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This study will assess the safety and efficacy of ARQ-151 cream vs vehicle applied once a day for 4 weeks by subjects with atopic dermatitis (eczema). This is a parallel group, double blind, vehicle-controlled study in which ARQ-151 0.15% cream or vehicle is applied once daily (qd) for 4 weeks by participants with atopic dermatitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Roflumilast Cream 0.15% | Experimental | Participants apply roflumilast cream 0.15% once daily (qd) for 4 weeks. |
|
| Vehicle Cream | Placebo Comparator | Participants apply vehicle cream qd for 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Roflumilast Cream | Drug | Roflumilast cream 0.15% for topical application |
|
| Measure | Description | Time Frame |
|---|---|---|
| Achievement of Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) Success at Week 4 | The percentage of participants achieving viGA-AD "success" is presented with multiple imputation of missing observations. viGA-AD "success" is defined as a viGA-AD score of 'clear' or 'almost clear' PLUS a 2-grade improvement from Baseline. 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 only in integers of 0 to 4 where 0 is clear), with higher scores indicative of greater symptom severity. | Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Achievement of vIGA-AD Success at Week 4 in Participants With "Moderate" Baseline Scores | The percentage of participants with moderate baseline scores achieving viGA-AD "success" is presented with multiple imputation of missing observations. viGA-AD "success" is defined as a viGA-AD score of 'clear' or 'almost clear' PLUS a 2-grade improvement from baseline in participants with a 'moderate' baseline viGA-AD score. The viGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (0 'clear' to 4 'severe'), with higher scores indicative of greater symptom severity. |
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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 31 | Birmingham | Alabama | 35244 | United States | ||
| Arcutis Clinical Site 51 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39292443 | Derived | Simpson EL, Eichenfield LF, Alonso-Llamazares J, Draelos ZD, Ferris LK, Forman SB, Gooderham M, Gonzalez ME, Hebert AA, Kircik LH, Lomaga M, Moore A, Papp KA, Prajapati VH, Hanna D, Snyder S, Krupa D, Burnett P, Almaraz E, Higham RC, Chu DH, Berk DR. Roflumilast Cream, 0.15%, for Atopic Dermatitis in Adults and Children: INTEGUMENT-1 and INTEGUMENT-2 Randomized Clinical Trials. JAMA Dermatol. 2024 Nov 1;160(11):1161-1170. doi: 10.1001/jamadermatol.2024.3121. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Roflumilast Cream 0.15% | Participants applied roflumilast cream 0.15% qd for 4 weeks. |
| FG001 | Vehicle Cream | Participants applied vehicle cream qd for 4 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 | Nov 4, 2020 | Aug 6, 2024 |
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| Vehicle cream | Drug | Vehicle cream for topical application |
|
| Week 4 |
| vIGA-AD Success at Week 2 | The percentage of participants achieving viGA-AD "success" is presented with multiple imputation of missing observations. viGA-AD "success" is defined as a viGA-AD score of 'clear' or 'almost clear' PLUS a 2-grade improvement from Baseline. 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 only in integers of 0 to 4 where 0 is clear), with higher scores indicative of greater symptom severity. | Week 2 |
| vIGA-AD Success at Week 1 | The percentage of participants achieving viGA-AD "success" is presented with multiple imputation of missing observations. viGA-AD "success" is defined as a viGA-AD score of 'clear' or 'almost clear' PLUS a 2-grade improvement from Baseline. 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 only in integers of 0 to 4 where 0 is clear), with higher scores indicative of greater symptom severity. | Week 1 |
| Achievement of a 4-point Reduction at Week 4 in the Average, Weekly Worst Itch Numeric Rating Scale (WI-NRS) in Participants With Baseline WI-NRS Score ≥4 | The percentage of participants with a baseline WI-NRS ≥ 4 achieving WI-NRS success is presented with multiple imputation of missing observations. 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 participant experienced in the previous 24 hours (higher scores indicate higher itch severity). | Week 4 |
| Achievement of a 4-point Reduction at Week 2 in the WI-NRS in Participants With Baseline WI-NRS Score ≥4 | The percentage of participants with a baseline WI-NRS ≥ 4 achieving WI-NRS success is presented with multiple imputation of missing observations. 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 participant experienced in the previous 24 hours (higher scores indicate higher itch severity). | Week 2 |
| Achievement of a 4-point Reduction at Week 1 in the WI-NRS in Participants With Baseline WI-NRS Score ≥4 | The percentage of participants with a baseline WI-NRS ≥ 4 achieving WI-NRS success is presented with multiple imputation of missing observations. 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 participant experienced in the previous 24 hours (higher scores indicate higher itch severity). | Week 1 |
| Achievement of ≥75% Decrease From Baseline at Week 4 in the Eczema Area and Severity Index (EASI-75) | The percentage of participants achieving EASI-75 is presented with multiple imputation of missing observations. EASI-75 is a ~75% reduction from the baseline EASI score. EASI combines the assessment of the severity of lesions and the area affected into a single total score in the range 0 (no disease) to 72 (maximal disease). To calculate the EASI, the sum = of the severity rating (0 to 3 with 3 being the most severe) for four clinical signs are multiplied with the numerical value of the area affected and with the percentage of the four body areas. | Week 4 |
| Achievement of vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 4 | The percentage of participants scoring 'clear' or 'almost clear' on viGA-AD is presented with multiple imputation of missing observations. The viGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (0 'clear' to 4 'severe'), with higher scores indicative of greater symptom severity. | Week 4 |
| Achievement of vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 2 | The percentage of participants scoring 'clear' or 'almost clear' on viGA-AD is presented with multiple imputation of missing observations. The viGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (0 'clear' to 4 'severe'), with higher scores indicative of greater symptom severity. | Week 2 |
| Achievement of vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 1 | The percentage of participants scoring 'clear' or 'almost clear' on viGA-AD is presented with multiple imputation of missing observations. The viGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (0 'clear' to 4 'severe'), with higher scores indicative of greater symptom severity. | Week 1 |
| Fort Smith |
| Arkansas |
| 72916 |
| United States |
| Arcutis Clinical Site 46 | Inglewood | California | 90301 | United States |
| Arcutis Clinical Site 19 | San Diego | California | 92123 | United States |
| Arcutis Clinical Site 36 | San Diego | California | 92123 | United States |
| Arcutis Clinical Site 13 | Santa Monica | California | 90404 | United States |
| Arcutis Clinical Site 54 | Centennial | Colorado | 80112 | United States |
| Arcutis Clinical Site 55 | Boca Raton | Florida | 33486 | United States |
| Arcutis Clinical Site 30 | Coral Gables | Florida | 33146 | United States |
| Arcutis Clinical Site 37 | Delray Beach | Florida | 33484 | United States |
| Arcutis Clinical Site 58 | Miami | Florida | 33137 | United States |
| Arcutis Clinical Site 41 | Miami | Florida | 33144 | United States |
| Arcutis Clinical Site 11 | Sanford | Florida | 32771 | United States |
| Arcutis Clinical Site 57 | West Palm Beach | Florida | 33406 | United States |
| Arcutis Clinical Site 62 | Boise | Idaho | 83706 | United States |
| Clinical Site 04 | Plainfield | Indiana | 46168 | United States |
| Arcutis Clinical Site 43 | Louisville | Kentucky | 40241 | United States |
| Arcutis Clinical Site 63 | Baton Rouge | Louisiana | 70808 | United States |
| Arcutis Clinical Site 42 | Lake Charles | Louisiana | 70605 | United States |
| Arcutis Clinical Site 38 | Mandeville | Louisiana | 70448 | United States |
| Arcutis Clinical Site 06 | Metairie | Louisiana | 70006 | United States |
| Arcutis Clinical Site 34 | Rockville | Maryland | 20850 | United States |
| Arcutis Clinical Site 29 | Clinton Township | Michigan | 48038 | United States |
| Arcutis Clinical Site 21 | Fort Gratiot | Michigan | 48059 | United States |
| Arcutis Clinical Site 61 | Troy | Michigan | 48084 | United States |
| Arcutis Clinical Site 245 | Saint Joseph | Missouri | 64506 | United States |
| Arcutis Clinical Site 53 | New York | New York | 11415 | United States |
| Arcutis Clinical Site 39 | Rochester | New York | 14623 | United States |
| Arcutis Clinical Site 33 | Stony Brook | New York | 11790 | United States |
| Arcutis Clinical Site 01 | High Point | North Carolina | 27262 | United States |
| Arcutis Clinical Site 24 | Hershey | Pennsylvania | 17033 | United States |
| Arcutis Clinical Site 07 | Pittsburgh | Pennsylvania | 15213 | United States |
| Arcutis Clinical Site 35 | Charleston | South Carolina | 29407 | United States |
| Arcutis Clinical Site 18 | Charleston | South Carolina | 29425 | United States |
| Arcutis Clinical Site 15 | North Charleston | South Carolina | 29420 | United States |
| Clinical Site 05 | Austin | Texas | 78759 | United States |
| Arcutis Clinical Site 03 | College Station | Texas | 77845 | United States |
| Arcutis Clinical Site 59 | Frisco | Texas | 75034 | United States |
| Arcutis Clinical Site 250 | Grapevine | Texas | 76051 | United States |
| Arcutis Clinical Site 52 | Pflugerville | Texas | 78660 | United States |
| Arcutis Clinical Site 02 | San Antonio | Texas | 78213 | United States |
| Arcutis Clinical Site 32 | Orem | Utah | 84058 | United States |
| Arcutis Clinical Site 22 | Burke | Virginia | 22015 | United States |
| Arcutis Clinical Site 17 | Norfolk | Virginia | 23502 | United States |
| Arcutis Clinical Site 12 | Calgary | Alberta | T2G 1B1 | Canada |
| Arcutis Clinical Site 09 | Surrey | British Columbia | V3R 6A7 | Canada |
| Arcutis Clinical Site 26 | Winnipeg | Manitoba | R3M 3Z4 | Canada |
| Arcutis Clinical Site 20 | Ajax | Ontario | L1S 7K8 | Canada |
| Arcutis Clinical Site 23 | London | Ontario | N6H 5L5 | Canada |
| Arcutis Clinical Site 25 | Toronto | Ontario | M4W 2N4 | Canada |
| Arcutis Clinical Site 16 | Waterloo | Ontario | N2J 1C4 | Canada |
| Arcutis Clinical Site 08 | Drummondville | Quebec | J2B 5L4 | Canada |
| Arcutis Clinical Site 27 | Québec | Quebec | H3Z 2S6 | Canada |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Roflumilast Cream 0.15% | Participants applied roflumilast cream 0.15% qd for 4 weeks. |
| BG001 | Vehicle Cream | Participants applied vehicle cream qd for 4 weeks. |
| BG002 | 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/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Randomization validated Investigator Global Assessment for Atopic Dermatitis (vIGA) Baseline Score | vIGA-AD is a 5-point scale assessing the severity of AD, with scores ranging from 0 ('clear') to 4 ('severe'), and higher scores indicate greater symptom severity. This is the baseline vIGA entered into the IWRS used for randomization. | Count of Participants | Participants |
| |||||||||||||||
| Investigator-Verified vIGA Baseline Score | vIGA-AD is a 5-point scale assessing the severity of AD, with scores ranging from 0 ('clear') to 4 ('severe'), and higher scores indicate greater symptom severity. This is the baseline vIGA data that have undergone data verification by the investigator. | Count of Participants | Participants |
| |||||||||||||||
| WI-NRS Baseline Score ≥4 | The number of participants with average, weekly baseline WI-NRS score ≥4 is presented. 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 higher scores indicating greater symptom severity. | Count of Participants | Participants |
| |||||||||||||||
| Baseline Eczema Area and Severity Index (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 (maximal disease). Note that palms and soles were treated as appropriate but were not counted towards any measurements of EASI. | Median | Inter-Quartile Range | units on a scale |
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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 Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) Success at Week 4 | The percentage of participants achieving viGA-AD "success" is presented with multiple imputation of missing observations. viGA-AD "success" is defined as a viGA-AD score of 'clear' or 'almost clear' PLUS a 2-grade improvement from Baseline. 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 only in integers of 0 to 4 where 0 is clear), with higher scores indicative of greater symptom severity. | All randomized participants are included. | Posted | Number | percentage of participants | Week 4 |
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| Secondary | Achievement of vIGA-AD Success at Week 4 in Participants With "Moderate" Baseline Scores | The percentage of participants with moderate baseline scores achieving viGA-AD "success" is presented with multiple imputation of missing observations. viGA-AD "success" is defined as a viGA-AD score of 'clear' or 'almost clear' PLUS a 2-grade improvement from baseline in participants with a 'moderate' baseline viGA-AD score. The viGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (0 'clear' to 4 'severe'), with higher scores indicative of greater symptom severity. | All randomized participants who were included in the "moderate" baseline vIGA-AD group during randomization are included. | Posted | Number | percentage of participants | Week 4 |
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| Secondary | vIGA-AD Success at Week 2 | The percentage of participants achieving viGA-AD "success" is presented with multiple imputation of missing observations. viGA-AD "success" is defined as a viGA-AD score of 'clear' or 'almost clear' PLUS a 2-grade improvement from Baseline. 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 only in integers of 0 to 4 where 0 is clear), with higher scores indicative of greater symptom severity. | All randomized participants are included. | Posted | Number | percentage of participants | Week 2 |
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| Secondary | vIGA-AD Success at Week 1 | The percentage of participants achieving viGA-AD "success" is presented with multiple imputation of missing observations. viGA-AD "success" is defined as a viGA-AD score of 'clear' or 'almost clear' PLUS a 2-grade improvement from Baseline. 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 only in integers of 0 to 4 where 0 is clear), with higher scores indicative of greater symptom severity. | All randomized participants are included. | Posted | Number | percentage of participants | Week 1 |
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| Secondary | Achievement of a 4-point Reduction at Week 4 in the Average, Weekly Worst Itch Numeric Rating Scale (WI-NRS) in Participants With Baseline WI-NRS Score ≥4 | The percentage of participants with a baseline WI-NRS ≥ 4 achieving WI-NRS success is presented with multiple imputation of missing observations. 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 participant experienced in the previous 24 hours (higher scores indicate higher itch severity). | All randomized participants who were ≥12 years of age, had an average weekly WI-NRS pruritus score ≥4 at baseline, and completed at least 4 of 7 evaluable daily WI-NRS questionnaires during the last 7 days of the Screening period are included. Multiple imputation was used to handle missing cases. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 4 |
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| Secondary | Achievement of a 4-point Reduction at Week 2 in the WI-NRS in Participants With Baseline WI-NRS Score ≥4 | The percentage of participants with a baseline WI-NRS ≥ 4 achieving WI-NRS success is presented with multiple imputation of missing observations. 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 participant experienced in the previous 24 hours (higher scores indicate higher itch severity). | All randomized participants who were ≥12 years of age, had an average weekly WI-NRS pruritus score ≥4 at baseline, and completed at least 4 of 7 evaluable daily WI-NRS questionnaires during the last 7 days of the Screening period are included. Multiple imputation was used to handle missing cases. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 2 |
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| Secondary | Achievement of a 4-point Reduction at Week 1 in the WI-NRS in Participants With Baseline WI-NRS Score ≥4 | The percentage of participants with a baseline WI-NRS ≥ 4 achieving WI-NRS success is presented with multiple imputation of missing observations. 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 participant experienced in the previous 24 hours (higher scores indicate higher itch severity). | All randomized participants who were ≥12 years of age, had an average weekly WI-NRS pruritus score ≥4 at baseline, and completed at least 4 of 7 evaluable daily WI-NRS questionnaires during the last 7 days of the Screening period are included. Multiple imputation was used to handle missing cases. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 1 |
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| Secondary | Achievement of ≥75% Decrease From Baseline at Week 4 in the Eczema Area and Severity Index (EASI-75) | The percentage of participants achieving EASI-75 is presented with multiple imputation of missing observations. EASI-75 is a ~75% reduction from the baseline EASI score. EASI combines the assessment of the severity of lesions and the area affected into a single total score in the range 0 (no disease) to 72 (maximal disease). To calculate the EASI, the sum = of the severity rating (0 to 3 with 3 being the most severe) for four clinical signs are multiplied with the numerical value of the area affected and with the percentage of the four body areas. | All randomized participants are included. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 4 |
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| Secondary | Achievement of vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 4 | The percentage of participants scoring 'clear' or 'almost clear' on viGA-AD is presented with multiple imputation of missing observations. The viGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (0 'clear' to 4 'severe'), with higher scores indicative of greater symptom severity. | All randomized participants are included. | Posted | Number | percentage of participants | Week 4 |
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| Secondary | Achievement of vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 2 | The percentage of participants scoring 'clear' or 'almost clear' on viGA-AD is presented with multiple imputation of missing observations. The viGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (0 'clear' to 4 'severe'), with higher scores indicative of greater symptom severity. | All randomized participants are included. | Posted | Number | percentage of participants | Week 2 |
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| Secondary | Achievement of vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 1 | The percentage of participants scoring 'clear' or 'almost clear' on viGA-AD is presented with multiple imputation of missing observations. The viGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (0 'clear' to 4 'severe'), with higher scores indicative of greater symptom severity. | All randomized participants are included. | Posted | Number | percentage of participants | Week 1 |
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Up to ~29 days
All randomized participants who received ≥1 dose of study intervention are included, according to actual treatment received. Note that 1 participant was randomized to vehicle but did not receive ≥1 dose of study treatment; one additional participant was randomized to vehicle but instead received active roflumilast.
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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 Cream 0.15% | Participants applied roflumilast cream 0.15% qd for 4 weeks. | 0 | 452 | 4 | 452 | 0 | 452 |
| EG001 | Vehicle Cream | Participants applied vehicle cream qd for 4 weeks. | 0 | 232 | 0 | 232 | 0 | 232 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nerve compression | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
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| Staphylococcal scalded skin syndrome | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| General physical health deterioration | General disorders | MedDRA 25.0 | Systematic Assessment |
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| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
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The process of coordinating publication efforts is detailed in the Clinical Trial Agreement.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Arcutis Medical Information | Arcutis | +1 (844) 692-6729 | medinfo@arcutis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 5, 2022 | Aug 6, 2024 | SAP_001.pdf |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Black or African-American |
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| Asian |
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| American-Indian or Alaska Native |
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| Native Hawaiian or Other Pacific Islander |
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| Multiple |
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| Other |
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| Moderate |
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| Moderate |
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| ≤3 |
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