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This study was a Phase 3, multicenter, open-label extension study of the long-term safety of roflumilast cream 0.15% (completers of studies ARQ-151-311 or ARQ-151-312 aged ≥6 years and ARQ-151-315 rollovers who turned 6 years of age on study) or roflumilast cream 0.05% (ARQ-151-315 rollovers aged 2 to 5 years). Participants with mild to moderate atopic dermatitis (AD) applied roflumilast cream once daily (qd) for up to 52 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARQ-151 Cream 0.05% | Experimental | Participants applied ARQ-151 Cream 0.05% once daily (qd) for up to 52 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARQ-151 Cream 0.15% or ARQ-151 Cream 0.05% | Drug | ARQ-151 Cream 0.15% or ARQ-151 Cream 0.05% |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With ≥1 Treatment-emergent Adverse Event (TEAE) | The number of participants with ≥1 TEAE(s) is reported. | Up to 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Validated Investigator Global Assessment-Atopic Dermatitis (vIGA-AD) Score of 0 or 1 at Each Assessment | The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (reported as score of 0 'clear' to 4 'severe' ), with lower scores indicating reduced symptom severity and vice versa. Multiple imputation was used to handle missing data up to Week 24 or 52 for 24- and 52-week cohorts. |
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Inclusion Criteria:
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 Clinical Site 112 | Birmingham | Alabama | 35209 | United States | ||
| Arcutis Clinical Site 73 |
Participants with atopic dermatitis were enrolled at 153 sites in the United States (US), Canada, and Poland.
Participants were rolled over upon completion of parent studies ARQ-151-311 (NCT04773587), ARQ-151-312 (NCT03638258), and ARQ-151-315 (NCT04845620). Rollovers from 311/312 were analyzed separately from 315 rollovers.
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| ID | Title | Description |
|---|---|---|
| FG000 | ARQ-151-311/312: RC/RC 0.15% Group | Participants who received roflumilast cream 0.15% in parent studies received roflumilast 0.15% cream qd for up to 52 weeks in the present study. |
| FG001 | ARQ-151-311/312: VC/RC 0.15% Group |
| 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 | Sep 17, 2021 | Nov 3, 2025 |
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| Weeks 4, 12, 24, 36, and 52 |
| Percentage of Participants With vIGA-AD Success | The percentage of participants with vIGA-AD "success" is presented. Success is defined as vIGA-AD value of 0 or 1 plus a 2-grade improvement from baseline. Multiple imputation was used to handle missing data up to Week 24 or 52 for 24- and 52-week cohorts. | Weeks 4, 12, 24, 36, and 52 |
| Change From Baseline in Worst Itch-Numeric Rating Scale (WI-NRS) Score Over Time in Participants ≥12 Years of Age in Parent Study | Change from baseline in WI-NRS score is reported. WI-NRS is a subject-reported severity of itch at its highest intensity during the previous 24-hour period. The scale is from '0 to 10' ("no itch" to "worst imaginable itch"), with lower scores indicating reduced symptom severity and vice versa. | Weeks 4, 12, 24, 36, and 52 |
| Percent Change From Baseline in EASI Score | EASI is an instrument to measure the severity and extent of AD. The body is first divided into 4 areas: head (10% of skin), arms (20%), trunk (30%), and legs (40%). Then, the area affected is scored from 0 (0% involvement) to 6 (90%-100% involvement), and severity is scored from 0 ('none') to 3 ('severe'). EASI combines the area affected and severity ratings to get a final composite score ranging from 0 (no disease) to 72 (severe disease). Note that palms and soles were treated as appropriate but were not counted towards any measurements of EASI. | Weeks 4, 12, 24, 36, and 52 |
| Birmingham |
| Alabama |
| 35244 |
| United States |
| Arcutis Clinical Site 63 | Scottsdale | Arizona | 85255 | United States |
| Arcutis Clinical Site 106 | Bryant | Arkansas | 72022 | United States |
| Arcutis Clinical Site 116 | Fort Smith | Arkansas | 72916 | United States |
| Arcutis Clinical Site 69 | Beverly Hills | California | 90212 | United States |
| Arcutis Clinical Site 81 | Inglewood | California | 90301 | United States |
| Clinical Site 08 | San Francisco | California | 94132 | United States |
| Arcutis Clinical Site 31 | Santa Monica | California | 90404 | United States |
| Arcutis Clinical Site 130 | Thousand Oaks | California | 91320 | United States |
| Arcutis Clinical Site 123 | Centennial | Colorado | 80112 | United States |
| Arcutis Clinical Site 59 | Coral Gables | Florida | 33134 | United States |
| Arcutis Clinical Site 72 | Coral Gables | Florida | 33146 | United States |
| Arcutis Clinical Site 79 | Delray Beach | Florida | 33484 | United States |
| Arcutis Clinical Site 103 | Hollywood | Florida | 33021 | United States |
| Clinical Site 04 | Jacksonville | Florida | 32256 | United States |
| Arcutis Clinical Site 15 | Largo | Florida | 33770 | United States |
| Arcutis Clinical Site 67 | Miami | Florida | 33162 | United States |
| Arcutis Clinical Site 95 | Miami | Florida | 33173 | United States |
| Arcutis Clinical Site 68 | Miami | Florida | 33174 | United States |
| Arcutis Clinical Site 29 | Sanford | Florida | 32771 | United States |
| Clinical Site 01 | Tampa | Florida | 33613 | United States |
| Arcutis Clinical Site 138 | Wellington | Florida | 33449 | United States |
| Arcutis Clinical Site 47 | Sandy Springs | Georgia | 30328 | United States |
| Arcutis Clinical Site 145 | Boise | Idaho | 83706 | United States |
| Arcutis Clinical Site 13 | Rolling Meadows | Illinois | 33770 | United States |
| Arcutis Clinical Site 93 | Clarksville | Indiana | 47129 | United States |
| Clinical Site 22 | Plainfield | Indiana | 46168 | United States |
| Arcutis Clinical Site 114 | West Lafayette | Indiana | 47906 | United States |
| Clinical Site 03 | Louisville | Kentucky | 40217 | United States |
| Arcutis Clinical Site 80 | Covington | Louisiana | 70433 | United States |
| Arcutis Clinical Site 85 | Lake Charles | Louisiana | 70605 | United States |
| Arcutis Clinical Site 24 | Metairie | Louisiana | 70006 | United States |
| Arcutis Clinical Site 76 | Rockville | Maryland | 20850 | United States |
| Arcutis Clinical Site 94 | Bay City | Michigan | 48706 | United States |
| Arcutis Clinical Site 88 | Clarkston | Michigan | 48346 | United States |
| Arcutis Clinical Site 58 | Clinton Township | Michigan | 48038 | United States |
| Arcutis Clinical Site 66 | Detroit | Michigan | 48202 | United States |
| Arcutis Clinical Site 132 | Troy | Michigan | 48084 | United States |
| Clinical Site 10 | New Brighton | Minnesota | 55112 | United States |
| Arcutis Clinical Site 102 | Saint Joseph | Missouri | 64506 | United States |
| Arcutis Clinical Site 62 | Reno | Nevada | 89509 | United States |
| Arcutis Clinical Site 71 | East Windsor | New Jersey | 08520 | United States |
| Arcutis Clinical Site 96 | Kew Gardens | New York | 11415 | United States |
| Arcutis Clinical Site 82 | Rochester | New York | 14623 | United States |
| Arcutis Clinical Site 19 | High Point | North Carolina | 27262 | United States |
| Arcutis Clinical Site 17 | Gresham | Oregon | 97030 | United States |
| Arcutis Clinical Site 108 | Portland | Oregon | 97210 | United States |
| Arcutis Clinical Site 16 | Portland | Oregon | 97223 | United States |
| Arcutis Clinical Site 14 | Portland | Oregon | 97239 | United States |
| Arcutis Clinical Site 53 | Hershey | Pennsylvania | 17033 | United States |
| Arcutis Clinical Site 64 | Newtown Square | Pennsylvania | 19073 | United States |
| Arcutis Clinical Site 25 | Pittsburgh | Pennsylvania | 15213 | United States |
| Arcutis Clinical Site 101 | Johnston | Rhode Island | 02919 | United States |
| Arcutis Clinical Site 77 | Charleston | South Carolina | 29407 | United States |
| Arcutis Clinical Site 41 | Charleston | South Carolina | 29425 | United States |
| Clinical Site 33 | North Charleston | South Carolina | 29420 | United States |
| Arcutis Clinical Site 91 | Summerville | South Carolina | 29486 | United States |
| Arcutis Clinical Site 60 | Murfreesboro | Tennessee | 37130 | United States |
| Arcutis Clinical Site 34 | Arlington | Texas | 76011 | United States |
| Clinical Site 23 | Austin | Texas | 78759 | United States |
| Arcutis Clinical Site 84 | Bellaire | Texas | 77401 | United States |
| Arcutis Clinical Site 21 | College Station | Texas | 77845 | United States |
| Arcutis Clinical Site 126 | Frisco | Texas | 75034 | United States |
| Arcutis Clinical Site 118 | Grapevine | Texas | 76051 | United States |
| Arcutis Clinical Site 48 | Houston | Texas | 77030 | United States |
| Arcutis Clinical Site 35 | Houston | Texas | 77056 | United States |
| Arcutis Clinical Site 109 | Katy | Texas | 77494 | United States |
| Clinical Site 20 | San Antonio | Texas | 78213 | United States |
| Arcutis Clinical Site 49 | San Antonio | Texas | 78218 | United States |
| Arcutis Clinical Site 74 | Orem | Utah | 84058 | United States |
| Arcutis Clinical Site 36 | West Jordan | Utah | 84088 | United States |
| Arcutis Clinical Site 51 | Burke | Virginia | 22015 | United States |
| Arcutis Clinical Site 40 | Norfolk | Virginia | 23502 | United States |
| Arcutis Clinical Site 12 | Spokane | Washington | 99202 | United States |
| Arcutis Clinical Site 133 | Kenosha | Wisconsin | 53142 | United States |
| Arcutis Clinical Site 70 | Calgary | Alberta | T2J 7E1 | Canada |
| Arcutis Clinical Site 27 | Surrey | British Columbia | V3R 6A7 | Canada |
| Arcutis Clinical Site 55 | Winnipeg | Manitoba | R3M 3Z4 | Canada |
| Arcutis Clinical Site 50 | Fredericton | New Brunswick | E3B 1G9 | Canada |
| Arcutis Clinical Site 43 | Ajax | Ontario | L1S 7K8 | Canada |
| Arcutis Clinical Site 52 | London | Ontario | N6H 5L5 | Canada |
| Clinical Site 11 | Markham | Ontario | L3P 1X3 | Canada |
| Clinical Site 46 | Mississauga | Ontario | L5H 1G9 | Canada |
| Arcutis Clinical Site 46 | Montréal | Ontario | H2X 2V1 | Canada |
| Arcutis Clinical Site 61 | Peterborough | Ontario | K9J 5K2 | Canada |
| Arcutis Clinical Site 54 | Toronto | Ontario | M4W 2N4 | Canada |
| Arcutis Clinical Site 39 | Waterloo | Ontario | N2J 1C4 | Canada |
| Clinical Site 09 | Windsor | Ontario | N8W 1E6 | Canada |
| Arcutis Clinical Site 26 | Drummondville | Quebec | J2B 5L4 | Canada |
| Arcutis Clinical Site 45 | Montreal | Quebec | H2X 2V1 | Canada |
| Arcutis Clinical Site 56 | Montreal | Quebec | H3Z 2S6 | Canada |
Participants who received vehicle cream in the parent studies received roflumilast 0.15% cream qd for up to 52 weeks in the present study.
| FG002 | ARQ-151-315: RC/RC 0.05% or 0.15% Group | Participants who received roflumilast cream 0.05% or 0.15% in the parent study received roflumilast 0.15% cream qd for up to 52 weeks in the present study. Participants received 0.05% until the first study visit after turning 6 years of age, and were then switched to 0.15%. |
| FG003 | ARQ-151-315: VC/RC 0.05% or 0.15% Group | Participants who received vehicle cream in the parent study received roflumilast 0.05% or 0.15% cream qd for up to 52 weeks in the present study. Participants received 0.05% until the first study visit after turning 6 years of age, and were then switched to 0.15%. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
One participant discontinued from the VC/RC Group prior to dosing.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | ARQ-151-311/312: RC/RC 0.15% Group | Participants who received roflumilast cream 0.15% in parent studies received roflumilast 0.15% cream qd for up to 52 weeks in the present study. |
| BG001 | ARQ-151-311/312: VC/RC 0.15% Group | Participants who received vehicle cream in the parent studies received roflumilast 0.15% cream qd for up to 52 weeks in the present study. |
| BG002 | ARQ-151-315: RC/RC 0.05% or 0.15% Group | Participants who received roflumilast cream 0.05% or 0.15% in the parent study received roflumilast 0.15% cream qd for up to 52 weeks in the present study. Participants received 0.05% until the first study visit after turning 6 years of age, and were then switched to 0.15%. |
| BG003 | ARQ-151-315: VC/RC 0.05% or 0.15% Group | Participants who received vehicle cream in the parent study received roflumilast 0.05% or 0.15% cream qd for up to 52 weeks in the present study. Participants received 0.05% until the first study visit after turning 6 years of age, and were then switched to 0.15%. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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 | Number of Participants With ≥1 Treatment-emergent Adverse Event (TEAE) | The number of participants with ≥1 TEAE(s) is reported. | All treated participants are included. | Posted | Count of Participants | Participants | Up to 52 weeks |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Validated Investigator Global Assessment-Atopic Dermatitis (vIGA-AD) Score of 0 or 1 at Each Assessment | The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (reported as score of 0 'clear' to 4 'severe' ), with lower scores indicating reduced symptom severity and vice versa. Multiple imputation was used to handle missing data up to Week 24 or 52 for 24- and 52-week cohorts. | All randomized participants are included. | Posted | Number | 95% Confidence Interval | percentage of participants | Weeks 4, 12, 24, 36, and 52 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With vIGA-AD Success | The percentage of participants with vIGA-AD "success" is presented. Success is defined as vIGA-AD value of 0 or 1 plus a 2-grade improvement from baseline. Multiple imputation was used to handle missing data up to Week 24 or 52 for 24- and 52-week cohorts. | All randomized participants are included. | Posted | Number | 95% Confidence Interval | percentage of participants | Weeks 4, 12, 24, 36, and 52 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Worst Itch-Numeric Rating Scale (WI-NRS) Score Over Time in Participants ≥12 Years of Age in Parent Study | Change from baseline in WI-NRS score is reported. WI-NRS is a subject-reported severity of itch at its highest intensity during the previous 24-hour period. The scale is from '0 to 10' ("no itch" to "worst imaginable itch"), with lower scores indicating reduced symptom severity and vice versa. | All randomized participants who were ≥12 years of age at the start of the parent studies are included. | Posted | Mean | Standard Deviation | WI-NRS Score Change | Weeks 4, 12, 24, 36, and 52 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in EASI Score | EASI is an instrument to measure the severity and extent of AD. The body is first divided into 4 areas: head (10% of skin), arms (20%), trunk (30%), and legs (40%). Then, the area affected is scored from 0 (0% involvement) to 6 (90%-100% involvement), and severity is scored from 0 ('none') to 3 ('severe'). EASI combines the area affected and severity ratings to get a final composite score ranging from 0 (no disease) to 72 (severe disease). Note that palms and soles were treated as appropriate but were not counted towards any measurements of EASI. | All randomized participants with data available are included. | Posted | Mean | Standard Deviation | Percent change in EASI score | Weeks 4, 12, 24, 36, and 52 |
|
Up to 52 weeks
All treated participants are included.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ARQ-151-311/312: RC/RC 0.15% Group | Participants who received roflumilast cream 0.15% in parent studies received roflumilast 0.15% cream qd for up to 52 weeks in the present study. | 0 | 439 | 5 | 439 | 18 | 439 |
| EG001 | ARQ-151-311/312: VC/RC 0.15% Group | Participants who received vehicle cream in the parent studies received roflumilast 0.15% cream qd for up to 52 weeks in the present study. | 0 | 218 | 3 | 218 | 12 | 218 |
| EG002 | ARQ-151-315: RC/RC 0.05% or 0.15% Group | Participants who received roflumilast cream 0.05% or 0.15% in the parent study received roflumilast 0.15% cream qd for up to 52 weeks in the present study. Participants received 0.05% until the first study visit after turning 6 years of age, and were then switched to 0.15%. | 0 | 382 | 12 | 382 | 82 | 382 |
| EG003 | ARQ-151-315: VC/RC 0.05% or 0.15% Group | Participants who received vehicle cream in the parent study received roflumilast 0.05% or 0.15% cream qd for up to 52 weeks in the present study. Participants received 0.05% until the first study visit after turning 6 years of age, and were then switched to 0.15%. | 0 | 180 | 3 | 180 | 40 | 180 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Aortic aneurysm | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Anaphylactic shock | Immune system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Abscess jaw | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Application site cellulitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Eczema infected | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Gastrointestinal bacterial overgrowth | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Skin bacterial infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Penetrating abdominal trauma | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Bronchial hyperreactivity | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
The process of coordinating publication efforts is described 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 | Dec 20, 2022 | Nov 3, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| C424423 | Roflumilast |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG003 | ARQ-151-315: VC/RC 0.05% or 0.15% Group | Participants who received vehicle cream in the parent study received roflumilast 0.05% or 0.15% cream qd for up to 52 weeks in the present study. Participants received 0.05% until the first study visit after turning 6 years of age, and were then switched to 0.15%. |
|
|
| OG003 | ARQ-151-315: VC/RC 0.05% or 0.15% Group | Participants who received vehicle cream in the parent study received roflumilast 0.05% or 0.15% cream qd for up to 52 weeks in the present study. Participants received 0.05% until the first study visit after turning 6 years of age, and were then switched to 0.15%. |
|
|
| OG003 | ARQ-151-315: VC/RC 0.05% or 0.15% Group | Participants who received vehicle cream in the parent study received roflumilast 0.05% or 0.15% cream qd for up to 52 weeks in the present study. Participants received 0.05% until the first study visit after turning 6 years of age, and were then switched to 0.15%. |
|
|
| OG003 | ARQ-151-315: VC/RC 0.05% or 0.15% Group | Participants who received vehicle cream in the parent study received roflumilast 0.05% or 0.15% cream qd for up to 52 weeks in the present study. Participants received 0.05% until the first study visit after turning 6 years of age, and were then switched to 0.15%. |
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