A Phase 3 interventional study of Roflumilast Foam and Vehicle Foam in Seborrheic Dermatitis, sponsored by Arcutis Biotherapeutics, Inc.. Completed at 53 sites in 2 countries. Open to participants aged 9 Years and older. Per ClinicalTrials.gov, last updated 2024-03-12.
Sponsored by Arcutis Biotherapeutics, Inc. · Phase 3, Interventional, and Treatment
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.
1,435 studies on the registry are indexed under Dermatitis; 131 are open to participants now.
This study's enrollment of 457 is above the median of 64 across 1,131 interventional studies indexed under Dermatitis.
Browse Dermatitis studies →Arcutis Biotherapeutics, Inc. is the lead sponsor of 24 studies on the registry; 1 is open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 19 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Participants with seborrheic dermatitis apply roflumilast foam 0.3% once daily (QD) for 8 weeks.
Drug: Roflumilast Foam
Participants with seborrheic dermatitis apply vehicle foam QD for 8 weeks.
Drug: Vehicle Foam
Roflumilast 0.3% foam for topical application
Also known as: ARQ-154
Vehicle foam for topical application
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
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
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
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
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
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
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
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
| Milestone | Roflumilast Foam 0.3% | Vehicle Foam |
|---|---|---|
| Started | 304 | 153 |
| Completed | 276 | 138 |
| Not completed | 28 | 15 |
| Withdrew: Adverse event | 2 | 3 |
| Withdrew: Lack of efficacy | 1 | 3 |
| Withdrew: Lost to follow-up | 12 | 4 |
| Withdrew: Withdrawal by subject | 11 | 4 |
| Withdrew: Did not tolerate application | 1 | 0 |
| Withdrew: Wanted to early terminate and use own product | 0 | 1 |
| Withdrew: Missed visits due to new work schedule | 1 | 0 |
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') \[higher scores indicating greater severity\].
| percentage of participants | Roflumilast Foam 0.3% | Vehicle Foam |
|---|---|---|
| Achievement of Success on the Investigator Global Assessment (IGA) at Week 8 | 80 (74 to 84) | 58 (50 to 66) |
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.
| percentage of participants | Roflumilast Foam 0.3% | Vehicle Foam |
|---|---|---|
| Achievement of Success in the Worst Itch Numeric Rating Scale (WI-NRS) at Week 8 | 63 (56 to 70) | 41 (31 to 51) |
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.
| percentage of participants | Roflumilast Foam 0.3% | Vehicle Foam |
|---|---|---|
| Achievement of Success in the WI-NRS at Week 4 | 48 (41 to 54) | 29 (21 to 39) |
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).
| percentage of participants | Roflumilast Foam 0.3% | Vehicle Foam |
|---|---|---|
| Achievement of Success in the WI-NRS at Week 2 | 33 (27 to 40) | 16 (10 to 24) |
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.
| percentage of participants | Roflumilast Foam 0.3% | Vehicle Foam |
|---|---|---|
| Achievement of Success on the IGA at Week 2 | 43 (37 to 49) | 26 (19 to 33) |
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') \[higher scores indicating greater severity\].
| percentage of participants | Roflumilast Foam 0.3% | Vehicle Foam |
|---|---|---|
| Achievement of Success on the IGA at Week 4 | 73.1 (67.67 to 77.83) | 47.1 (39.19 to 55.10) |
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.
| percentage of participants | Roflumilast Foam 0.3% | Vehicle Foam |
|---|---|---|
| Achievement of Overall Assessment of Scaling Score of 0 at Week 8 | 58 (52 to 63) | 37 (29 to 45) |
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.
| percentage of participants | Roflumilast Foam 0.3% | Vehicle Foam |
|---|---|---|
| Achievement of Overall Assessment of Erythema Score of 0 at Week 8 | 58 (52 to 63) | 32 (25 to 40) |
Collected over Up to ~8 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Roflumilast Foam 0.3% | 0/304 (0%) | 1/304 (0.3%) | 0/304 (0%) |
| Vehicle Foam | 0/153 (0%) | 0/153 (0%) | 0/153 (0%) |
| Event | Roflumilast Foam 0.3% | Vehicle Foam |
|---|---|---|
| KeratoacanthomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/304 | 0/153 |
| Age, Continuous(years) | Roflumilast Foam 0.3% | Vehicle Foam | Total |
|---|---|---|---|
| Mean | 43.2 ± 16.81 | 41.8 ± 17.47 | 42.7 ± 17.03 |
| Sex: Female, Male(Participants) | Roflumilast Foam 0.3% | Vehicle Foam | Total |
|---|---|---|---|
| Female | 151 | 78 | 229 |
| Male | 153 | 75 | 228 |
| Ethnicity (NIH/OMB)(Participants) | Roflumilast Foam 0.3% | Vehicle Foam | Total |
|---|---|---|---|
| Hispanic or Latino | 69 | 28 | 97 |
| Not Hispanic or Latino | 235 | 125 | 360 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Roflumilast Foam 0.3% | Vehicle Foam | Total |
|---|---|---|---|
| American Indian or Alaska Native | 4 | 0 | 4 |
| Asian | 18 | 10 | 28 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Black or African American | 36 | 15 | 51 |
| White | 234 | 122 | 356 |
| More than one race | 1 | 1 | 2 |
| Other | 11 | 4 | 15 |
| Investigator Global Assessment (IGA) Baseline Score(Participants) | Roflumilast Foam 0.3% | Vehicle Foam | Total |
|---|---|---|---|
| 2 - Mild | 0 | 0 | 0 |
| 3 - Moderate | 287 | 141 | 428 |
| 4 - Severe | 17 | 12 | 29 |
| Worst Itch Numerical Rating Scale (WI-NRS) Baseline Score(Participants) | Roflumilast Foam 0.3% | Vehicle Foam | Total |
|---|---|---|---|
| 0 | 20 | 9 | 29 |
| 1 | 13 | 14 | 27 |
| 2 | 22 | 10 | 32 |
| 3 | 35 | 16 | 51 |
| 4 | 26 | 15 | 41 |
| 5 | 43 | 20 | 63 |
| 6 | 40 | 22 | 62 |
| 7 | 39 | 17 | 56 |
| 8 | 33 | 16 | 49 |
| 9 | 14 | 7 | 21 |
| 10 | 12 | 6 | 18 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Arcutis Biotherapeutics, Inc.