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This is an open-label, long-term safety study of roflumilast ARQ-154 foam 0.3% in subjects with seborrheic dermatitis involving up to 20% total Body Surface Area (BSA). Study was applied topically once daily for 52 weeks. Cohort 1 subjects are rollover subjects from study ARQ-154-203 (NCT04091646) and were rolled into treatment in the current study without interruption. Cohort 2 includes participants from ARQ-154-203 who began treatment in the current study after a gap from completing treatment in the prior study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Long-term safety of ARQ-154 | Experimental | Open-label, Long-term Safety of ARQ-154 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARQ-154 | Drug | ARQ-154 foam 0.3% applied once daily for 52 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With ≥1 Adverse Event (AE) | The number of participants with treatment-emergent AEs is reported. An AE is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to participation in the research. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study. | Up to 52 weeks |
| Number of Participants With ≥1 Serious Adverse Event (SAE) | The number of participants with treatment-emergent SAEs is reported. An SAE is any AE that results in death, is life-threatening (places the subject at immediate risk of death from the event as it occurred), requires inpatient hospitalization or prolongation of existing hospitalization, results in a persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, or is any other adverse event that, based upon appropriate medical judgment, may jeopardize the subject's health. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study. | Up to 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With an Investigator Global Assessment (IGA) Score of Completely Clear or Almost Clear | The number of participants with an IGA score of 0 ('completely clear') or 1 ('almost clear') is presented. The IGA is a 5-point scale assessing the severity of seborrheic dermatitis, with scores ranging from 0 ('clear') to 4 ('severe'), and higher scores indicate greater symptom severity. |
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Inclusion Criteria:
Participants legally competent to sign and give informed consent or (for adolescents) assent.
Males and females ages 9 years and older (inclusive) at the time of consent.
Females of childbearing potential (FOCBP) must have a negative serum pregnancy test at all study visits.
Post-menopausal women with spontaneous amenorrhea for at least 12 months or have undergone surgical sterilization.
Cohort 1 only:
Subjects with seborrheic dermatitis who met eligibility criteria for a prior ARQ-154 study, successfully completed a prior ARQ-154 study through final visit and are able to immediately enroll into this long-term safety study on the final visit of the previous ARQ-154 study.
Cohort 2 subjects that have not participated in a prior ARQ-154 study:
Clinical diagnosis of seborrheic dermatitis of at least 3 months duration as determined by the Investigator. Stable disease for the past 4 weeks.
Seborrheic dermatitis of the scalp and/or face and/or trunk and/or intertriginous areas up to ≤20% BSA involvement.
An Investigator Global Assessment (IGA) of disease severity of at least Moderate ('3') at Day 1.
Overall Assessment of Erythema and Overall Assessment of Scaling scores of Moderate ('2') at Day 1.
Cohort 2 subjects that have participated in a prior ARQ-154 study:
Clinical diagnosis of seborrheic dermatitis of at least 3 months duration as determined by the Investigator.
Seborrheic dermatitis of the scalp and/or face and/or trunk and/or intertriginous areas up to ≤20% BSA involvement.
Exclusion Criteria:
Planned excessive exposure of treated area(s) to either natural or artificial sunlight, tanning bed or other LED.
Subjects with any condition on the treatment area which, in the opinion of the Investigator, could confound efficacy measurements.
Subjects unable to apply investigational product to the scalp due to physical limitation.
Known allergies to excipients in ARQ-154 foam.
Subjects who cannot discontinue the use of strong P-450 cytochrome inhibitors e.g., indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketoconazole, nefazodone, saquinavir, suboxone and telithromycin during the study period.
Known or suspected:
Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
Subjects with any serious medical condition or laboratory abnormality that would prevent study participation or place the subject at significant risk, as determined by the Investigator.
Subjects with a history of chronic alcohol or drugs abuse within 6 months of initiation of investigational product.
Current or a history of cancer within 5 years with the exception of fully treated skin basal cell carcinoma, cutaneous squamous cell carcinoma or carcinoma in situ of the cervix.
Subjects who are unable to communicate, read or understand the local language, or who display another condition, which in the Investigator's opinion, makes them unsuitable for clinical study participation.
Subjects who are family members of the clinical study site, clinical study staff, or sponsor, or family members that live in the same household of enrolled subjects.
Cohort 1 only:
Subjects who experienced an ARQ-154 treatment-related AE or a serious AE (SAE) that precluded further treatment with ARQ-154 foam in a prior ARQ-154 study.
Subjects that use any Excluded Medication and Treatments.
Cohort 2 only:
Subjects who cannot discontinue treatment with therapies for the treatment of seborrheic dermatitis prior to the Day 1 visit and during the study according to Excluded Medications and Treatments.
Subjects with PHQ-8 >10 or modified PHQ-A >10 at Screening or Day 1.
Cohort 2 subjects that have participated in a prior ARQ-154 study:
Subjects who experienced an ARQ-154 treatment-related AE or a serious AE (SAE) that precluded further treatment with ARQ-154 foam in a prior ARQ-154 study.
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| Name | Affiliation | Role |
|---|---|---|
| David Berk, MD | Arcutis Biotherapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arcutis Biotherapeutics Clinical Site 59 | Beverly Hills | California | 90212 | United States | ||
| Arcutis Biotherapeutics Clinical Site 51 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41175336 | Derived | Alexis AF, Bukhalo M, Cook-Bolden FE, Del Rosso JQ, Draelos ZD, DuBois JC, Ferris LK, Forman SB, Kempers SE, Kircik LH, Lain E, Moore AY, Pariser DM, Raoof J, Zirwas MJ, Seal MS, Kato S, Chu DH, Krupa D, Snyder S, Burnett P, Berk DR. Long-Term Safety and Efficacy of Roflumilast Foam 0.3% in Patients with Seborrheic Dermatitis: A Phase II, Open-Label Trial of up to 52 Weeks. Am J Clin Dermatol. 2026 Jan;27(1):189-198. doi: 10.1007/s40257-025-00984-2. Epub 2025 Nov 1. |
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Participants from study ARQ-154-203 were rolled over primarily into this study. A subset of participants from study ARQ-154-116 was also enrolled (Cohort 1 Group 2); these participants are not included in the efficacy analyses but baseline and safety information is presented.
Participants were enrolled at 39 study centers in the US.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 Group 1: ARQ-154-203 Roflumilast Foam 0.3% Without Treatment Gap | Participants from ARQ-154-203 using roflumilast (ARQ-154) foam 0.3% in the prior study applied roflumilast foam 0.3% QD for 52 weeks in the present study with no gap in treatment. |
| FG001 | Cohort 1 Group 1: ARQ 154-203 Vehicle Foam Rolled Over Without Treatment Gap |
| 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, 2021 | Jan 12, 2024 |
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Subjects that consent to enter this open-label safety study may or may not have previously completed a companion study (ARQ-154 trial)
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| Weeks 4, 12, 24, 36, and 52 |
| Achievement of IGA Success | The number of participants achieving "success" in IGA assessment of disease severity is presented. Success was defined as achievement of an IGA score of 0 ('clear') or 1 ('almost clear') at Week 8, accompanied by a ≥2-grade improvement from baseline IGA score. The IGA is a 5-point scale assessing the severity of seborrheic dermatitis, with scores ranging from 0 ('clear') to 4 ('severe'), and higher scores indicate greater symptom severity. | Weeks 4, 12, 24, 36, and 52 |
| Duration of IGA Success | The duration of "success" in IGA assessment of disease severity is presented. Success was defined as achievement of an IGA score of 0 ('clear') or 1 ('almost clear') at Week 8, accompanied by a ≥2-grade improvement from baseline IGA score. The IGA is a 5-point scale assessing the severity of seborrheic dermatitis, with scores ranging from 0 ('clear') to 4 ('severe'), and higher scores indicate greater symptom severity. The time from first observation of IGA success to the first subsequent time a participant's disease response did not meet the criteria for IGA success is presented. The duration of IGA success for subjects who ended treatment in IGA success was censored at the last disease assessment date. | Weeks 4, 12, 24, 36, and 52 |
| IGA Treatment-Free Interval | The treatment-free interval is defined as time from when the participant achieves disease clearance (IGA score of 0 ["completely clear"]) and stops treatment of all lesions until the time of restarting treatment. | Weeks 4, 12, 24, 36, and 52 |
| Encino |
| California |
| 91436 |
| United States |
| Arcutis Biotherapeutics Clinical Site 75 | Fountain Valley | California | 92708 | United States |
| Arcutis Biotherapeutics Clinical Site 19 | Fremont | California | 94538 | United States |
| Arcutis Biotherapeutics Clinical Site 62 | Los Angeles | California | 90036 | 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 53 | Aventura | Florida | 33180 | 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 24 | Miami | Florida | 33144 | 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 22 | Plainfield | Indiana | 46168 | United States |
| Arcutis Biotherapeutics Clinical Site 15 | Louisville | Kentucky | 40217 | United States |
| Arcutis Biotherapeutics Clinical Site 52 | Metairie | Louisiana | 70006 | United States |
| Arcutis Biotherapeutics Clinical Site 28 | Rockville | Maryland | 20850 | United States |
| Arcutis Biotherapeutics Clinical Site 73 | Brighton | Massachusetts | 02135 | 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 58 | Fort Gratiot | Michigan | 48059 | United States |
| Arcutis Biotherapeutics Clinical Site 14 | Fridley | Minnesota | 55432 | United States |
| Arcutis Biotherapeutics Clinical Site 50 | Las Vegas | Nevada | 89148 | United States |
| Arcutis Biotherapeutics Clinical Site 56 | Portsmouth | New Hampshire | 03801 | United States |
| Arcutis Biotherapeutics Clinical Site 55 | New York | New York | 10029 | 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 18 | Bexley | Ohio | 43209 | United States |
| Arcutis Biotherapeutics Clinical Site 29 | Portland | Oregon | 97210 | United States |
| Arcutis Biotherapeutics Clinical Site 27 | Pittsburgh | Pennsylvania | 15213 | United States |
| Arcutis Biotherapeutics Clinical Site 76 | Charleston | South Carolina | 29407 | 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 25 | Houston | Texas | 77056 | United States |
| Arcutis Biotherapeutics Clinical Site 26 | Pflugerville | Texas | 78660 | United States |
| Arcutis Biotherapeutics Clinical Site 54 | San Antonio | Texas | 78213 | United States |
| Arcutis Biotherapeutics Clinical Site 17 | Norfolk | Virginia | 23502 | United States |
Participants from ARQ-154-203 using vehicle foam in the prior study applied roflumilast foam 0.3% QD for 52 weeks in the present study with no gap in treatment. |
| FG002 | Cohort 2 Group 3: ARQ-154-203 Roflumilast Foam 0.3% With Treatment Gap | Participants from ARQ-154-203 using roflumilast foam in the prior study applied roflumilast foam 0.3% QD for 52 weeks in the present study with a gap in treatment. |
| FG003 | Cohort 2 Group 3: ARQ-154-203 Vehicle Foam With Treatment Gap | Participants from ARQ-154-203 using vehicle foam in the prior study applied roflumilast foam 0.3% QD for 52 weeks in the present study with a gap in treatment. |
| FG004 | Cohort 2 Group 4: De Novo Participants | Treatment naive participants who had not previously participated in a clinical study of roflumilast foam 0.3% applied roflumilast foam 0.3% QD for 52 weeks in the present study. |
| FG005 | Cohort 1 Group 2: ARQ-154-116 Rollover | Participants from study ARQ-154-116 applied roflumilast foam 0.3% in the present study. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Efficacy data were not summarized for participants from Cohort 1 Group 2.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 Group 1: ARQ-154-203 Roflumilast Foam 0.3% Without Treatment Gap | Participants from ARQ-154-203 using roflumilast (ARQ-154) foam 0.3% in the prior study applied roflumilast foam 0.3% QD for 52 weeks in the present study with no gap in treatment. |
| BG001 | Cohort 1 Group 1: ARQ 154-203 Vehicle Foam Rolled Over Without Treatment Gap | Participants from ARQ-154-203 using vehicle foam in the prior study applied roflumilast foam 0.3% QD for 52 weeks in the present study with no gap in treatment. |
| BG002 | Cohort 2 Group 3: ARQ-154-203 Roflumilast Foam 0.3% With Treatment Gap | Participants from ARQ-154-203 using roflumilast foam in the prior study applied roflumilast foam 0.3% QD for 52 weeks in the present study with a gap in treatment. |
| BG003 | Cohort 2 Group 3: ARQ-154-203 Vehicle Foam With Treatment Gap | Participants from ARQ-154-203 using vehicle foam in the prior study applied roflumilast foam 0.3% QD for 52 weeks in the present study with a gap in treatment. |
| BG004 | Cohort 2 Group 4: De Novo Participants | Treatment naive participants who had not previously participated in a clinical study of roflumilast foam 0.3% applied roflumilast foam 0.3% QD for 52 weeks in the present study. |
| BG005 | Cohort 1 Group 2: ARQ-154-116 Rollover | Participants from study ARQ-154-116 applied roflumilast foam 0.3% in the present study. |
| BG006 | 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 |
| ||||||||||||||||
| Investigator Global Assessment (IGA) Baseline Score | The IGA is a 5-point scale assessing the severity of seborrheic dermatitis, with scores ranging from 0 ('clear') to 4 ('severe'), and higher scores indicate greater symptom severity. | 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 Adverse Event (AE) | The number of participants with treatment-emergent AEs is reported. An AE is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to participation in the research. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study. | All participants are included. | Posted | Count of Participants | Participants | Up to 52 weeks |
|
|
| |||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With ≥1 Serious Adverse Event (SAE) | The number of participants with treatment-emergent SAEs is reported. An SAE is any AE that results in death, is life-threatening (places the subject at immediate risk of death from the event as it occurred), requires inpatient hospitalization or prolongation of existing hospitalization, results in a persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, or is any other adverse event that, based upon appropriate medical judgment, may jeopardize the subject's health. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study. | All participants are included. | Posted | Count of Participants | Participants | Up to 52 weeks |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With an Investigator Global Assessment (IGA) Score of Completely Clear or Almost Clear | The number of participants with an IGA score of 0 ('completely clear') or 1 ('almost clear') is presented. The IGA is a 5-point scale assessing the severity of seborrheic dermatitis, with scores ranging from 0 ('clear') to 4 ('severe'), and higher scores indicate greater symptom severity. | All treated participants with data available and who had baseline IGA score >1 are included. | Posted | Count of Participants | Participants | Weeks 4, 12, 24, 36, and 52 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Achievement of IGA Success | The number of participants achieving "success" in IGA assessment of disease severity is presented. Success was defined as achievement of an IGA score of 0 ('clear') or 1 ('almost clear') at Week 8, accompanied by a ≥2-grade improvement from baseline IGA score. The IGA is a 5-point scale assessing the severity of seborrheic dermatitis, with scores ranging from 0 ('clear') to 4 ('severe'), and higher scores indicate greater symptom severity. | All treated participants with data available and who had baseline IGA score ≥2 are included. | Posted | Count of Participants | Participants | Weeks 4, 12, 24, 36, and 52 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Duration of IGA Success | The duration of "success" in IGA assessment of disease severity is presented. Success was defined as achievement of an IGA score of 0 ('clear') or 1 ('almost clear') at Week 8, accompanied by a ≥2-grade improvement from baseline IGA score. The IGA is a 5-point scale assessing the severity of seborrheic dermatitis, with scores ranging from 0 ('clear') to 4 ('severe'), and higher scores indicate greater symptom severity. The time from first observation of IGA success to the first subsequent time a participant's disease response did not meet the criteria for IGA success is presented. The duration of IGA success for subjects who ended treatment in IGA success was censored at the last disease assessment date. | All treated participants who achieved IGA success and had data available are included. | Posted | Median | Full Range | weeks | Weeks 4, 12, 24, 36, and 52 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | IGA Treatment-Free Interval | The treatment-free interval is defined as time from when the participant achieves disease clearance (IGA score of 0 ["completely clear"]) and stops treatment of all lesions until the time of restarting treatment. | All treated participants who achieved an IGA score of 0 are included. | Posted | Median | Full Range | weeks | Weeks 4, 12, 24, 36, and 52 |
|
Up to 52 weeks
All participants are included. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study.
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 | Cohort 1 Group 1: ARQ-154-203 Roflumilast Foam 0.3% Without Treatment Gap | Participants from ARQ-154-203 using roflumilast foam 0.3% or vehicle foam in the prior study applied roflumilast foam 0.3% QD for 52 weeks in the present study with no gap in treatment. | 0 | 75 | 2 | 75 | 3 | 75 |
| EG001 | Cohort 2 Group 3: ARQ-154-203 Roflumilast Foam 0.3% Without Treatment Gap | Participants from ARQ-154-203 using roflumilast 0.3% or vehicle foam in the prior study applied roflumilast foam 0.3% QD for 52 weeks in the present study with a gap in treatment. | 0 | 58 | 0 | 58 | 4 | 58 |
| EG002 | Cohort 2 Group 4: De Novo Participants | Treatment naive participants who had not previously participated in a clinical study of roflumilast foam 0.3% applied roflumilast foam 0.3% QD for 52 weeks in the present study. | 1 | 267 | 5 | 267 | 11 | 267 |
| EG003 | Cohort 1 Group 2: ARQ-154-116 Rollover | Participants from study ARQ-154-116 applied roflumilast foam 0.3% in the present study. | 0 | 8 | 0 | 8 | 6 | 8 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Performance status decreased | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Brain neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Tic | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Application site alopecia | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Pyogenic granuloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
|
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 | Feb 18, 2022 | Jan 12, 2024 | SAP_001.pdf |
Not provided
| 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 |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Black or African-American |
|
| Native Hawaii or Other Pacific Islander |
|
| White |
|
| Other |
|
| More than one race |
|
| Missing |
|
| 1 = Almost clear |
|
| 2 = Mild |
|
| 3 = Moderate |
|
| 4 = Severe |
|
| Cohort 2 Group 4: De Novo Participants |
Treatment naive participants who had not previously participated in a clinical study of roflumilast foam 0.3% applied roflumilast foam 0.3% QD for 52 weeks in the present study. |
| OG003 | Cohort 1 Group 2: ARQ-154-116 Rollover | Participants from study ARQ-154-116 applied roflumilast foam 0.3% in the present study. |
|
|
| OG003 | Cohort 2 Group 3: ARQ-154-203 Vehicle Foam With Treatment Gap | Participants from ARQ-154-203 using vehicle foam in the prior study applied roflumilast foam 0.3% QD for 52 weeks in the present study with a gap in treatment. |
| OG004 | Cohort 2 Group 4: De Novo Participants | Treatment naive participants who had not previously participated in a clinical study of roflumilast foam 0.3% applied roflumilast foam 0.3% QD for 52 weeks in the present study. |
| OG005 | Cohort 1 Group 2: ARQ-154-116 Rollover | Participants from study ARQ-154-116 applied roflumilast foam 0.3% in the present study. |
|
|
Participants from ARQ-154-203 using roflumilast foam in the prior study applied roflumilast foam 0.3% QD for 52 weeks in the present study with a gap in treatment.
| OG003 | Cohort 2 Group 3: ARQ-154-203 Vehicle Foam With Treatment Gap | Participants from ARQ-154-203 using vehicle foam in the prior study applied roflumilast foam 0.3% QD for 52 weeks in the present study with a gap in treatment. |
| OG004 | Cohort 2 Group 4: De Novo Participants | Treatment naive participants who had not previously participated in a clinical study of roflumilast foam 0.3% applied roflumilast foam 0.3% QD for 52 weeks in the present study. |
| OG005 | Cohort 1 Group 2: ARQ-154-116 Rollover | Participants from study ARQ-154-116 applied roflumilast foam 0.3% in the present study. |
|
|
| OG002 | Cohort 2 Group 3: ARQ-154-203 Roflumilast Foam 0.3% With Treatment Gap | Participants from ARQ-154-203 using roflumilast foam in the prior study applied roflumilast foam 0.3% QD for 52 weeks in the present study with a gap in treatment. |
| OG003 | Cohort 2 Group 3: ARQ-154-203 Vehicle Foam With Treatment Gap | Participants from ARQ-154-203 using vehicle foam in the prior study applied roflumilast foam 0.3% QD for 52 weeks in the present study with a gap in treatment. |
| OG004 | Cohort 2 Group 4: De Novo Participants | Treatment naive participants who had not previously participated in a clinical study of roflumilast foam 0.3% applied roflumilast foam 0.3% QD for 52 weeks in the present study. |
| OG005 | Cohort 1 Group 2: ARQ-154-116 Rollover | Participants from study ARQ-154-116 applied roflumilast foam 0.3% in the present study. |
|
|
| OG003 | Cohort 2 Group 3: ARQ-154-203 Vehicle Foam With Treatment Gap | Participants from ARQ-154-203 using vehicle foam in the prior study applied roflumilast foam 0.3% QD for 52 weeks in the present study with a gap in treatment. |
| OG004 | Cohort 2 Group 4: De Novo Participants | Treatment naive participants who had not previously participated in a clinical study of roflumilast foam 0.3% applied roflumilast foam 0.3% QD for 52 weeks in the present study. |
| OG005 | Cohort 1 Group 2: ARQ-154-116 Rollover | Participants from study ARQ-154-116 applied roflumilast foam 0.3% in the present study. |
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