Trial Outcomes & Findings for Trial of PDE4 Inhibition With Roflumilast (ARQ-154) Foam 0.3% for the Management of Seborrheic Dermatitis (STRATUM) (NCT NCT04973228)
NCT ID: NCT04973228
Last Updated: 2024-03-12
Results Overview
The percentage of participants achieving IGA "success" is presented. Success is defined as a score of 0 ('clear') or 1 ('almost clear') plus a 2-point improvement at Week 8. The IGA is 5-point scale assessing the severity of seborrheic dermatitis with total scores ranging from 0 ('clear') to 4 ('severe') \[higher scores indicating greater severity\].
COMPLETED
PHASE3
457 participants
Week 8
2024-03-12
Participant Flow
Participants were enrolled at 50 study centers in the US and Canada.
Participant milestones
| Measure |
Roflumilast Foam 0.3%
Participants with seborrheic dermatitis applied roflumilast foam 0.3% once daily (QD) for 8 weeks.
|
Vehicle Foam
Participants with seborrheic dermatitis applied vehicle foam QD for 8 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
304
|
153
|
|
Overall Study
COMPLETED
|
276
|
138
|
|
Overall Study
NOT COMPLETED
|
28
|
15
|
Reasons for withdrawal
| Measure |
Roflumilast Foam 0.3%
Participants with seborrheic dermatitis applied roflumilast foam 0.3% once daily (QD) for 8 weeks.
|
Vehicle Foam
Participants with seborrheic dermatitis applied vehicle foam QD for 8 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
3
|
|
Overall Study
Lack of Efficacy
|
1
|
3
|
|
Overall Study
Lost to Follow-up
|
12
|
4
|
|
Overall Study
Withdrawal by Subject
|
11
|
4
|
|
Overall Study
Did not tolerate application
|
1
|
0
|
|
Overall Study
Wanted to early terminate and use own product
|
0
|
1
|
|
Overall Study
Missed visits due to new work schedule
|
1
|
0
|
Baseline Characteristics
Some participants did not have a baseline WI-NRS assessment.
Baseline characteristics by cohort
| Measure |
Roflumilast Foam 0.3%
n=304 Participants
Participants with seborrheic dermatitis applied roflumilast foam 0.3% once daily (QD) for 8 weeks.
|
Vehicle Foam
n=153 Participants
Participants with seborrheic dermatitis applied vehicle foam QD for 8 weeks.
|
Total
n=457 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.2 years
STANDARD_DEVIATION 16.81 • n=304 Participants
|
41.8 years
STANDARD_DEVIATION 17.47 • n=153 Participants
|
42.7 years
STANDARD_DEVIATION 17.03 • n=457 Participants
|
|
Sex: Female, Male
Female
|
151 Participants
n=304 Participants
|
78 Participants
n=153 Participants
|
229 Participants
n=457 Participants
|
|
Sex: Female, Male
Male
|
153 Participants
n=304 Participants
|
75 Participants
n=153 Participants
|
228 Participants
n=457 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
69 Participants
n=304 Participants
|
28 Participants
n=153 Participants
|
97 Participants
n=457 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
235 Participants
n=304 Participants
|
125 Participants
n=153 Participants
|
360 Participants
n=457 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=304 Participants
|
0 Participants
n=153 Participants
|
0 Participants
n=457 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
4 Participants
n=304 Participants
|
0 Participants
n=153 Participants
|
4 Participants
n=457 Participants
|
|
Race/Ethnicity, Customized
Asian
|
18 Participants
n=304 Participants
|
10 Participants
n=153 Participants
|
28 Participants
n=457 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=304 Participants
|
1 Participants
n=153 Participants
|
1 Participants
n=457 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
36 Participants
n=304 Participants
|
15 Participants
n=153 Participants
|
51 Participants
n=457 Participants
|
|
Race/Ethnicity, Customized
White
|
234 Participants
n=304 Participants
|
122 Participants
n=153 Participants
|
356 Participants
n=457 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
1 Participants
n=304 Participants
|
1 Participants
n=153 Participants
|
2 Participants
n=457 Participants
|
|
Race/Ethnicity, Customized
Other
|
11 Participants
n=304 Participants
|
4 Participants
n=153 Participants
|
15 Participants
n=457 Participants
|
|
Investigator Global Assessment (IGA) Baseline Score
2 - Mild
|
0 Participants
n=304 Participants
|
0 Participants
n=153 Participants
|
0 Participants
n=457 Participants
|
|
Investigator Global Assessment (IGA) Baseline Score
3 - Moderate
|
287 Participants
n=304 Participants
|
141 Participants
n=153 Participants
|
428 Participants
n=457 Participants
|
|
Investigator Global Assessment (IGA) Baseline Score
4 - Severe
|
17 Participants
n=304 Participants
|
12 Participants
n=153 Participants
|
29 Participants
n=457 Participants
|
|
Worst Itch Numerical Rating Scale (WI-NRS) Baseline Score
0
|
20 Participants
n=297 Participants • Some participants did not have a baseline WI-NRS assessment.
|
9 Participants
n=152 Participants • Some participants did not have a baseline WI-NRS assessment.
|
29 Participants
n=449 Participants • Some participants did not have a baseline WI-NRS assessment.
|
|
Worst Itch Numerical Rating Scale (WI-NRS) Baseline Score
1
|
13 Participants
n=297 Participants • Some participants did not have a baseline WI-NRS assessment.
|
14 Participants
n=152 Participants • Some participants did not have a baseline WI-NRS assessment.
|
27 Participants
n=449 Participants • Some participants did not have a baseline WI-NRS assessment.
|
|
Worst Itch Numerical Rating Scale (WI-NRS) Baseline Score
2
|
22 Participants
n=297 Participants • Some participants did not have a baseline WI-NRS assessment.
|
10 Participants
n=152 Participants • Some participants did not have a baseline WI-NRS assessment.
|
32 Participants
n=449 Participants • Some participants did not have a baseline WI-NRS assessment.
|
|
Worst Itch Numerical Rating Scale (WI-NRS) Baseline Score
3
|
35 Participants
n=297 Participants • Some participants did not have a baseline WI-NRS assessment.
|
16 Participants
n=152 Participants • Some participants did not have a baseline WI-NRS assessment.
|
51 Participants
n=449 Participants • Some participants did not have a baseline WI-NRS assessment.
|
|
Worst Itch Numerical Rating Scale (WI-NRS) Baseline Score
4
|
26 Participants
n=297 Participants • Some participants did not have a baseline WI-NRS assessment.
|
15 Participants
n=152 Participants • Some participants did not have a baseline WI-NRS assessment.
|
41 Participants
n=449 Participants • Some participants did not have a baseline WI-NRS assessment.
|
|
Worst Itch Numerical Rating Scale (WI-NRS) Baseline Score
5
|
43 Participants
n=297 Participants • Some participants did not have a baseline WI-NRS assessment.
|
20 Participants
n=152 Participants • Some participants did not have a baseline WI-NRS assessment.
|
63 Participants
n=449 Participants • Some participants did not have a baseline WI-NRS assessment.
|
|
Worst Itch Numerical Rating Scale (WI-NRS) Baseline Score
6
|
40 Participants
n=297 Participants • Some participants did not have a baseline WI-NRS assessment.
|
22 Participants
n=152 Participants • Some participants did not have a baseline WI-NRS assessment.
|
62 Participants
n=449 Participants • Some participants did not have a baseline WI-NRS assessment.
|
|
Worst Itch Numerical Rating Scale (WI-NRS) Baseline Score
7
|
39 Participants
n=297 Participants • Some participants did not have a baseline WI-NRS assessment.
|
17 Participants
n=152 Participants • Some participants did not have a baseline WI-NRS assessment.
|
56 Participants
n=449 Participants • Some participants did not have a baseline WI-NRS assessment.
|
|
Worst Itch Numerical Rating Scale (WI-NRS) Baseline Score
8
|
33 Participants
n=297 Participants • Some participants did not have a baseline WI-NRS assessment.
|
16 Participants
n=152 Participants • Some participants did not have a baseline WI-NRS assessment.
|
49 Participants
n=449 Participants • Some participants did not have a baseline WI-NRS assessment.
|
|
Worst Itch Numerical Rating Scale (WI-NRS) Baseline Score
9
|
14 Participants
n=297 Participants • Some participants did not have a baseline WI-NRS assessment.
|
7 Participants
n=152 Participants • Some participants did not have a baseline WI-NRS assessment.
|
21 Participants
n=449 Participants • Some participants did not have a baseline WI-NRS assessment.
|
|
Worst Itch Numerical Rating Scale (WI-NRS) Baseline Score
10
|
12 Participants
n=297 Participants • Some participants did not have a baseline WI-NRS assessment.
|
6 Participants
n=152 Participants • Some participants did not have a baseline WI-NRS assessment.
|
18 Participants
n=449 Participants • Some participants did not have a baseline WI-NRS assessment.
|
PRIMARY outcome
Timeframe: Week 8Population: All randomized participants are included.
The percentage of participants achieving IGA "success" is presented. Success is defined as a score of 0 ('clear') or 1 ('almost clear') plus a 2-point improvement at Week 8. The IGA is 5-point scale assessing the severity of seborrheic dermatitis with total scores ranging from 0 ('clear') to 4 ('severe') \[higher scores indicating greater severity\].
Outcome measures
| Measure |
Roflumilast Foam 0.3%
n=304 Participants
Participants with seborrheic dermatitis applied roflumilast foam 0.3% once daily (QD) for 8 weeks.
|
Vehicle Foam
n=153 Participants
Participants with seborrheic dermatitis applied vehicle foam QD for 8 weeks.
|
|---|---|---|
|
Achievement of Success on the Investigator Global Assessment (IGA) at Week 8
|
80 percentage of participants
Interval 74.0 to 84.0
|
58 percentage of participants
Interval 50.0 to 66.0
|
SECONDARY outcome
Timeframe: Week 8Population: All randomized participants with a weekly baseline average WI-NRS score ≥4 are included.
The percentage of participants achieving WI-NRS "success" is presented. The WI-NRS is a simple, single-item scale to assess the participant-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the participants experienced in the previous 24 hours (higher scores indicate higher itch severity). The endpoint is the average of daily assessments reported during each study week, and requires at least 4 daily assessments reported during the week. In participants with a weekly average baseline pruritus score of ≥4, "success" is defined as achievement of a ≥4-point improvement from baseline in weekly average WI-NRS pruritus score at Week 8.
Outcome measures
| Measure |
Roflumilast Foam 0.3%
n=206 Participants
Participants with seborrheic dermatitis applied roflumilast foam 0.3% once daily (QD) for 8 weeks.
|
Vehicle Foam
n=98 Participants
Participants with seborrheic dermatitis applied vehicle foam QD for 8 weeks.
|
|---|---|---|
|
Achievement of Success in the Worst Itch Numeric Rating Scale (WI-NRS) at Week 8
|
63 percentage of participants
Interval 56.0 to 70.0
|
41 percentage of participants
Interval 31.0 to 51.0
|
SECONDARY outcome
Timeframe: Week 4Population: All randomized participants with a weekly baseline average WI-NRS score ≥4 are included.
The percentage of participants achieving WI-NRS "success" is presented. The WI-NRS is a simple, single-item scale to assess the participant-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the participants experienced in the previous 24 hours (higher scores indicate higher itch severity). The endpoint is the average of daily assessments reported during each study week, and requires at least 4 daily assessments reported during the week. In participants with a weekly average baseline pruritus score of ≥4, "success" is defined as achievement of a ≥4-point improvement from baseline in weekly average WI-NRS pruritus score at Week 4.
Outcome measures
| Measure |
Roflumilast Foam 0.3%
n=206 Participants
Participants with seborrheic dermatitis applied roflumilast foam 0.3% once daily (QD) for 8 weeks.
|
Vehicle Foam
n=98 Participants
Participants with seborrheic dermatitis applied vehicle foam QD for 8 weeks.
|
|---|---|---|
|
Achievement of Success in the WI-NRS at Week 4
|
48 percentage of participants
Interval 41.0 to 54.0
|
29 percentage of participants
Interval 21.0 to 39.0
|
SECONDARY outcome
Timeframe: Week 2Population: All randomized participants with a weekly baseline average WI-NRS score ≥4 are included.
The percentage of participants achieving WI-NRS "success" is presented. In participants with a weekly average baseline pruritus score of ≥4, "success" is defined as achievement of a ≥4-point improvement from baseline in weekly average WI-NRS pruritus score at Week 2. The endpoint is the average of daily assessments reported during each study week, and requires at least 4 daily assessments reported during the week. The WI-NRS is a simple, single-item scale to assess the participant-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the participants experienced in the previous 24 hours (higher scores indicate higher itch severity).
Outcome measures
| Measure |
Roflumilast Foam 0.3%
n=206 Participants
Participants with seborrheic dermatitis applied roflumilast foam 0.3% once daily (QD) for 8 weeks.
|
Vehicle Foam
n=98 Participants
Participants with seborrheic dermatitis applied vehicle foam QD for 8 weeks.
|
|---|---|---|
|
Achievement of Success in the WI-NRS at Week 2
|
33 percentage of participants
Interval 27.0 to 40.0
|
16 percentage of participants
Interval 10.0 to 24.0
|
SECONDARY outcome
Timeframe: Week 2Population: All randomized participants are included.
The percentage of participants achieving WI-NRS "success" is presented. The WI-NRS is a simple, single-item scale to assess the participant-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the participants experienced in the previous 24 hours (higher scores indicate higher itch severity). The endpoint is the average of daily assessments reported during each study week, and requires at least 4 daily assessments reported during the week. In participants with a weekly average baseline pruritus score of ≥4, "success" is defined as achievement of a ≥4-point improvement from baseline in weekly average WI-NRS pruritus score at Week 2.
Outcome measures
| Measure |
Roflumilast Foam 0.3%
n=304 Participants
Participants with seborrheic dermatitis applied roflumilast foam 0.3% once daily (QD) for 8 weeks.
|
Vehicle Foam
n=153 Participants
Participants with seborrheic dermatitis applied vehicle foam QD for 8 weeks.
|
|---|---|---|
|
Achievement of Success on the IGA at Week 2
|
43 percentage of participants
Interval 37.0 to 49.0
|
26 percentage of participants
Interval 19.0 to 33.0
|
SECONDARY outcome
Timeframe: Week 4Population: All randomized participants are included.
The percentage of participants achieving IGA "success" is presented. Success is defined as a score of 0 ('clear') or 1 ('almost clear') plus a 2-point improvement at Week 8. The IGA is 5-point scale assessing the severity of seborrheic dermatitis with total scores ranging from 0 ('clear') to 4 ('severe') \[higher scores indicating greater severity\].
Outcome measures
| Measure |
Roflumilast Foam 0.3%
n=304 Participants
Participants with seborrheic dermatitis applied roflumilast foam 0.3% once daily (QD) for 8 weeks.
|
Vehicle Foam
n=153 Participants
Participants with seborrheic dermatitis applied vehicle foam QD for 8 weeks.
|
|---|---|---|
|
Achievement of Success on the IGA at Week 4
|
73.1 percentage of participants
Interval 67.67 to 77.83
|
47.1 percentage of participants
Interval 39.19 to 55.1
|
SECONDARY outcome
Timeframe: Week 8Population: All randomized participants are included.
The percentage of participants achieving Overall Assessment of Scaling score of 0 at Week 8 is presented. 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 symptom severity.
Outcome measures
| Measure |
Roflumilast Foam 0.3%
n=304 Participants
Participants with seborrheic dermatitis applied roflumilast foam 0.3% once daily (QD) for 8 weeks.
|
Vehicle Foam
n=153 Participants
Participants with seborrheic dermatitis applied vehicle foam QD for 8 weeks.
|
|---|---|---|
|
Achievement of Overall Assessment of Scaling Score of 0 at Week 8
|
58 percentage of participants
Interval 52.0 to 63.0
|
37 percentage of participants
Interval 29.0 to 45.0
|
SECONDARY outcome
Timeframe: Week 8Population: All randomized participants are included.
The percentage of participants achieving Overall Assessment of Erythema score of 0 at Week 8 is presented. 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=304 Participants
Participants with seborrheic dermatitis applied roflumilast foam 0.3% once daily (QD) for 8 weeks.
|
Vehicle Foam
n=153 Participants
Participants with seborrheic dermatitis applied vehicle foam QD for 8 weeks.
|
|---|---|---|
|
Achievement of Overall Assessment of Erythema Score of 0 at Week 8
|
58 percentage of participants
Interval 52.0 to 63.0
|
32 percentage of participants
Interval 25.0 to 40.0
|
Adverse Events
Roflumilast Foam 0.3%
Vehicle Foam
Serious adverse events
| Measure |
Roflumilast Foam 0.3%
n=304 participants at risk
Participants with seborrheic dermatitis applied roflumilast foam 0.3% once daily (QD) for 8 weeks.
|
Vehicle Foam
n=153 participants at risk
Participants with seborrheic dermatitis applied vehicle foam QD for 8 weeks.
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Keratoacanthoma
|
0.33%
1/304 • Up to ~8 weeks
All randomized participants are included.
|
0.00%
0/153 • Up to ~8 weeks
All randomized participants are included.
|
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