants with weekly average baseline SI-NRS ≥4 are included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Roflumilast Foam 0.3% | Achievement of SI-NRS Success at Week 8 | 65.3 percentage of participants |
| Vehicle Foam | Achievement of SI-NRS Success at Week 8 | 30.3 percentage of participants |
p-value: <0.000197.5% CI: [2.49, 11.78]Cochran-Mantel-Haenszel
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.
Time frame: Week 8
Population: All randomized participants with average, weekly WI-NRS ≥4 at baseline are included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Roflumilast Foam 0.3% | Achievement of WI-NRS (Worst Itch-Numeric Rating Score) Success at Week 8 | 63.1 percentage of participants |
| Vehicle Foam | Achievement of WI-NRS (Worst Itch-Numeric Rating Score) Success at Week 8 | 30.1 percentage of participants |
p-value: <0.000197.5% CI: [2.01, 8.52]Cochran-Mantel-Haenszel
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.
Time frame: Week 2
Population: All randomized participants are included, with multiple imputation of missing data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Roflumilast Foam 0.3% | Change From Baseline in PASI Score at Week 2 | -2.31 score on a scale | Standard Error 0.157 |
| Vehicle Foam | Change From Baseline in PASI Score at Week 2 | -1.03 score on a scale | Standard Error 0.193 |
p-value: <0.000197.5% CI: [-1.71, -0.85]ANCOVA
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.
Time frame: Week 8
Population: All randomized participants ≥18 years of age are included.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Roflumilast Foam 0.3% | Change From Baseline in Psoriasis Symptoms Diary (PSD) Aggregate Score of Itching, Pain, and Scaling (Questions 1, 9, and 11) | -10.87 score on a scale | Standard Error 0.546 |
| Vehicle Foam | Change From Baseline in Psoriasis Symptoms Diary (PSD) Aggregate Score of Itching, Pain, and Scaling (Questions 1, 9, and 11) | -5.75 score on a scale | Standard Error 0.698 |
p-value: <0.000197.5% CI: [-6.64, -3.6]ANCOVA
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.
Time frame: Day 1
Population: All randomized participants with average, weekly SI-NRS ≥4 at baseline are included.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Roflumilast Foam 0.3% | Change From Baseline in SI-NRS Score at Day 1 | -0.44 score on a scale | Standard Error 0.12 |
| Vehicle Foam | Change From Baseline in SI-NRS Score at Day 1 | -0.09 score on a scale | Standard Error 0.149 |
p-value: 0.016497.5% CI: [-0.68, -0.02]ANCOVA
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.
Time frame: Day 3
Population: All randomized participants are included.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Roflumilast Foam 0.3% | Change From Baseline in SI-NRS Score at Day 3 | -1.11 score on a scale | Standard Error 0.133 |
| Vehicle Foam | Change From Baseline in SI-NRS Score at Day 3 | -0.36 score on a scale | Standard Error 0.165 |
p-value: <0.000197.5% CI: [-1.12, -0.39]ANCOVA
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.
Time frame: Week 1
Population: All randomized participants are included.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Roflumilast Foam 0.3% | Change From Baseline in SI-NRS Score at Week 1 | -1.08 score on a scale | Standard Error 0.121 |
| Vehicle Foam | Change From Baseline in SI-NRS Score at Week 1 | -0.53 score on a scale | Standard Error 0.151 |
p-value: 0.000297.5% CI: [-0.87, -0.22]ANCOVA
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.
Time frame: Week 8
Population: All randomized participants ≥18 years of age are included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Roflumilast Foam 0.3% | Percentage of Participants Achieving PSD Itching (Question 1) Score of 0 at Week 8 | 31.7 percentage of participants |
| Vehicle Foam | Percentage of Participants Achieving PSD Itching (Question 1) Score of 0 at Week 8 | 10.0 percentage of participants |
p-value: <0.000197.5% CI: [2.1, 10.04]Cochran-Mantel-Haenszel
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.
Time frame: Week 8
Population: All randomized participants ≥18 years of age are included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Roflumilast Foam 0.3% | Percentage of Participants Achieving PSD Pain (Question 9) Score of 0 at Week 8 | 64.9 percentage of participants |
| Vehicle Foam | Percentage of Participants Achieving PSD Pain (Question 9) Score of 0 at Week 8 | 40.3 percentage of participants |
p-value: <0.000197.5% CI: [1.83, 5.68]Cochran-Mantel-Haenszel
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.
Time frame: Week 8
Population: All randomized participants ≥18 years of age are included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Roflumilast Foam 0.3% | Percentage of Participants Achieving PSD Scaling (Question 11) Score of 0 at Week 8 | 41.5 percentage of participants |
| Vehicle Foam | Percentage of Participants Achieving PSD Scaling (Question 11) Score of 0 at Week 8 | 13.6 percentage of participants |
p-value: <0.000197.5% CI: [2.28, 9.08]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving PSD Total Score of 0 at Week 8
Time frame: Week 8
Population: All randomized participants ≥18 years of age are included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Roflumilast Foam 0.3% | Percentage of Participants Achieving PSD Total Score of 0 at Week 8 | 19.6 percentage of participants |
| Vehicle Foam | Percentage of Participants Achieving PSD Total Score of 0 at Week 8 | 7.1 percentage of participants |
p-value: 0.001297.5% CI: [1.39, 7.68]Cochran-Mantel-Haenszel