Seborrheic Dermatitis
Conditions
Brief summary
This phase 3, double-blind, vehicle-controlled study assessed the safety and efficacy of roflumilast (ARQ-154) foam 0.3% applied once daily (qd) for 8 weeks by participants with seborrheic dermatitis.
Interventions
DRUGRoflumilast Foam
Roflumilast 0.3% 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
9 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Participants legally competent to sign and give informed consent and, if appropriate, assent as required by local laws. * Males and females ages 9 years and older at the time of consent. * Clinical diagnosis of seborrheic dermatitis of at least 3 months duration at Screening as determined by the Investigator. Stable disease for the past 4 weeks. * Seborrheic dermatitis up to 20% BSA involvement. Involvement may be of the scalp and/or face and/or trunk and/or intertriginous areas. * An Investigator Global Assessment (IGA) disease severity of at least Moderate ('3') at Baseline. * Overall Assessment of Erythema and Overall Assessment of Scaling scores of at least Moderate ('2') at Baseline. * 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). * Females of non-childbearing potential must either be post-menopausal with spontaneous amenorrhea for at least 12 months or have undergone surgical sterilization. * Subjects in good health as judged by the Investigator. * Subjects are considered reliable and capable of adhering to the Protocol and visit schedule according to the Investigator judgment. Key
Exclusion criteria
* Subjects who cannot discontinue treatment with therapies for the treatment of seborrheic dermatitis prior to the Baseline visit and during the study. * Planned excessive exposure of treated area(s) to either natural or artificial sunlight, tanning bed or other LED. * Previous treatment with ARQ-154 or ARQ-151. * Subjects with any serious medical condition or clinically significant abnormality that would prevent study participation or place the subject at significant risk, as judged by the Investigator. * Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding. * Subjects with a history of chronic alcohol or drug abuse within 6 months prior to Screening. * Subjects, parent(s)/legal guardian(s) who are unable to communicate, read, or understand the local language(s). * Subjects who are family members of the clinical study site, clinical study staff, or sponsor, or family members living in the same house of enrolled subjects.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Achievement of Success on the Investigator Global Assessment (IGA) at Week 8 | Week 8 | The percentage of participants achieving IGA success is presented. Success is defined as a score of 0 ('clear') or 1 ('almost clear') plus a 2-point improvement at Week 8. The IGA is 5-point scale assessing the severity of seborrheic dermatitis with total scores ranging from 0 ('clear') to 4 ('severe') \[higher scores indicating greater severity\]. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Achievement of Success in the WI-NRS at Week 4 | Week 4 | The percentage of participants achieving WI-NRS success is presented. The WI-NRS is a simple, single-item scale to assess the participant-reported severity of this symptom, on a scale ranging from 0 (no itch) to 10 (worst imaginable itch) the participants experienced in the previous 24 hours (higher scores indicate higher itch severity). The endpoint is the average of daily assessments reported during each study week, and requires at least 4 daily assessments reported during the week. In participants with a weekly average baseline pruritus score of ≥4, success is defined as achievement of a ≥4-point improvement from baseline in weekly average WI-NRS pruritus score at Week 4. |
| Achievement of Success in the WI-NRS at Week 2 | Week 2 | The percentage of participants achieving WI-NRS success is presented. In participants with a weekly average baseline pruritus score of ≥4, success is defined as achievement of a ≥4-point improvement from baseline in weekly average WI-NRS pruritus score at Week 2. The endpoint is the average of daily assessments reported during each study week, and requires at least 4 daily assessments reported during the week. The WI-NRS is a simple, single-item scale to assess the participant-reported severity of this symptom, on a scale ranging from 0 (no itch) to 10 (worst imaginable itch) the participants experienced in the previous 24 hours (higher scores indicate higher itch severity). |
| Achievement of Success on the IGA at Week 2 | Week 2 | The percentage of participants achieving WI-NRS success is presented. The WI-NRS is a simple, single-item scale to assess the participant-reported severity of this symptom, on a scale ranging from 0 (no itch) to 10 (worst imaginable itch) the participants experienced in the previous 24 hours (higher scores indicate higher itch severity). The endpoint is the average of daily assessments reported during each study week, and requires at least 4 daily assessments reported during the week. In participants with a weekly average baseline pruritus score of ≥4, success is defined as achievement of a ≥4-point improvement from baseline in weekly average WI-NRS pruritus score at Week 2. |
| Achievement of Success in the Worst Itch Numeric Rating Scale (WI-NRS) at Week 8 | Week 8 | The percentage of participants achieving WI-NRS success is presented. The WI-NRS is a simple, single-item scale to assess the participant-reported severity of this symptom, on a scale ranging from 0 (no itch) to 10 (worst imaginable itch) the participants experienced in the previous 24 hours (higher scores indicate higher itch severity). The endpoint is the average of daily assessments reported during each study week, and requires at least 4 daily assessments reported during the week. In participants with a weekly average baseline pruritus score of ≥4, success is defined as achievement of a ≥4-point improvement from baseline in weekly average WI-NRS pruritus score at Week 8. |
| Achievement of Overall Assessment of Scaling Score of 0 at Week 8 | Week 8 | The percentage of participants achieving Overall Assessment of Scaling score of 0 at Week 8 is presented. 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 symptom severity. |
| Achievement of Overall Assessment of Erythema Score of 0 at Week 8 | Week 8 | The percentage of participants achieving Overall Assessment of Erythema score of 0 at Week 8 is presented. 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 Success on the IGA at Week 4 | Week 4 | The percentage of participants achieving IGA success is presented. Success is defined as a score of 0 ('clear') or 1 ('almost clear') plus a 2-point improvement at Week 8. The IGA is 5-point scale assessing the severity of seborrheic dermatitis with total scores ranging from 0 ('clear') to 4 ('severe') \[higher scores indicating greater severity\]. |
Countries
Canada, United States
Participant flow
Pre-assignment details
Participants were enrolled at 50 study centers in the US and Canada.
Participants by arm
| Arm | Count |
|---|---|
| Roflumilast Foam 0.3% Participants with seborrheic dermatitis applied roflumilast foam 0.3% once daily (QD) for 8 weeks. | 304 |
| Vehicle Foam Participants with seborrheic dermatitis applied vehicle foam QD for 8 weeks. | 153 |
| Total | 457 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 3 |
| Overall Study | Did not tolerate application | 1 | 0 |
| Overall Study | Lack of Efficacy | 1 | 3 |
| Overall Study | Lost to Follow-up | 12 | 4 |
| Overall Study | Missed visits due to new work schedule | 1 | 0 |
| Overall Study | Wanted to early terminate and use own product | 0 | 1 |
| Overall Study | Withdrawal by Subject | 11 | 4 |
Baseline characteristics
| Characteristic | Total | Vehicle Foam | Roflumilast Foam 0.3% |
|---|---|---|---|
| Age, Continuous | 42.7 years STANDARD_DEVIATION 17.03 | 41.8 years STANDARD_DEVIATION 17.47 | 43.2 years STANDARD_DEVIATION 16.81 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 97 Participants | 28 Participants | 69 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 360 Participants | 125 Participants | 235 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 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 | 428 Participants | 141 Participants | 287 Participants |
| Investigator Global Assessment (IGA) Baseline Score 4 - Severe | 29 Participants | 12 Participants | 17 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 4 Participants | 0 Participants | 4 Participants |
| Race/Ethnicity, Customized Asian | 28 Participants | 10 Participants | 18 Participants |
| Race/Ethnicity, Customized Black or African American | 51 Participants | 15 Participants | 36 Participants |
| Race/Ethnicity, Customized More than one race | 2 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 15 Participants | 4 Participants | 11 Participants |
| Race/Ethnicity, Customized White | 356 Participants | 122 Participants | 234 Participants |
| Sex: Female, Male Female | 229 Participants | 78 Participants | 151 Participants |
| Sex: Female, Male Male | 228 Participants | 75 Participants | 153 Participants |
| Worst Itch Numerical Rating Scale (WI-NRS) Baseline Score 0 | 29 Participants | 9 Participants | 20 Participants |
| Worst Itch Numerical Rating Scale (WI-NRS) Baseline Score 1 | 27 Participants | 14 Participants | 13 Participants |
| Worst Itch Numerical Rating Scale (WI-NRS) Baseline Score 10 | 18 Participants | 6 Participants | 12 Participants |
| Worst Itch Numerical Rating Scale (WI-NRS) Baseline Score 2 | 32 Participants | 10 Participants | 22 Participants |
| Worst Itch Numerical Rating Scale (WI-NRS) Baseline Score 3 | 51 Participants | 16 Participants | 35 Participants |
| Worst Itch Numerical Rating Scale (WI-NRS) Baseline Score 4 | 41 Participants | 15 Participants | 26 Participants |
| Worst Itch Numerical Rating Scale (WI-NRS) Baseline Score 5 | 63 Participants | 20 Participants | 43 Participants |
| Worst Itch Numerical Rating Scale (WI-NRS) Baseline Score 6 | 62 Participants | 22 Participants | 40 Participants |
| Worst Itch Numerical Rating Scale (WI-NRS) Baseline Score 7 | 56 Participants | 17 Participants | 39 Participants |
| Worst Itch Numerical Rating Scale (WI-NRS) Baseline Score 8 | 49 Participants | 16 Participants | 33 Participants |
| Worst Itch Numerical Rating Scale (WI-NRS) Baseline Score 9 | 21 Participants | 7 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 304 | 0 / 153 |
| other Total, other adverse events | 0 / 304 | 0 / 153 |
| serious Total, serious adverse events | 1 / 304 | 0 / 153 |
Outcome results
Primary
Achievement of Success on the Investigator Global Assessment (IGA) at Week 8
The percentage of participants achieving IGA success is presented. Success is defined as a score of 0 ('clear') or 1 ('almost clear') plus a 2-point improvement at Week 8. The IGA is 5-point scale assessing the severity of seborrheic dermatitis with total scores ranging from 0 ('clear') to 4 ('severe') \[higher scores indicating greater severity\].
Time frame: Week 8
Population: All randomized participants are included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Roflumilast Foam 0.3% | Achievement of Success on the Investigator Global Assessment (IGA) at Week 8 | 80 percentage of participants |
| Vehicle Foam | Achievement of Success on the Investigator Global Assessment (IGA) at Week 8 | 58 percentage of participants |
Comparison: IGA Success at Week 8p-value: <0.000195% CI: [1.75, 4.45]Cochran-Mantel-Haenszel
Secondary
Achievement of Overall Assessment of Erythema Score of 0 at Week 8
The percentage of participants achieving Overall Assessment of Erythema score of 0 at Week 8 is presented. 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: Week 8
Population: All randomized participants are included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Roflumilast Foam 0.3% | Achievement of Overall Assessment of Erythema Score of 0 at Week 8 | 58 percentage of participants |
| Vehicle Foam | Achievement of Overall Assessment of Erythema Score of 0 at Week 8 | 32 percentage of participants |
Comparison: Erythema Score of 0 at Week 8p-value: <0.000195% CI: [2.05, 5.06]Cochran-Mantel-Haenszel
Secondary
Achievement of Overall Assessment of Scaling Score of 0 at Week 8
The percentage of participants achieving Overall Assessment of Scaling score of 0 at Week 8 is presented. 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 symptom severity.
Time frame: Week 8
Population: All randomized participants are included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Roflumilast Foam 0.3% | Achievement of Overall Assessment of Scaling Score of 0 at Week 8 | 58 percentage of participants |
| Vehicle Foam | Achievement of Overall Assessment of Scaling Score of 0 at Week 8 | 37 percentage of participants |
Comparison: Scaling Score of 0 at Week 8p-value: <0.000195% CI: [1.56, 3.73]Cochran-Mantel-Haenszel
Secondary
Achievement of Success in the WI-NRS at Week 2
The percentage of participants achieving WI-NRS success is presented. In participants with a weekly average baseline pruritus score of ≥4, success is defined as achievement of a ≥4-point improvement from baseline in weekly average WI-NRS pruritus score at Week 2. The endpoint is the average of daily assessments reported during each study week, and requires at least 4 daily assessments reported during the week. The WI-NRS is a simple, single-item scale to assess the participant-reported severity of this symptom, on a scale ranging from 0 (no itch) to 10 (worst imaginable itch) the participants experienced in the previous 24 hours (higher scores indicate higher itch severity).
Time frame: Week 2
Population: All randomized participants with a weekly baseline average WI-NRS score ≥4 are included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Roflumilast Foam 0.3% | Achievement of Success in the WI-NRS at Week 2 | 33 percentage of participants |
| Vehicle Foam | Achievement of Success in the WI-NRS at Week 2 | 16 percentage of participants |
Comparison: WI-NRS Success at Week 2p-value: 0.001695% CI: [1.41, 5.34]Cochran-Mantel-Haenszel
Secondary
Achievement of Success in the WI-NRS at Week 4
The percentage of participants achieving WI-NRS success is presented. The WI-NRS is a simple, single-item scale to assess the participant-reported severity of this symptom, on a scale ranging from 0 (no itch) to 10 (worst imaginable itch) the participants experienced in the previous 24 hours (higher scores indicate higher itch severity). The endpoint is the average of daily assessments reported during each study week, and requires at least 4 daily assessments reported during the week. In participants with a weekly average baseline pruritus score of ≥4, success is defined as achievement of a ≥4-point improvement from baseline in weekly average WI-NRS pruritus score at Week 4.
Time frame: Week 4
Population: All randomized participants with a weekly baseline average WI-NRS score ≥4 are included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Roflumilast Foam 0.3% | Achievement of Success in the WI-NRS at Week 4 | 48 percentage of participants |
| Vehicle Foam | Achievement of Success in the WI-NRS at Week 4 | 29 percentage of participants |
Comparison: WI-NRS Success at Week 4p-value: 0.000795% CI: [1.47, 4.67]Cochran-Mantel-Haenszel
Secondary
Achievement of Success in the Worst Itch Numeric Rating Scale (WI-NRS) at Week 8
The percentage of participants achieving WI-NRS success is presented. The WI-NRS is a simple, single-item scale to assess the participant-reported severity of this symptom, on a scale ranging from 0 (no itch) to 10 (worst imaginable itch) the participants experienced in the previous 24 hours (higher scores indicate higher itch severity). The endpoint is the average of daily assessments reported during each study week, and requires at least 4 daily assessments reported during the week. In participants with a weekly average baseline pruritus score of ≥4, success is defined as achievement of a ≥4-point improvement from baseline in weekly average WI-NRS pruritus score at Week 8.
Time frame: Week 8
Population: All randomized participants with a weekly baseline average WI-NRS score ≥4 are included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Roflumilast Foam 0.3% | Achievement of Success in the Worst Itch Numeric Rating Scale (WI-NRS) at Week 8 | 63 percentage of participants |
| Vehicle Foam | Achievement of Success in the Worst Itch Numeric Rating Scale (WI-NRS) at Week 8 | 41 percentage of participants |
Comparison: WI-NRS Success at Week 8p-value: 0.000195% CI: [1.68, 5.19]Cochran-Mantel-Haenszel
Secondary
Achievement of Success on the IGA at Week 2
The percentage of participants achieving WI-NRS success is presented. The WI-NRS is a simple, single-item scale to assess the participant-reported severity of this symptom, on a scale ranging from 0 (no itch) to 10 (worst imaginable itch) the participants experienced in the previous 24 hours (higher scores indicate higher itch severity). The endpoint is the average of daily assessments reported during each study week, and requires at least 4 daily assessments reported during the week. In participants with a weekly average baseline pruritus score of ≥4, success is defined as achievement of a ≥4-point improvement from baseline in weekly average WI-NRS pruritus score at Week 2.
Time frame: Week 2
Population: All randomized participants are included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Roflumilast Foam 0.3% | Achievement of Success on the IGA at Week 2 | 43 percentage of participants |
| Vehicle Foam | Achievement of Success on the IGA at Week 2 | 26 percentage of participants |
Comparison: IGA Success at Week 2p-value: 0.000295% CI: [1.54, 3.84]Cochran-Mantel-Haenszel
Secondary
Achievement of Success on the IGA at Week 4
The percentage of participants achieving IGA success is presented. Success is defined as a score of 0 ('clear') or 1 ('almost clear') plus a 2-point improvement at Week 8. The IGA is 5-point scale assessing the severity of seborrheic dermatitis with total scores ranging from 0 ('clear') to 4 ('severe') \[higher scores indicating greater severity\].
Time frame: Week 4
Population: All randomized participants are included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Roflumilast Foam 0.3% | Achievement of Success on the IGA at Week 4 | 73.1 percentage of participants |
| Vehicle Foam | Achievement of Success on the IGA at Week 4 | 47.1 percentage of participants |
Comparison: IGA Success at Week 4p-value: <0.000195% CI: [2.06, 5.03]Cochran-Mantel-Haenszel