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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Roflumilast Foam 0.3% | Experimental | Participants with seborrheic dermatitis apply roflumilast foam 0.3% once daily (QD) for 8 weeks. |
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| Vehicle Foam | Placebo Comparator | Participants with seborrheic dermatitis apply vehicle foam QD for 8 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Roflumilast Foam | Drug | Roflumilast 0.3% foam for topical application |
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| Measure | Description | Time Frame |
|---|---|---|
| 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]. | Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Berk, MD | Arcutis Biotherapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arcutis Biotherapeutics Clinical Site 01 | Scottsdale | Arizona | 85255 | United States | ||
| Arcutis Biotherapeutics Clinical Site 45 |
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Participants were enrolled at 50 study centers in the US and Canada.
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| ID | Title | Description |
|---|---|---|
| FG000 | Roflumilast Foam 0.3% | Participants with seborrheic dermatitis applied roflumilast foam 0.3% once daily (QD) for 8 weeks. |
| FG001 | Vehicle Foam | Participants with seborrheic dermatitis applied vehicle foam QD for 8 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 5, 2022 | Jan 4, 2024 |
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| Vehicle Foam | Drug | Vehicle foam for topical application |
|
| 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. | 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). | 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. | 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]. | 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. | 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. | Week 8 |
| Encinitas |
| California |
| 92024 |
| United States |
| Arcutis Biotherapeutics Clinical Site 46 | San Diego | California | 92123 | United States |
| Arcutis Biotherapeutics Clinical Site 64 | San Diego | California | 92123 | United States |
| Arcutis Biotherapeutics Clinical Site 21 | Santa Monica | California | 90404 | United States |
| Arcutis Biotherapeutics Clinical Site 42 | Coral Gables | Florida | 33134 | United States |
| Arcutis Biotherapeutics Clinical Site 57 | Delray Beach | Florida | 33484 | United States |
| Arcutis Biotherapeutics Clinical Site 33 | Largo | Florida | 33770 | United States |
| Arcutis Biotherapeutics Clinical Site 31 | North Miami Beach | Florida | 33162 | United States |
| Arcutis Biotherapeutics Clinical Site 65 | Sanford | Florida | 32771 | United States |
| Arcutis Biotherapeutics Clinical Site 12 | Tampa | Florida | 33613 | United States |
| Arcutis Biotherapeutics Clinical Site 10 | Rolling Meadows | Illinois | 60008 | United States |
| Arcutis Biotherapeutics Clinical Site 03 | Indianapolis | Indiana | 46250 | United States |
| Arcutis Biotherapeutics Clinical Site 22 | Plainfield | Indiana | 46168 | United States |
| Arcutis Biotherapeutics Clinical Site 15 | Louisville | Kentucky | 40217 | United States |
| Arcutis Biotherapeutics Clinical Site 04 | Lake Charles | Louisiana | 70605 | United States |
| Arcutis Biotherapeutics Clinical Site 02 | Rockville | Maryland | 20850 | United States |
| Arcutis Biotherapeutics Clinical Site 28 | Rockville | Maryland | 20850 | United States |
| Arcutis Biotherapeutics Clinical Site 40 | Clinton Township | Michigan | 48038 | United States |
| Arcutis Biotherapeutics Clinical Site 20 | Detroit | Michigan | 48202 | United States |
| Arcutis Biotherapeutics Clinical Site 14 | Fridley | Minnesota | 55432 | United States |
| Arcutis Biotherapeutics Clinical Site 44 | Saint Joseph | Missouri | 64506 | United States |
| Arcutis Biotherapeutics Clinical Site 19 | Reno | Nevada | 89509 | United States |
| Arcutis Biotherapeutics Clinical Site 34 | East Windsor | New Jersey | 08520 | United States |
| Arcutis Biotherapeutics Clinical Site 66 | New York | New York | 10065 | United States |
| Arcutis Biotherapeutics Clinical Site 63 | The Bronx | New York | 10462 | United States |
| Arcutis Biotherapeutics Clinical Site 23 | High Point | North Carolina | 27262 | United States |
| Arcutis Biotherapeutics Clinical Site 70 | Winston-Salem | North Carolina | 27104 | United States |
| Arcutis Biotherapeutics Clinical Site 18 | Bexley | Ohio | 43209 | United States |
| Arcutis Biotherapeutics Clinical Site 71 | Portland | Oregon | 97223 | United States |
| Arcutis Biotherapeutics Clinical Site 08 | Broomall | Pennsylvania | 19008 | United States |
| Arcutis Biotherapeutics Clinical Site 27 | Pittsburgh | Pennsylvania | 15213 | United States |
| Arcutis Biotherapeutics Clinical Site 06 | Knoxville | Tennessee | 37922 | United States |
| Arcutis Biotherapeutics Clinical Site 13 | Arlington | Texas | 76011 | United States |
| Arcutis Biotherapeutics Clinical Site 11 | Austin | Texas | 78759 | United States |
| Arcutis Biotherapeutics Clinical Site 41 | College Station | Texas | 77845 | United States |
| Arcutis Biotherapeutics Clinical Site 60 | Houston | Texas | 77030 | United States |
| Arcutis Biotherapeutics Clinical Site 26 | Pflugerville | Texas | 78660 | United States |
| Arcutis Biotherapeutics Clinical Site 72 | Plano | Texas | 75024 | United States |
| Arcutis Biotherapeutics Clinical Site 54 | San Antonio | Texas | 78213 | United States |
| Arcutis Biotherapeutics Clinical Site 24 | San Antonio | Texas | 78218 | United States |
| Arcutis Biotherapeutics Clinical Site 07 | West Jordan | Utah | 84088 | United States |
| Arcutis Biotherapeutics Clinical Site 17 | Norfolk | Virginia | 23502 | United States |
| Arcutis Biotherapeutics Clinical Site 35 | Calgary | Alberta | T2J 7E1 | Canada |
| Arcutis Biotherapeutics Clinical Site 37 | Surrey | British Columbia | V3V 0C6 | Canada |
| Arcutis Biotherapeutics Clinical Site 47 | Winnipeg | Manitoba | R3M 3Z4 | Canada |
| Arcutis Biotherapeutics Clinical Site 43 | Fredericton | New Brunswick | E3B 1G9 | Canada |
| Arcutis Biotherapeutics Clinical Site 16 | London | Ontario | N6H 5L5 | Canada |
| Arcutis Biotherapeutics Clinical Site 29 | Mississauga | Ontario | L5H 1G9 | Canada |
| Arcutis Biotherapeutics Clinical Site 30 | North Bay | Ontario | P1B 3Z7 | Canada |
| Arcutis Biotherapeutics Clinical Site 32 | Peterborough | Ontario | K9J 5K2 | Canada |
| Arcutis Biotherapeutics Clinical Site 36 | Waterloo | Ontario | N2J 1C4 | Canada |
| Arcutis Biotherapeutics Clinical Site 09 | Westmount | Quebec | H3Z 2S6 | Canada |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Roflumilast Foam 0.3% | Participants with seborrheic dermatitis applied roflumilast foam 0.3% once daily (QD) for 8 weeks. |
| BG001 | Vehicle Foam | Participants with seborrheic dermatitis applied vehicle foam QD for 8 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Investigator Global Assessment (IGA) Baseline Score | 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]. | Count of Participants | Participants |
| |||||||||||||||
| Worst Itch Numerical Rating Scale (WI-NRS) Baseline Score | 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). | Some participants did not have a baseline WI-NRS assessment. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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]. | All randomized participants are included. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 8 |
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| 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. | All randomized participants with a weekly baseline average WI-NRS score ≥4 are included. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 8 |
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| 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. | All randomized participants with a weekly baseline average WI-NRS score ≥4 are included. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 4 |
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| 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). | All randomized participants with a weekly baseline average WI-NRS score ≥4 are included. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 2 |
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| 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. | All randomized participants are included. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 2 |
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| 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]. | All randomized participants are included. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 4 |
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| 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. | All randomized participants are included. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 8 |
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| 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. | All randomized participants are included. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 8 |
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Up to ~8 weeks
All randomized participants are included.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Roflumilast Foam 0.3% | Participants with seborrheic dermatitis applied roflumilast foam 0.3% once daily (QD) for 8 weeks. | 0 | 304 | 1 | 304 | 0 | 304 |
| EG001 | Vehicle Foam | Participants with seborrheic dermatitis applied vehicle foam QD for 8 weeks. | 0 | 153 | 0 | 153 | 0 | 153 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Keratoacanthoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (24.1) | Systematic Assessment |
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The Sponsor is supportive of publishing clinical trial findings. The process of coordinating publication efforts is detailed in the Clinical Trial Agreement.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Arcutis Medical Information | Arcutis Biotherapeutics | +1 (844) 692-6729 | medinfo@arcutis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 22, 2022 | Jan 4, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D012628 | Dermatitis, Seborrheic |
| ID | Term |
|---|---|
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
| D017443 | Skin Diseases, Eczematous |
| D017444 | Skin Diseases, Papulosquamous |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Other |
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| 3 - Moderate |
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| 4 - Severe |
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| 1 |
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| 2 |
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| 3 |
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| 4 |
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| 5 |
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| 6 |
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| 7 |
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| 8 |
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| 9 |
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| 10 |
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| Participants |
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