Safety and Efficacy of ARQ-154 Foam in Subjects With Sebo... | NCT04091646

Label	Type	Description	Intervention Names
Roflumilast Foam 0.3%	Active Comparator	Participants apply roflumilast foam 0.3% once daily (QD) to all areas of seborrheic dermatitis once daily for 8 weeks.	Drug: Roflumilast Foam 0.3%
Vehicle Foam	Placebo Comparator	Participants apply inactive vehicle foam matched to roflumilast foam QD for 8 weeks.	Drug: Vehicle foam

Name	Type	Description	Arm Group Labels	Other Names
Roflumilast Foam 0.3%	Drug	Roflumilast foam for topical application.	Roflumilast Foam 0.3%

Measure	Description	Time Frame
Achievement of Investigator Global Assessment (IGA) Success at Week 8	The number of participants achieving "success" in IGA assessment of disease severity at Week 8 is presented for each arm. Success was defined as achievement of an IGA score of 0 ('completely clear') or 1 ('almost clear'), accompanied by a ≥2-grade improvement from baseline IGA score. The IGA is 5-point scale assessing the severity of Seborrheic Dermatitis, with scores ranging from 0 ('completely clear') to 4 ('severe'), and higher scores indicate greater severity. The IGA scores are based on observed data, whereas odds ratio and p-values were calculated using multiple imputation of missing values.	Week 8

Measure	Description	Time Frame
Achievement of IGA Success at Weeks 2 and 4	The number of participants achieving "success" in IGA assessment of disease severity at Weeks 2 and 4 is presented for each arm. Success was defined as achievement of an IGA score of 0 ('completely clear') or 1 ('almost clear'), accompanied by a ≥2-grade improvement from baseline IGA score. The IGA is 5-point scale assessing the severity of Seborrheic Dermatitis, with scores ranging from 0 ('completely clear') to 4 ('severe'), and higher scores indicate greater severity. The IGA scores are based on observed data, whereas odds ratio and p-values were calculated using multiple imputation of missing values.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participants legally competent to sign and give informed consent.
Males and females ages 18 years and older (inclusive) at the time of consent.
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.
An Investigator Global Assessment (IGA) of disease severity of at least Moderate ('3') at Baseline.
Overall Assessment of Erythema and Overall Assessment of Scaling scores of at least Moderate ('2') at Baseline.
Females of childbearing potential (FOCBP) must have a negative serum pregnancy test at Screening (Visit 1) and a negative urine pregnancy test at Baseline (Visit 2).
Females of non-childbearing potential must either be post-menopausal with spontaneous amenorrhea for at least 12 months or have undergone surgical sterilization.
Subjects in good health as judged by the Investigator, based on medical history, physical examination, vital signs, serum chemistry labs, hematology values, and urinalysis.
Subjects are considered reliable and capable of adhering to the Protocol and visit schedule according to the Investigator judgment.

Exclusion Criteria:

Subjects who cannot discontinue treatment with therapies for the treatment of seborrheic dermatitis prior to the Baseline visit and during the study according to Excluded Medications and Treatments.
Planned excessive exposure of treated area(s) to either natural or artificial sunlight, tanning bed or other LED.
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 for two weeks prior to the Baseline visit (Visit 2) and during the study.
Subjects who cannot discontinue the use of strong P-450 cytochrome inducers e.g., efavirenz, nevirapine, glucocorticoids, barbiturates (including phenobarbital), phenytoin, rifampin, and carbamazepine for two weeks prior to the Baseline visit (Visit 2) and during the study.
Subjects with PHQ-8 ≥10 at Screening or Baseline visits.
Previous treatment with ARQ-151 and ARQ-154.
Subjects who have received oral roflumilast (Daliresp®, Daxas®) or other PDE-4 inhibitors (apremilast) within the past 4 weeks.
Known allergies to excipients in ARQ-154 foam.
Known or suspected: severe renal insufficiency or moderate to severe hepatic disorders; hypersensitivity to component(s) of the investigational products; or history of severe depression, suicidal ideation, or Baseline/Screening C-SSRS indicative of suicidal ideation, whether lifetime or recent/current.
Subjects with a history of a major surgery within 8 weeks prior to Baseline (Visit 2) or has a major surgery planned during the study.
Subjects with any condition on the treatment area which, in the opinion of the Investigator, could confound efficacy measurements.
Subjects unable to apply product to the scalp due to physical limitations.
Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
A clinically relevant history of abuse of alcohol or other drugs, at the discretion of the Investigator.
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 of enrolled subjects.
Any condition that in the Investigator's assessment would preclude the subject from participating in the study.

Name	Affiliation	Role
David Berk, MD	Arcutis Biotherapeutics, Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Arcutis Biotherapeutics Clinical Site 19		Fremont	California	94538	United States
Arcutis Biotherapeutics Clinical Site 21

PubMed Identifier	Type	Citation	Retractions
37133856	Derived	Zirwas MJ, Draelos ZD, DuBois J, Kircik LH, Moore AY, Stein Gold L, Alonso-Llamazares J, Bukhalo M, Bruce S, Eads K, Green LJ, Guenthner ST, Ferris LK, Forman SB, Kempers SE, Lain E, Lynde CW, Pariser DM, Toth DP, Yamauchi PS, Higham RC, Krupa D, Burnett P, Berk DR. Efficacy of Roflumilast Foam, 0.3%, in Patients With Seborrheic Dermatitis: A Double-blind, Vehicle-Controlled Phase 2a Randomized Clinical Trial. JAMA Dermatol. 2023 Jun 1;159(6):613-620. doi: 10.1001/jamadermatol.2023.0846.

ID	Title	Description
FG000	Roflumilast Foam 0.3%	Participants apply roflumilast foam 0.3% once daily for 8 weeks.
FG001	Vehicle Foam	Participants apply vehicle foam matched to roflumilast foam once daily for 8 weeks.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jan 7, 2020	May 2, 2023

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00045.3± 17.01 BG00144.2± 16.27 BG00244.9± 16.75

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00078 BG00132 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00029 BG00116 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

American-Indian or Alaska Native

Title	Measurements
	BG0001 BG0010 BG002

Investigator Global Assessment (IGA) Baseline Score

The IGA is 5-point scale assessing the severity of seborrheic dermatitis, with scores ranging from 0 ('completely clear') to 4 ('severe'), with higher scores indicating greater severity.

Count of Participants

Participants

Title

Denominators

Categories

0 Completely Clear

Title	Measurements
	BG0000 BG001

Worst Itch Numerical Rating Scale (WI-NRS) Baseline Score

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 subject experienced in the previous 24 hours. Higher scores indicate greater severity.

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
	BG0007 BG001

Overall Assessment of Erythema Baseline Score

The Overall Assessment of Erythema 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.

Count of Participants

Participants

Title

Denominators

Categories

None

Title	Measurements
	BG0000 BG001

Overall Assessment of Scaling Baseline Score

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 severity.

Count of Participants

Participants

Title

Denominators

Categories

None

Title	Measurements
	BG0000 BG001

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 Investigator Global Assessment (IGA) Success at Week 8

The number of participants achieving "success" in IGA assessment of disease severity at Week 8 is presented for each arm. Success was defined as achievement of an IGA score of 0 ('completely clear') or 1 ('almost clear'), accompanied by a ≥2-grade improvement from baseline IGA score. The IGA is 5-point scale assessing the severity of Seborrheic Dermatitis, with scores ranging from 0 ('completely clear') to 4 ('severe'), and higher scores indicate greater severity. The IGA scores are based on observed data, whereas odds ratio and p-values were calculated using multiple imputation of missing values.

All randomized participants are included, with the exception of those who missed the Week 8 assessment due to COVID-19 disruption.

Posted

Count of Participants

Participants

Week 8

ID	Title	Description
OG000	Roflumilast Foam 0.3%	Participants apply roflumilast foam 0.3% once daily for 8 weeks.
OG001	Vehicle Foam	Participants apply vehicle foam matched to roflumilast foam once daily for 8 weeks.

Units	Counts
Participants	OG000141 OG00166

Title

Denominators

Categories

Title	Measurements
	OG000104 OG00127

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	IGA Success at Week 8 Odds Ratio	Cochran-Mantel-Haenszel	Stratification by pooled study site and baseline IGA per randomization with multiple imputation of missing data	<0.0001		Odds Ratio (OR)	4.95			2-Sided	95	2.51	9.76			Common OR stratified by pooled study site and baseline IGA per randomization with multiple imputation of missing data.		Superiority

Secondary

Achievement of IGA Success at Weeks 2 and 4

The number of participants achieving "success" in IGA assessment of disease severity at Weeks 2 and 4 is presented for each arm. Success was defined as achievement of an IGA score of 0 ('completely clear') or 1 ('almost clear'), accompanied by a ≥2-grade improvement from baseline IGA score. The IGA is 5-point scale assessing the severity of Seborrheic Dermatitis, with scores ranging from 0 ('completely clear') to 4 ('severe'), and higher scores indicate greater severity. The IGA scores are based on observed data, whereas odds ratio and p-values were calculated using multiple imputation of missing values.

All randomized participants are included, with the exception of those who missed the Week 8 assessment due to COVID-19 disruption.

Posted

Count of Participants

Participants

Weeks 2 and 4

ID	Title	Description
OG000	Roflumilast Foam 0.3%	Participants apply roflumilast foam 0.3% once daily for 8 weeks.
OG001	Vehicle Foam	Participants apply vehicle foam matched to roflumilast foam once daily for 8 weeks.

Units	Counts
Participants

Secondary

Change From Baseline in Overall Assessment of Erythema Score

The mean (SD) change from baseline in Overall Assessment of Erythema score at Weeks 2, 4, and 8 is shown. 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 who provided data are included, with the exception of those who missed the Week 8 assessment due to COVID-19 disruption.

Posted

Mean

Standard Deviation

score on a scale

Weeks 2, 4, and 8

ID	Title	Description
OG000	Roflumilast Foam 0.3%	Participants apply roflumilast foam 0.3% once daily for 8 weeks.
OG001	Vehicle Foam	Participants apply vehicle foam matched to roflumilast foam once daily for 8 weeks.

Units	Counts
Participants	OG000

Secondary

Achievement of Overall Assessment of Erythema Success

The number of participants achieving "success" in Overall Assessment of Erythema at Weeks 2, 4, and 8 is presented for each arm. Success was defined as achievement of an overall score of 0 or 1 plus a ≥2 grade improvement from Baseline. The Overall Assessment of Erythema 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 who provided data are included, with the exception of those who missed the Week 8 assessment due to COVID-19 disruption.

Posted

Count of Participants

Participants

Weeks 2, 4, and 8

ID	Title	Description
OG000	Roflumilast Foam 0.3%	Participants apply roflumilast foam 0.3% once daily for 8 weeks.
OG001	Vehicle Foam	Participants apply vehicle foam matched to roflumilast foam once daily for 8 weeks.

Units	Counts
Participants

Secondary

Change From Baseline in Overall Assessment of Scaling Score

The mean (SD) change from baseline in Overall Assessment of Scaling score at Weeks 2, 4, and 8 is shown. 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 severity.

All randomized participants who provided data are included, with the exception of those who missed the Week 8 assessment due to COVID-19 disruption.

Posted

Mean

Standard Deviation

Score on a scale

Weeks 2, 4, and 8

ID	Title	Description
OG000	Roflumilast Foam 0.3%	Participants apply roflumilast foam 0.3% once daily for 8 weeks.
OG001	Vehicle Foam	Participants apply vehicle foam matched to roflumilast foam once daily for 8 weeks.

Units	Counts
Participants

Secondary

Achievement of Overall Assessment of Scaling Success

The number of participants achieving "success" in Overall Assessment of Scaling score at Weeks 2, 4, and 8 is presented for each arm. Success was defined as achievement of an Overall Assessment of Scaling score of 0 or 1 plus a ≥2 grade improvement from Baseline. 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 severity.

All randomized participants who provided data are included, with the exception of those who missed the Week 8 assessment due to COVID-19 disruption.

Posted

Count of Participants

Participants

Weeks 2, 4, and 8

ID	Title	Description
OG000	Roflumilast Foam 0.3%	Participants apply roflumilast foam 0.3% once daily for 8 weeks.
OG001	Vehicle Foam	Participants apply vehicle foam matched to roflumilast foam once daily for 8 weeks.

Units	Counts
Participants

Secondary

Change From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Score

The change from baseline in WI-NRS is shown. 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 subject experienced in the previous 24 hours. Negative values represent a decrease in worst itch from baseline, and positive values indicate an increase.

All randomized participants who provided data are included, with the exception of those who missed the Week 8 assessment due to COVID-19 disruption.

Posted

Mean

Standard Deviation

score on a scale

Weeks 2, 4, and 8

ID	Title	Description
OG000	Roflumilast Foam 0.3%	Participants apply roflumilast foam 0.3% once daily for 8 weeks.
OG001	Vehicle Foam	Participants apply vehicle foam matched to roflumilast foam once daily for 8 weeks.

Units	Counts
Participants	OG000

Secondary

Achievement of WI-NRS Success

The number of participants achieving WI-NRS "success" at Weeks 2, 4, and 8 is presented. Success was defined as achievement of a ≥4-point improvement from baseline WI-NRS score. 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 subject experienced in the previous 24 hours.

All randomized participants who provided data are included, with the exception of those who missed the Week 8 assessment due to COVID-19 disruption or those with baseline WI-NRS <4.

Posted

Count of Participants

Participants

Weeks 2, 4, and 8

ID	Title	Description
OG000	Roflumilast Foam 0.3%	Participants apply roflumilast foam 0.3% once daily for 8 weeks.
OG001	Vehicle Foam	Participants apply vehicle foam matched to roflumilast foam once daily for 8 weeks.

Units	Counts
Participants

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 apply roflumilast foam 0.3% once daily for 8 weeks.	0	154	0	154	0	154
EG001	Vehicle Foam	Participants apply vehicle foam matched to roflumilast foam once daily for 8 weeks.	0	72	0	72	0	72

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

ID	Title	Description
BG000	Roflumilast Foam 0.3%	Participants apply roflumilast foam 0.3% once daily for 8 weeks.
BG001	Vehicle Foam	Participants apply vehicle foam matched to roflumilast foam once daily for 8 weeks.
BG002	Total	Total of all reporting groups