Seborrheic Dermatitis
Conditions
Brief summary
This was a parallel group, double blind, vehicle-controlled study assessed the safety and efficacy of roflumilast foam (ARQ-154) vs placebo foam in participants with seborrheic dermatitis.
Interventions
Roflumilast foam for topical application.
DRUGVehicle foam
Vehicle foam for topical application.
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
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Participants legally competent to sign and give informed consent. 2. Males and females ages 18 years and older (inclusive) at the time of consent. 3. Clinical diagnosis of seborrheic dermatitis of at least 3 months duration as determined by the Investigator. Stable disease for the past 4 weeks. 4. Seborrheic dermatitis of the scalp and/or face and/or trunk and/or intertriginous areas. 5. An Investigator Global Assessment (IGA) of disease severity of at least Moderate ('3') at Baseline. 6. Overall Assessment of Erythema and Overall Assessment of Scaling scores of at least Moderate ('2') at Baseline. 7. Females of childbearing potential (FOCBP) must have a negative serum pregnancy test at Screening (Visit 1) and a negative urine pregnancy test at Baseline (Visit 2). 8. Females of non-childbearing potential must either be post-menopausal with spontaneous amenorrhea for at least 12 months or have undergone surgical sterilization. 9. Subjects in good health as judged by the Investigator, based on medical history, physical examination, vital signs, serum chemistry labs, hematology values, and urinalysis. 10. Subjects are considered reliable and capable of adhering to the Protocol and visit schedule according to the Investigator judgment.
Exclusion criteria
1. Subjects who cannot discontinue treatment with therapies for the treatment of seborrheic dermatitis prior to the Baseline visit and during the study according to Excluded Medications and Treatments. 2. Planned excessive exposure of treated area(s) to either natural or artificial sunlight, tanning bed or other LED. 3. Subjects who cannot discontinue the use of strong P-450 cytochrome inhibitors e.g., indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketoconazole, nefazodone, saquinavir, suboxone and telithromycin for two weeks prior to the Baseline visit (Visit 2) and during the study. 4. Subjects who cannot discontinue the use of strong P-450 cytochrome inducers e.g., efavirenz, nevirapine, glucocorticoids, barbiturates (including phenobarbital), phenytoin, rifampin, and carbamazepine for two weeks prior to the Baseline visit (Visit 2) and during the study. 5. Subjects with PHQ-8 ≥10 at Screening or Baseline visits. 6. Previous treatment with ARQ-151 and ARQ-154. 7. Subjects who have received oral roflumilast (Daliresp®, Daxas®) or other PDE-4 inhibitors (apremilast) within the past 4 weeks. 8. Known allergies to excipients in ARQ-154 foam. 9. Known or suspected: severe renal insufficiency or moderate to severe hepatic disorders; hypersensitivity to component(s) of the investigational products; or history of severe depression, suicidal ideation, or Baseline/Screening C-SSRS indicative of suicidal ideation, whether lifetime or recent/current. 10. Subjects with a history of a major surgery within 8 weeks prior to Baseline (Visit 2) or has a major surgery planned during the study. 11. Subjects with any condition on the treatment area which, in the opinion of the Investigator, could confound efficacy measurements. 12. Subjects unable to apply product to the scalp due to physical limitations. 13. Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding. 14. A clinically relevant history of abuse of alcohol or other drugs, at the discretion of the Investigator. 15. Subjects who are unable to communicate, read or understand the local language, or who display another condition, which in the Investigator's opinion, makes them unsuitable for clinical study participation. 16. Subjects who are family members of the clinical study site, clinical study staff, or sponsor, or family members of enrolled subjects. 17. 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 Investigator Global Assessment (IGA) Success at Week 8 | Week 8 | The number of participants achieving success in IGA assessment of disease severity at Week 8 is presented for each arm. Success was defined as achievement of an IGA score of 0 ('completely clear') or 1 ('almost clear'), accompanied by a ≥2-grade improvement from baseline IGA score. The IGA is 5-point scale assessing the severity of Seborrheic Dermatitis, with scores ranging from 0 ('completely clear') to 4 ('severe'), and higher scores indicate greater severity. The IGA scores are based on observed data, whereas odds ratio and p-values were calculated using multiple imputation of missing values. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Overall Assessment of Erythema Score | Weeks 2, 4, and 8 | The mean (SD) change from baseline in Overall Assessment of Erythema score at Weeks 2, 4, and 8 is shown. The Erythema Assessment is a simple, single-item scale to assess the subject-reported severity of this symptom, on a scale ranging from 0 (None: no evidence of erythema.) to 3 (Severe: Intense \[fiery red\] erythema.). Higher scores indicate greater severity. |
| Achievement of Overall Assessment of Erythema Success | Weeks 2, 4, and 8 | The number of participants achieving success in Overall Assessment of Erythema at Weeks 2, 4, and 8 is presented for each arm. Success was defined as achievement of an overall score of 0 or 1 plus a ≥2 grade improvement from Baseline. The Overall Assessment of Erythema is a simple, single-item scale to assess the subject-reported severity of this symptom, on a scale ranging from 0 (None: no evidence of erythema.) to 3 (Severe: Intense \[fiery red\] erythema.). Higher scores indicate greater severity. |
| Change From Baseline in Overall Assessment of Scaling Score | Weeks 2, 4, and 8 | The mean (SD) change from baseline in Overall Assessment of Scaling score at Weeks 2, 4, and 8 is shown. The Overall Assessment of Scaling is a simple, single-item scale to assess the subject-reported severity of this symptom, on a scale ranging from 0 (No scaling: No scaling evident on lesions.) to 3 (Severe: Coarse, thick scales, with flaking into clothes or skin.). Higher scores indicate greater severity. |
| Achievement of IGA Success at Weeks 2 and 4 | Weeks 2 and 4 | The number of participants achieving success in IGA assessment of disease severity at Weeks 2 and 4 is presented for each arm. Success was defined as achievement of an IGA score of 0 ('completely clear') or 1 ('almost clear'), accompanied by a ≥2-grade improvement from baseline IGA score. The IGA is 5-point scale assessing the severity of Seborrheic Dermatitis, with scores ranging from 0 ('completely clear') to 4 ('severe'), and higher scores indicate greater severity. The IGA scores are based on observed data, whereas odds ratio and p-values were calculated using multiple imputation of missing values. |
| Change From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Score | Weeks 2, 4, and 8 | The change from baseline in WI-NRS is shown. The WI-NRS is a simple, single-item scale to assess the subject-reported severity of this symptom, on a scale ranging from 0 (no itch) to 10 (worst imaginable itch) the subject experienced in the previous 24 hours. Negative values represent a decrease in worst itch from baseline, and positive values indicate an increase. |
| Achievement of WI-NRS Success | Weeks 2, 4, and 8 | The number of participants achieving WI-NRS success at Weeks 2, 4, and 8 is presented. Success was defined as achievement of a ≥4-point improvement from baseline WI-NRS score. The WI-NRS is a simple, single-item scale to assess the subject-reported severity of this symptom, on a scale ranging from 0 (no itch) to 10 (worst imaginable itch) the subject experienced in the previous 24 hours. |
| Achievement of Overall Assessment of Scaling Success | Weeks 2, 4, and 8 | The number of participants achieving success in Overall Assessment of Scaling score at Weeks 2, 4, and 8 is presented for each arm. Success was defined as achievement of an Overall Assessment of Scaling score of 0 or 1 plus a ≥2 grade improvement from Baseline. The Overall Assessment of Scaling is a simple, single-item scale to assess the subject-reported severity of this symptom, on a scale ranging from 0 (No scaling: No scaling evident on lesions.) to 3 (Severe: Coarse, thick scales, with flaking into clothes or skin.). Higher scores indicate greater severity. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Roflumilast Foam 0.3% Participants apply roflumilast foam 0.3% once daily for 8 weeks. | 154 |
| Vehicle Foam Participants apply vehicle foam matched to roflumilast foam once daily for 8 weeks. | 72 |
| Total | 226 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 1 |
| Overall Study | Lost to Follow-up | 6 | 2 |
| Overall Study | Participant Incarcerated | 1 | 0 |
| Overall Study | Protocol Violation | 0 | 1 |
| Overall Study | Withdrawal by Subject | 4 | 1 |
Baseline characteristics
| Characteristic | Vehicle Foam | Roflumilast Foam 0.3% | Total |
|---|---|---|---|
| Age, Continuous | 44.2 years STANDARD_DEVIATION 16.27 | 45.3 years STANDARD_DEVIATION 17.01 | 44.9 years STANDARD_DEVIATION 16.75 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 16 Participants | 29 Participants | 45 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 56 Participants | 125 Participants | 181 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Investigator Global Assessment (IGA) Baseline Score 0 Completely Clear | 0 Participants | 0 Participants | 0 Participants |
| Investigator Global Assessment (IGA) Baseline Score 1 Almost Clear | 0 Participants | 0 Participants | 0 Participants |
| Investigator Global Assessment (IGA) Baseline Score 2 Mild | 0 Participants | 0 Participants | 0 Participants |
| Investigator Global Assessment (IGA) Baseline Score 3 Moderate | 69 Participants | 141 Participants | 210 Participants |
| Investigator Global Assessment (IGA) Baseline Score 4 Severe | 3 Participants | 13 Participants | 16 Participants |
| Overall Assessment of Erythema Baseline Score Mild | 0 Participants | 0 Participants | 0 Participants |
| Overall Assessment of Erythema Baseline Score Moderate | 66 Participants | 135 Participants | 201 Participants |
| Overall Assessment of Erythema Baseline Score None | 0 Participants | 0 Participants | 0 Participants |
| Overall Assessment of Erythema Baseline Score Severe | 6 Participants | 19 Participants | 25 Participants |
| Overall Assessment of Scaling Baseline Score Mild | 0 Participants | 0 Participants | 0 Participants |
| Overall Assessment of Scaling Baseline Score Moderate | 58 Participants | 130 Participants | 188 Participants |
| Overall Assessment of Scaling Baseline Score None | 0 Participants | 0 Participants | 0 Participants |
| Overall Assessment of Scaling Baseline Score Severe | 14 Participants | 24 Participants | 38 Participants |
| Race/Ethnicity, Customized American-Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 7 Participants | 8 Participants |
| Race/Ethnicity, Customized Black or African-American | 6 Participants | 17 Participants | 23 Participants |
| Race/Ethnicity, Customized More than One Race | 1 Participants | 5 Participants | 6 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized White | 62 Participants | 123 Participants | 185 Participants |
| Sex: Female, Male Female | 32 Participants | 78 Participants | 110 Participants |
| Sex: Female, Male Male | 40 Participants | 76 Participants | 116 Participants |
| Worst Itch Numerical Rating Scale (WI-NRS) Baseline Score 0 | 2 Participants | 7 Participants | 9 Participants |
| Worst Itch Numerical Rating Scale (WI-NRS) Baseline Score 1 | 2 Participants | 6 Participants | 8 Participants |
| Worst Itch Numerical Rating Scale (WI-NRS) Baseline Score 10 | 2 Participants | 9 Participants | 11 Participants |
| Worst Itch Numerical Rating Scale (WI-NRS) Baseline Score 2 | 5 Participants | 9 Participants | 14 Participants |
| Worst Itch Numerical Rating Scale (WI-NRS) Baseline Score 3 | 4 Participants | 7 Participants | 11 Participants |
| Worst Itch Numerical Rating Scale (WI-NRS) Baseline Score 4 | 8 Participants | 18 Participants | 26 Participants |
| Worst Itch Numerical Rating Scale (WI-NRS) Baseline Score 5 | 11 Participants | 13 Participants | 24 Participants |
| Worst Itch Numerical Rating Scale (WI-NRS) Baseline Score 6 | 5 Participants | 20 Participants | 25 Participants |
| Worst Itch Numerical Rating Scale (WI-NRS) Baseline Score 7 | 17 Participants | 27 Participants | 44 Participants |
| Worst Itch Numerical Rating Scale (WI-NRS) Baseline Score 8 | 16 Participants | 24 Participants | 40 Participants |
| Worst Itch Numerical Rating Scale (WI-NRS) Baseline Score 9 | 0 Participants | 14 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 154 | 0 / 72 |
| other Total, other adverse events | 0 / 154 | 0 / 72 |
| serious Total, serious adverse events | 0 / 154 | 0 / 72 |
Outcome results
Primary
Achievement of Investigator Global Assessment (IGA) Success at Week 8
The number of participants achieving success in IGA assessment of disease severity at Week 8 is presented for each arm. Success was defined as achievement of an IGA score of 0 ('completely clear') or 1 ('almost clear'), accompanied by a ≥2-grade improvement from baseline IGA score. The IGA is 5-point scale assessing the severity of Seborrheic Dermatitis, with scores ranging from 0 ('completely clear') to 4 ('severe'), and higher scores indicate greater severity. The IGA scores are based on observed data, whereas odds ratio and p-values were calculated using multiple imputation of missing values.
Time frame: Week 8
Population: All randomized participants are included, with the exception of those who missed the Week 8 assessment due to COVID-19 disruption.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Roflumilast Foam 0.3% | Achievement of Investigator Global Assessment (IGA) Success at Week 8 | 104 Participants |
| Vehicle Foam | Achievement of Investigator Global Assessment (IGA) Success at Week 8 | 27 Participants |
Comparison: IGA Success at Week 8 Odds Ratiop-value: <0.000195% CI: [2.51, 9.76]Cochran-Mantel-Haenszel
Secondary
Achievement of IGA Success at Weeks 2 and 4
The number of participants achieving success in IGA assessment of disease severity at Weeks 2 and 4 is presented for each arm. Success was defined as achievement of an IGA score of 0 ('completely clear') or 1 ('almost clear'), accompanied by a ≥2-grade improvement from baseline IGA score. The IGA is 5-point scale assessing the severity of Seborrheic Dermatitis, with scores ranging from 0 ('completely clear') to 4 ('severe'), and higher scores indicate greater severity. The IGA scores are based on observed data, whereas odds ratio and p-values were calculated using multiple imputation of missing values.
Time frame: Weeks 2 and 4
Population: All randomized participants are included, with the exception of those who missed the Week 8 assessment due to COVID-19 disruption.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Roflumilast Foam 0.3% | Achievement of IGA Success at Weeks 2 and 4 | Week 2 | 51 Participants |
| Roflumilast Foam 0.3% | Achievement of IGA Success at Weeks 2 and 4 | Week 4 | 81 Participants |
| Vehicle Foam | Achievement of IGA Success at Weeks 2 and 4 | Week 2 | 10 Participants |
| Vehicle Foam | Achievement of IGA Success at Weeks 2 and 4 | Week 4 | 19 Participants |
Comparison: IGA Success at Week 2 Odds Ratiop-value: 0.003395% CI: [1.46, 7.52]Cochran-Mantel-Haenszel
Comparison: IGA Success at Week 4 Odds Ratiop-value: 0.000295% CI: [1.94, 7.38]Cochran-Mantel-Haenszel
Secondary
Achievement of Overall Assessment of Erythema Success
The number of participants achieving success in Overall Assessment of Erythema at Weeks 2, 4, and 8 is presented for each arm. Success was defined as achievement of an overall score of 0 or 1 plus a ≥2 grade improvement from Baseline. The Overall Assessment of Erythema is a simple, single-item scale to assess the subject-reported severity of this symptom, on a scale ranging from 0 (None: no evidence of erythema.) to 3 (Severe: Intense \[fiery red\] erythema.). Higher scores indicate greater severity.
Time frame: Weeks 2, 4, and 8
Population: All randomized participants who provided data are included, with the exception of those who missed the Week 8 assessment due to COVID-19 disruption.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Roflumilast Foam 0.3% | Achievement of Overall Assessment of Erythema Success | Week 2 | 34 Participants |
| Roflumilast Foam 0.3% | Achievement of Overall Assessment of Erythema Success | Week 4 | 51 Participants |
| Roflumilast Foam 0.3% | Achievement of Overall Assessment of Erythema Success | Week 8 | 63 Participants |
| Vehicle Foam | Achievement of Overall Assessment of Erythema Success | Week 2 | 4 Participants |
| Vehicle Foam | Achievement of Overall Assessment of Erythema Success | Week 8 | 14 Participants |
| Vehicle Foam | Achievement of Overall Assessment of Erythema Success | Week 4 | 7 Participants |
Comparison: Erythema Success at Week 2p-value: 0.006595% CI: [1.49, 17.13]Cochran-Mantel-Haenszel
Comparison: Erythema Success at Week 4p-value: 0.000295% CI: [2.15, 13.38]Cochran-Mantel-Haenszel
Comparison: Erythema Success at Week 8p-value: 0.002195% CI: [1.5, 6.63]Cochran-Mantel-Haenszel
Secondary
Achievement of Overall Assessment of Scaling Success
The number of participants achieving success in Overall Assessment of Scaling score at Weeks 2, 4, and 8 is presented for each arm. Success was defined as achievement of an Overall Assessment of Scaling score of 0 or 1 plus a ≥2 grade improvement from Baseline. The Overall Assessment of Scaling is a simple, single-item scale to assess the subject-reported severity of this symptom, on a scale ranging from 0 (No scaling: No scaling evident on lesions.) to 3 (Severe: Coarse, thick scales, with flaking into clothes or skin.). Higher scores indicate greater severity.
Time frame: Weeks 2, 4, and 8
Population: All randomized participants who provided data are included, with the exception of those who missed the Week 8 assessment due to COVID-19 disruption.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Roflumilast Foam 0.3% | Achievement of Overall Assessment of Scaling Success | Week 2 | 40 Participants |
| Roflumilast Foam 0.3% | Achievement of Overall Assessment of Scaling Success | Week 4 | 59 Participants |
| Roflumilast Foam 0.3% | Achievement of Overall Assessment of Scaling Success | Week 8 | 63 Participants |
| Vehicle Foam | Achievement of Overall Assessment of Scaling Success | Week 8 | 14 Participants |
| Vehicle Foam | Achievement of Overall Assessment of Scaling Success | Week 2 | 10 Participants |
| Vehicle Foam | Achievement of Overall Assessment of Scaling Success | Week 4 | 14 Participants |
Comparison: Scaling Success at Week 2p-value: 0.075995% CI: [0.9, 4.33]Cochran-Mantel-Haenszel
Comparison: Scaling Success at Week 4p-value: 0.012295% CI: [1.18, 4.61]Cochran-Mantel-Haenszel
Comparison: Scaling Success at Week 8p-value: 0.000395% CI: [1.74, 6.55]Cochran-Mantel-Haenszel
Secondary
Achievement of WI-NRS Success
The number of participants achieving WI-NRS success at Weeks 2, 4, and 8 is presented. Success was defined as achievement of a ≥4-point improvement from baseline WI-NRS score. The WI-NRS is a simple, single-item scale to assess the subject-reported severity of this symptom, on a scale ranging from 0 (no itch) to 10 (worst imaginable itch) the subject experienced in the previous 24 hours.
Time frame: Weeks 2, 4, and 8
Population: All randomized participants who provided data are included, with the exception of those who missed the Week 8 assessment due to COVID-19 disruption or those with baseline WI-NRS \<4.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Roflumilast Foam 0.3% | Achievement of WI-NRS Success | Week 2 | 65 Participants |
| Roflumilast Foam 0.3% | Achievement of WI-NRS Success | Week 4 | 70 Participants |
| Roflumilast Foam 0.3% | Achievement of WI-NRS Success | Week 8 | 73 Participants |
| Vehicle Foam | Achievement of WI-NRS Success | Week 8 | 18 Participants |
| Vehicle Foam | Achievement of WI-NRS Success | Week 2 | 13 Participants |
| Vehicle Foam | Achievement of WI-NRS Success | Week 4 | 15 Participants |
Comparison: WI-NRS Success at Week 2p-value: 0.000795% CI: [1.72, 7.63]Cochran-Mantel-Haenszel
Comparison: WI-NRS Success at Week 4p-value: 0.000995% CI: [1.63, 6.68]Cochran-Mantel-Haenszel
Comparison: WI-NRS Success at Week 8p-value: 0.000795% CI: [1.6, 6.35]Cochran-Mantel-Haenszel
Secondary
Change From Baseline in Overall Assessment of Erythema Score
The mean (SD) change from baseline in Overall Assessment of Erythema score at Weeks 2, 4, and 8 is shown. The Erythema Assessment is a simple, single-item scale to assess the subject-reported severity of this symptom, on a scale ranging from 0 (None: no evidence of erythema.) to 3 (Severe: Intense \[fiery red\] erythema.). Higher scores indicate greater severity.
Time frame: Weeks 2, 4, and 8
Population: All randomized participants who provided data are included, with the exception of those who missed the Week 8 assessment due to COVID-19 disruption.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Roflumilast Foam 0.3% | Change From Baseline in Overall Assessment of Erythema Score | Week 2 | -1.0 score on a scale | Standard Deviation 0.73 |
| Roflumilast Foam 0.3% | Change From Baseline in Overall Assessment of Erythema Score | Week 4 | -1.3 score on a scale | Standard Deviation 0.73 |
| Roflumilast Foam 0.3% | Change From Baseline in Overall Assessment of Erythema Score | Week 8 | -1.4 score on a scale | Standard Deviation 0.78 |
| Vehicle Foam | Change From Baseline in Overall Assessment of Erythema Score | Week 2 | -0.4 score on a scale | Standard Deviation 0.65 |
| Vehicle Foam | Change From Baseline in Overall Assessment of Erythema Score | Week 4 | -0.7 score on a scale | Standard Deviation 0.68 |
| Vehicle Foam | Change From Baseline in Overall Assessment of Erythema Score | Week 8 | -0.8 score on a scale | Standard Deviation 0.85 |
Comparison: Week 2 Erythema Scorep-value: <0.0001Wilcoxon (Mann-Whitney)
Comparison: Week 4 Erythema Scorep-value: <0.0001Wilcoxon (Mann-Whitney)
Comparison: Week 8 Erythema Scorep-value: <0.0001Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in Overall Assessment of Scaling Score
The mean (SD) change from baseline in Overall Assessment of Scaling score at Weeks 2, 4, and 8 is shown. The Overall Assessment of Scaling is a simple, single-item scale to assess the subject-reported severity of this symptom, on a scale ranging from 0 (No scaling: No scaling evident on lesions.) to 3 (Severe: Coarse, thick scales, with flaking into clothes or skin.). Higher scores indicate greater severity.
Time frame: Weeks 2, 4, and 8
Population: All randomized participants who provided data are included, with the exception of those who missed the Week 8 assessment due to COVID-19 disruption.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Roflumilast Foam 0.3% | Change From Baseline in Overall Assessment of Scaling Score | Week 2 | -1.0 Score on a scale | Standard Deviation 0.77 |
| Roflumilast Foam 0.3% | Change From Baseline in Overall Assessment of Scaling Score | Week 4 | -1.3 Score on a scale | Standard Deviation 0.76 |
| Roflumilast Foam 0.3% | Change From Baseline in Overall Assessment of Scaling Score | Week 8 | -1.5 Score on a scale | Standard Deviation 0.75 |
| Vehicle Foam | Change From Baseline in Overall Assessment of Scaling Score | Week 2 | -0.6 Score on a scale | Standard Deviation 0.78 |
| Vehicle Foam | Change From Baseline in Overall Assessment of Scaling Score | Week 4 | -0.8 Score on a scale | Standard Deviation 0.81 |
| Vehicle Foam | Change From Baseline in Overall Assessment of Scaling Score | Week 8 | -1.0 Score on a scale | Standard Deviation 0.83 |
Comparison: Week 2 Scaling Scorep-value: <0.0001Wilcoxon (Mann-Whitney)
Comparison: Week 4 Scaling Scorep-value: <0.0001Wilcoxon (Mann-Whitney)
Comparison: Week 8 Scaling Scorep-value: <0.0001Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Score
The change from baseline in WI-NRS is shown. The WI-NRS is a simple, single-item scale to assess the subject-reported severity of this symptom, on a scale ranging from 0 (no itch) to 10 (worst imaginable itch) the subject experienced in the previous 24 hours. Negative values represent a decrease in worst itch from baseline, and positive values indicate an increase.
Time frame: Weeks 2, 4, and 8
Population: All randomized participants who provided data are included, with the exception of those who missed the Week 8 assessment due to COVID-19 disruption.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Roflumilast Foam 0.3% | Change From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Score | Week 2 | -3.0 score on a scale | Standard Deviation 2.8 |
| Roflumilast Foam 0.3% | Change From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Score | Week 4 | -3.5 score on a scale | Standard Deviation 2.72 |
| Roflumilast Foam 0.3% | Change From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Score | Week 8 | -3.7 score on a scale | Standard Deviation 2.83 |
| Vehicle Foam | Change From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Score | Week 8 | -2.0 score on a scale | Standard Deviation 2.37 |
| Vehicle Foam | Change From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Score | Week 2 | -1.7 score on a scale | Standard Deviation 2.08 |
| Vehicle Foam | Change From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Score | Week 4 | -1.9 score on a scale | Standard Deviation 2.22 |