Trial Outcomes & Findings for Safety and Efficacy of ARQ-154 Foam in Subjects With Seborrheic Dermatitis (NCT NCT04091646)
NCT ID: NCT04091646
Last Updated: 2023-07-03
Results Overview
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.
COMPLETED
PHASE2
226 participants
Week 8
2023-07-03
Participant Flow
Participant milestones
| Measure |
Roflumilast Foam 0.3%
Participants apply roflumilast foam 0.3% once daily for 8 weeks.
|
Vehicle Foam
Participants apply vehicle foam matched to roflumilast foam once daily for 8 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
154
|
72
|
|
Overall Study
COMPLETED
|
141
|
67
|
|
Overall Study
NOT COMPLETED
|
13
|
5
|
Reasons for withdrawal
| Measure |
Roflumilast Foam 0.3%
Participants apply roflumilast foam 0.3% once daily for 8 weeks.
|
Vehicle Foam
Participants apply vehicle foam matched to roflumilast foam once daily for 8 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
6
|
2
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
4
|
1
|
|
Overall Study
Participant Incarcerated
|
1
|
0
|
Baseline Characteristics
Safety and Efficacy of ARQ-154 Foam in Subjects With Seborrheic Dermatitis
Baseline characteristics by cohort
| Measure |
Roflumilast Foam 0.3%
n=154 Participants
Participants apply roflumilast foam 0.3% once daily for 8 weeks.
|
Vehicle Foam
n=72 Participants
Participants apply vehicle foam matched to roflumilast foam once daily for 8 weeks.
|
Total
n=226 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.3 years
STANDARD_DEVIATION 17.01 • n=5 Participants
|
44.2 years
STANDARD_DEVIATION 16.27 • n=7 Participants
|
44.9 years
STANDARD_DEVIATION 16.75 • n=5 Participants
|
|
Sex: Female, Male
Female
|
78 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
76 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
29 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
125 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
181 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American-Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African-American
|
17 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
123 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
185 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
More than One Race
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Investigator Global Assessment (IGA) Baseline Score
0 Completely Clear
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Investigator Global Assessment (IGA) Baseline Score
1 Almost Clear
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Investigator Global Assessment (IGA) Baseline Score
2 Mild
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Investigator Global Assessment (IGA) Baseline Score
3 Moderate
|
141 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
210 Participants
n=5 Participants
|
|
Investigator Global Assessment (IGA) Baseline Score
4 Severe
|
13 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Worst Itch Numerical Rating Scale (WI-NRS) Baseline Score
0
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Worst Itch Numerical Rating Scale (WI-NRS) Baseline Score
1
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Worst Itch Numerical Rating Scale (WI-NRS) Baseline Score
2
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Worst Itch Numerical Rating Scale (WI-NRS) Baseline Score
3
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Worst Itch Numerical Rating Scale (WI-NRS) Baseline Score
4
|
18 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Worst Itch Numerical Rating Scale (WI-NRS) Baseline Score
5
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Worst Itch Numerical Rating Scale (WI-NRS) Baseline Score
6
|
20 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Worst Itch Numerical Rating Scale (WI-NRS) Baseline Score
7
|
27 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Worst Itch Numerical Rating Scale (WI-NRS) Baseline Score
8
|
24 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Worst Itch Numerical Rating Scale (WI-NRS) Baseline Score
9
|
14 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Worst Itch Numerical Rating Scale (WI-NRS) Baseline Score
10
|
9 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Overall Assessment of Erythema Baseline Score
None
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Overall Assessment of Erythema Baseline Score
Mild
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Overall Assessment of Erythema Baseline Score
Moderate
|
135 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
201 Participants
n=5 Participants
|
|
Overall Assessment of Erythema Baseline Score
Severe
|
19 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Overall Assessment of Scaling Baseline Score
None
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Overall Assessment of Scaling Baseline Score
Mild
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Overall Assessment of Scaling Baseline Score
Moderate
|
130 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
188 Participants
n=5 Participants
|
|
Overall Assessment of Scaling Baseline Score
Severe
|
24 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 8Population: All randomized participants are included, with the exception of those who missed the Week 8 assessment due to COVID-19 disruption.
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.
Outcome measures
| Measure |
Roflumilast Foam 0.3%
n=141 Participants
Participants apply roflumilast foam 0.3% once daily for 8 weeks.
|
Vehicle Foam
n=66 Participants
Participants apply vehicle foam matched to roflumilast foam once daily for 8 weeks.
|
|---|---|---|
|
Achievement of Investigator Global Assessment (IGA) Success at Week 8
|
104 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: Weeks 2 and 4Population: All randomized participants are included, with the exception of those who missed the Week 8 assessment due to COVID-19 disruption.
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.
Outcome measures
| Measure |
Roflumilast Foam 0.3%
n=151 Participants
Participants apply roflumilast foam 0.3% once daily for 8 weeks.
|
Vehicle Foam
n=68 Participants
Participants apply vehicle foam matched to roflumilast foam once daily for 8 weeks.
|
|---|---|---|
|
Achievement of IGA Success at Weeks 2 and 4
Week 2
|
51 Participants
|
10 Participants
|
|
Achievement of IGA Success at Weeks 2 and 4
Week 4
|
81 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: Weeks 2, 4, and 8Population: All randomized participants who provided data are included, with the exception of those who missed the Week 8 assessment due to COVID-19 disruption.
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.
Outcome measures
| Measure |
Roflumilast Foam 0.3%
n=151 Participants
Participants apply roflumilast foam 0.3% once daily for 8 weeks.
|
Vehicle Foam
n=68 Participants
Participants apply vehicle foam matched to roflumilast foam once daily for 8 weeks.
|
|---|---|---|
|
Change From Baseline in Overall Assessment of Erythema Score
Week 2
|
-1.0 score on a scale
Standard Deviation 0.73
|
-0.4 score on a scale
Standard Deviation 0.65
|
|
Change From Baseline in Overall Assessment of Erythema Score
Week 4
|
-1.3 score on a scale
Standard Deviation 0.73
|
-0.7 score on a scale
Standard Deviation 0.68
|
|
Change From Baseline in Overall Assessment of Erythema Score
Week 8
|
-1.4 score on a scale
Standard Deviation 0.78
|
-0.8 score on a scale
Standard Deviation 0.85
|
SECONDARY outcome
Timeframe: Weeks 2, 4, and 8Population: All randomized participants who provided data are included, with the exception of those who missed the Week 8 assessment due to COVID-19 disruption.
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.
Outcome measures
| Measure |
Roflumilast Foam 0.3%
n=151 Participants
Participants apply roflumilast foam 0.3% once daily for 8 weeks.
|
Vehicle Foam
n=68 Participants
Participants apply vehicle foam matched to roflumilast foam once daily for 8 weeks.
|
|---|---|---|
|
Achievement of Overall Assessment of Erythema Success
Week 2
|
34 Participants
|
4 Participants
|
|
Achievement of Overall Assessment of Erythema Success
Week 4
|
51 Participants
|
7 Participants
|
|
Achievement of Overall Assessment of Erythema Success
Week 8
|
63 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Weeks 2, 4, and 8Population: All randomized participants who provided data are included, with the exception of those who missed the Week 8 assessment due to COVID-19 disruption.
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.
Outcome measures
| Measure |
Roflumilast Foam 0.3%
n=151 Participants
Participants apply roflumilast foam 0.3% once daily for 8 weeks.
|
Vehicle Foam
n=68 Participants
Participants apply vehicle foam matched to roflumilast foam once daily for 8 weeks.
|
|---|---|---|
|
Change From Baseline in Overall Assessment of Scaling Score
Week 2
|
-1.0 Score on a scale
Standard Deviation 0.77
|
-0.6 Score on a scale
Standard Deviation 0.78
|
|
Change From Baseline in Overall Assessment of Scaling Score
Week 4
|
-1.3 Score on a scale
Standard Deviation 0.76
|
-0.8 Score on a scale
Standard Deviation 0.81
|
|
Change From Baseline in Overall Assessment of Scaling Score
Week 8
|
-1.5 Score on a scale
Standard Deviation 0.75
|
-1.0 Score on a scale
Standard Deviation 0.83
|
SECONDARY outcome
Timeframe: Weeks 2, 4, and 8Population: All randomized participants who provided data are included, with the exception of those who missed the Week 8 assessment due to COVID-19 disruption.
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.
Outcome measures
| Measure |
Roflumilast Foam 0.3%
n=151 Participants
Participants apply roflumilast foam 0.3% once daily for 8 weeks.
|
Vehicle Foam
n=68 Participants
Participants apply vehicle foam matched to roflumilast foam once daily for 8 weeks.
|
|---|---|---|
|
Achievement of Overall Assessment of Scaling Success
Week 2
|
40 Participants
|
10 Participants
|
|
Achievement of Overall Assessment of Scaling Success
Week 4
|
59 Participants
|
14 Participants
|
|
Achievement of Overall Assessment of Scaling Success
Week 8
|
63 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Weeks 2, 4, and 8Population: All randomized participants who provided data are included, with the exception of those who missed the Week 8 assessment due to COVID-19 disruption.
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.
Outcome measures
| Measure |
Roflumilast Foam 0.3%
n=151 Participants
Participants apply roflumilast foam 0.3% once daily for 8 weeks.
|
Vehicle Foam
n=67 Participants
Participants apply vehicle foam matched to roflumilast foam once daily for 8 weeks.
|
|---|---|---|
|
Change From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Score
Week 2
|
-3.0 score on a scale
Standard Deviation 2.80
|
-1.7 score on a scale
Standard Deviation 2.08
|
|
Change From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Score
Week 4
|
-3.5 score on a scale
Standard Deviation 2.72
|
-1.9 score on a scale
Standard Deviation 2.22
|
|
Change From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Score
Week 8
|
-3.7 score on a scale
Standard Deviation 2.83
|
-2.0 score on a scale
Standard Deviation 2.37
|
SECONDARY outcome
Timeframe: Weeks 2, 4, and 8Population: 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.
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.
Outcome measures
| Measure |
Roflumilast Foam 0.3%
n=123 Participants
Participants apply roflumilast foam 0.3% once daily for 8 weeks.
|
Vehicle Foam
n=56 Participants
Participants apply vehicle foam matched to roflumilast foam once daily for 8 weeks.
|
|---|---|---|
|
Achievement of WI-NRS Success
Week 2
|
65 Participants
|
13 Participants
|
|
Achievement of WI-NRS Success
Week 4
|
70 Participants
|
15 Participants
|
|
Achievement of WI-NRS Success
Week 8
|
73 Participants
|
18 Participants
|
Adverse Events
Roflumilast Foam 0.3%
Vehicle Foam
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Arcutis Medical Information
Arcutis Biotherapeutics
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor is supportive of publishing clinical trial findings. The process of coordinating publication efforts is detailed in the Clinical Trial Agreement.
- Publication restrictions are in place
Restriction type: OTHER