Trial Outcomes & Findings for Topical Roflumilast to Treat Scalp and Body Psoriasis (ARRECTOR) (NCT NCT05028582)
NCT ID: NCT05028582
Last Updated: 2025-07-17
Results Overview
The percentage of participants with S-IGA success at Week 8 is presented. Success is defined as an IGA score of 'clear' or 'almost clear' plus a 2-point improvement from baseline at Week 8. This global assessment scale has five severity grades reported from 0-4 and defined as Clear (0), Almost Clear (1), Mild (2), Moderate (3), Severe (4), with higher scores indicative of greater symptom severity.
COMPLETED
PHASE3
432 participants
Week 8
2025-07-17
Participant Flow
Participants were enrolled at 53 study centers in the US and Canada.
Participant milestones
| Measure |
Roflumilast Foam 0.3%
Participants with plaque psoriasis of the scalp and body applied roflumilast foam 0.3% qd for 8 weeks.
|
Vehicle Foam
Participants with plaque psoriasis of the scalp and body applied vehicle foam qd for 8 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
281
|
151
|
|
Overall Study
COMPLETED
|
250
|
126
|
|
Overall Study
NOT COMPLETED
|
31
|
25
|
Reasons for withdrawal
| Measure |
Roflumilast Foam 0.3%
Participants with plaque psoriasis of the scalp and body applied roflumilast foam 0.3% qd for 8 weeks.
|
Vehicle Foam
Participants with plaque psoriasis of the scalp and body applied vehicle foam qd for 8 weeks.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
11
|
9
|
|
Overall Study
Withdrawal by Subject
|
9
|
10
|
|
Overall Study
Adverse Event
|
5
|
2
|
|
Overall Study
Miscellaneous
|
3
|
2
|
|
Overall Study
Lack of Efficacy
|
3
|
1
|
|
Overall Study
Physician Decision
|
0
|
1
|
Baseline Characteristics
Topical Roflumilast to Treat Scalp and Body Psoriasis (ARRECTOR)
Baseline characteristics by cohort
| Measure |
Roflumilast Foam 0.3%
n=281 Participants
Participants with plaque psoriasis of the scalp and body applied roflumilast foam 0.3% qd for 8 weeks.
|
Vehicle Foam
n=151 Participants
Participants with plaque psoriasis of the scalp and body applied vehicle foam qd for 8 weeks.
|
Total
n=432 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.6 years
STANDARD_DEVIATION 14.93 • n=5 Participants
|
45.0 years
STANDARD_DEVIATION 14.33 • n=7 Participants
|
47.3 years
STANDARD_DEVIATION 14.81 • n=5 Participants
|
|
Sex: Female, Male
Female
|
152 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
243 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
129 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
189 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
48 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
224 Participants
n=5 Participants
|
121 Participants
n=7 Participants
|
345 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American-Indian or Alaska Native
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
26 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African-American
|
12 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
225 Participants
n=5 Participants
|
129 Participants
n=7 Participants
|
354 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
More than One Race
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 8Population: All randomized participants are included, with multiple imputation of missing data.
The percentage of participants with S-IGA success at Week 8 is presented. Success is defined as an IGA score of 'clear' or 'almost clear' plus a 2-point improvement from baseline at Week 8. This global assessment scale has five severity grades reported from 0-4 and defined as Clear (0), Almost Clear (1), Mild (2), Moderate (3), Severe (4), with higher scores indicative of greater symptom severity.
Outcome measures
| Measure |
Roflumilast Foam 0.3%
n=281 Participants
Participants with plaque psoriasis of the scalp and body applied roflumilast foam 0.3% qd for 8 weeks.
|
Vehicle Foam
n=151 Participants
Participants with plaque psoriasis of the scalp and body applied vehicle foam qd for 8 weeks.
|
|---|---|---|
|
Achievement of Scalp Investigator Global Assessment (S-IGA) "Success" at Week 8
|
66.4 percentage of participants
Interval 59.62 to 72.56
|
27.8 percentage of participants
Interval 20.12 to 37.1
|
PRIMARY outcome
Timeframe: Week 8Population: All randomized participants are included, with multiple imputation of missing data.
The percentage of participants with B-IGA success at Week 8 is presented. Success is defined as an IGA score of 'clear' or 'almost clear' plus a 2-point improvement from baseline at Week 8. This global assessment scale has five severity grades reported from 0-4 and defined as Clear (0), Almost Clear (1), Mild (2),Moderate (3), Severe (4), with higher scores indicative of greater symptom severity.
Outcome measures
| Measure |
Roflumilast Foam 0.3%
n=281 Participants
Participants with plaque psoriasis of the scalp and body applied roflumilast foam 0.3% qd for 8 weeks.
|
Vehicle Foam
n=151 Participants
Participants with plaque psoriasis of the scalp and body applied vehicle foam qd for 8 weeks.
|
|---|---|---|
|
Achievement of Body Investigator Global Assessment (B-IGA) Success at Week 8
|
45.5 percentage of participants
Interval 38.87 to 52.33
|
20.1 percentage of participants
Interval 13.55 to 28.81
|
SECONDARY outcome
Timeframe: Week 2Population: All randomized participants with weekly average baseline SI-NRS ≥4 are included.
The percentage of participants with SI-NRS success at Week 2 is presented. Success is defined as a ≥ 4-point improvement from baseline weekly in weekly average SI-NRS in participants with weekly average baseline SI-NRS score ≥4. SI-NRS is a subject-reported severity of itch at its highest intensity during the previous 24-hour period. The scale ranges from 0 ("no itch") to 10 ("worst imaginable itch"), with higher scores indicative of greater symptom severity.
Outcome measures
| Measure |
Roflumilast Foam 0.3%
n=203 Participants
Participants with plaque psoriasis of the scalp and body applied roflumilast foam 0.3% qd for 8 weeks.
|
Vehicle Foam
n=123 Participants
Participants with plaque psoriasis of the scalp and body applied vehicle foam qd for 8 weeks.
|
|---|---|---|
|
Achievement of Scalp Itch-Numeric Rating Score (SI-NRS ) Success at Week 2
|
25.2 percentage of participants
Interval 18.96 to 32.63
|
8.0 percentage of participants
Interval 3.9 to 15.55
|
SECONDARY outcome
Timeframe: Week 4Population: All randomized participants with weekly average baseline SI-NRS ≥4 are included.
The percentage of participants with SI-NRS success at Week 4 is presented. Success is defined as a ≥ 4-point improvement from baseline weekly in weekly average SI-NRS in participants with weekly average baseline SI-NRS score ≥4. SI-NRS is a subject-reported severity of itch at its highest intensity during the previous 24-hour period. The scale ranges from 0 ("no itch") to 10 ("worst imaginable itch"), with higher scores indicative of greater symptom severity.
Outcome measures
| Measure |
Roflumilast Foam 0.3%
n=203 Participants
Participants with plaque psoriasis of the scalp and body applied roflumilast foam 0.3% qd for 8 weeks.
|
Vehicle Foam
n=123 Participants
Participants with plaque psoriasis of the scalp and body applied vehicle foam qd for 8 weeks.
|
|---|---|---|
|
Achievement of SI-NRS Success at Week 4
|
46.2 percentage of participants
Interval 38.32 to 54.22
|
16.8 percentage of participants
Interval 10.4 to 26.04
|
SECONDARY outcome
Timeframe: Week 8Population: All randomized participants with weekly average baseline SI-NRS ≥4 are included.
The percentage of participants with SI-NRS success at Week 8 is presented. Success is defined as a ≥ 4-point improvement from baseline weekly in weekly average SI-NRS in participants with weekly average baseline SI-NRS score ≥4. SI-NRS is a subject-reported severity of itch at its highest intensity during the previous 24-hour period. The scale ranges from 0 ("no itch") to 10 ("worst imaginable itch"), with higher scores indicative of greater symptom severity.
Outcome measures
| Measure |
Roflumilast Foam 0.3%
n=203 Participants
Participants with plaque psoriasis of the scalp and body applied roflumilast foam 0.3% qd for 8 weeks.
|
Vehicle Foam
n=123 Participants
Participants with plaque psoriasis of the scalp and body applied vehicle foam qd for 8 weeks.
|
|---|---|---|
|
Achievement of SI-NRS Success at Week 8
|
65.3 percentage of participants
Interval 57.26 to 72.58
|
30.3 percentage of participants
Interval 21.38 to 40.91
|
SECONDARY outcome
Timeframe: Day 1Population: All randomized participants with average, weekly SI-NRS ≥4 at baseline are included.
SI-NRS is a subject-reported severity of itch at its highest intensity during the previous 24-hour period. The scale ranges from 0 ("no itch") to 10 ("worst imaginable itch"), with higher scores indicative of greater symptom severity. A negative change from baseline indicates symptom improvement, and vice versa.
Outcome measures
| Measure |
Roflumilast Foam 0.3%
n=281 Participants
Participants with plaque psoriasis of the scalp and body applied roflumilast foam 0.3% qd for 8 weeks.
|
Vehicle Foam
n=151 Participants
Participants with plaque psoriasis of the scalp and body applied vehicle foam qd for 8 weeks.
|
|---|---|---|
|
Change From Baseline in SI-NRS Score at Day 1
|
-0.44 score on a scale
Standard Error 0.120
|
-0.09 score on a scale
Standard Error 0.149
|
SECONDARY outcome
Timeframe: Day 3Population: All randomized participants are included.
SI-NRS is a subject-reported severity of itch at its highest intensity during the previous 24-hour period. The scale ranges from 0 ("no itch") to 10 ("worst imaginable itch"), with higher scores indicative of greater symptom severity. A negative change from baseline indicates symptom improvement, and vice versa.
Outcome measures
| Measure |
Roflumilast Foam 0.3%
n=281 Participants
Participants with plaque psoriasis of the scalp and body applied roflumilast foam 0.3% qd for 8 weeks.
|
Vehicle Foam
n=151 Participants
Participants with plaque psoriasis of the scalp and body applied vehicle foam qd for 8 weeks.
|
|---|---|---|
|
Change From Baseline in SI-NRS Score at Day 3
|
-1.11 score on a scale
Standard Error 0.133
|
-0.36 score on a scale
Standard Error 0.165
|
SECONDARY outcome
Timeframe: Week 1Population: All randomized participants are included.
SI-NRS is a subject-reported severity of itch at its highest intensity during the previous 24-hour period. The scale ranges from 0 ("no itch") to 10 ("worst imaginable itch"), with higher scores indicative of greater symptom severity. A negative change from baseline indicates symptom improvement, and vice versa.
Outcome measures
| Measure |
Roflumilast Foam 0.3%
n=281 Participants
Participants with plaque psoriasis of the scalp and body applied roflumilast foam 0.3% qd for 8 weeks.
|
Vehicle Foam
n=151 Participants
Participants with plaque psoriasis of the scalp and body applied vehicle foam qd for 8 weeks.
|
|---|---|---|
|
Change From Baseline in SI-NRS Score at Week 1
|
-1.08 score on a scale
Standard Error 0.121
|
-0.53 score on a scale
Standard Error 0.151
|
SECONDARY outcome
Timeframe: Week 8Population: All randomized participants with average, weekly WI-NRS ≥4 at baseline are included.
WI-NRS is a subject-reported severity of itch at its highest intensity during the previous 24-hour period. The scale is from 0 ("no itch") to 10 ("worst imaginable itch"). Success is defined as achievement of a ≥ 4-point improvement from baseline in participants with a baseline WI-NRS pruritus score of ≥ 4.
Outcome measures
| Measure |
Roflumilast Foam 0.3%
n=203 Participants
Participants with plaque psoriasis of the scalp and body applied roflumilast foam 0.3% qd for 8 weeks.
|
Vehicle Foam
n=110 Participants
Participants with plaque psoriasis of the scalp and body applied vehicle foam qd for 8 weeks.
|
|---|---|---|
|
Achievement of WI-NRS (Worst Itch-Numeric Rating Score) Success at Week 8
|
63.1 percentage of participants
Interval 54.97 to 70.59
|
30.1 percentage of participants
Interval 20.69 to 41.44
|
SECONDARY outcome
Timeframe: Week 8Population: All randomized participants are included, with multitple imputation of missing data.
The Psoriasis Area and Severity Index (PASI) is widely used for the measurement of severity of psoriasis. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range from 0 (no disease) to 72 (maximal disease), with higher scores indicating greater symptom severity. A decrease from baseline indicates symptom improvement, and vice versa.
Outcome measures
| Measure |
Roflumilast Foam 0.3%
n=281 Participants
Participants with plaque psoriasis of the scalp and body applied roflumilast foam 0.3% qd for 8 weeks.
|
Vehicle Foam
n=151 Participants
Participants with plaque psoriasis of the scalp and body applied vehicle foam qd for 8 weeks.
|
|---|---|---|
|
Achievement of a 75% Reduction From Baseline in Psoriasis Area and Severity Index (PASI-75)
|
50.1 percentage of participants
Interval 43.24 to 56.91
|
16.8 percentage of participants
Interval 10.77 to 25.15
|
SECONDARY outcome
Timeframe: Week 8Population: All randomized participants ≥18 years of age are included.
The PSD is a 16-item questionnaire asking subjects to rate the severity of psoriasis-related symptoms in the past 24 hours. Each question is scored from 0 ("no symptoms") to 10 ("worst imaginable symptoms"). Scores range from 0 to 160, with higher scores indicating greater symptom severity. The aggregate Itching, Pain, and Scaling score ranges from 0 to 30; the change from baseline in aggregate score was assessed per protocol only in adult participants.
Outcome measures
| Measure |
Roflumilast Foam 0.3%
n=274 Participants
Participants with plaque psoriasis of the scalp and body applied roflumilast foam 0.3% qd for 8 weeks.
|
Vehicle Foam
n=148 Participants
Participants with plaque psoriasis of the scalp and body applied vehicle foam qd for 8 weeks.
|
|---|---|---|
|
Change From Baseline in Psoriasis Symptoms Diary (PSD) Aggregate Score of Itching, Pain, and Scaling (Questions 1, 9, and 11)
|
-10.87 score on a scale
Standard Error 0.546
|
-5.75 score on a scale
Standard Error 0.698
|
SECONDARY outcome
Timeframe: Week 8Population: All randomized participants ≥18 years of age are included.
The PSD is a 16-item questionnaire asking subjects to rate the severity of psoriasis-related symptoms in the past 24 hours. Each question is scored from 0 ("no symptoms") to 10 ("worst imaginable symptoms"). Scores range from 0 to 160, with higher scores indicating greater symptom severity. The Scaling score ranges from 0 to 10.
Outcome measures
| Measure |
Roflumilast Foam 0.3%
n=274 Participants
Participants with plaque psoriasis of the scalp and body applied roflumilast foam 0.3% qd for 8 weeks.
|
Vehicle Foam
n=148 Participants
Participants with plaque psoriasis of the scalp and body applied vehicle foam qd for 8 weeks.
|
|---|---|---|
|
Percentage of Participants Achieving PSD Itching (Question 1) Score of 0 at Week 8
|
31.7 percentage of participants
Interval 25.63 to 38.58
|
10.0 percentage of participants
Interval 5.55 to 17.32
|
SECONDARY outcome
Timeframe: Week 8Population: All randomized participants ≥18 years of age are included.
The PSD is a 16-item questionnaire asking subjects to rate the severity of psoriasis-related symptoms in the past 24 hours. Each question is scored from 0 ("no symptoms") to 10 ("worst imaginable symptoms"). Scores range from 0 to 160, with higher scores indicating greater symptom severity. The Pain score ranges from 0 to 10.
Outcome measures
| Measure |
Roflumilast Foam 0.3%
n=274 Participants
Participants with plaque psoriasis of the scalp and body applied roflumilast foam 0.3% qd for 8 weeks.
|
Vehicle Foam
n=148 Participants
Participants with plaque psoriasis of the scalp and body applied vehicle foam qd for 8 weeks.
|
|---|---|---|
|
Percentage of Participants Achieving PSD Pain (Question 9) Score of 0 at Week 8
|
64.9 percentage of participants
Interval 58.03 to 71.24
|
40.3 percentage of participants
Interval 31.36 to 49.95
|
SECONDARY outcome
Timeframe: Week 8Population: All randomized participants ≥18 years of age are included.
The PSD is a 16-item questionnaire asking subjects to rate the severity of psoriasis-related symptoms in the past 24 hours. Each question is scored from 0 ("no symptoms") to 10 ("worst imaginable symptoms"). Scores range from 0 to 160, with higher scores indicating greater symptom severity. The Scaling score ranges from 0 to 10.
Outcome measures
| Measure |
Roflumilast Foam 0.3%
n=274 Participants
Participants with plaque psoriasis of the scalp and body applied roflumilast foam 0.3% qd for 8 weeks.
|
Vehicle Foam
n=148 Participants
Participants with plaque psoriasis of the scalp and body applied vehicle foam qd for 8 weeks.
|
|---|---|---|
|
Percentage of Participants Achieving PSD Scaling (Question 11) Score of 0 at Week 8
|
41.5 percentage of participants
Interval 34.86 to 48.54
|
13.6 percentage of participants
Interval 8.26 to 21.59
|
SECONDARY outcome
Timeframe: Week 8Population: All randomized participants ≥18 years of age are included.
Outcome measures
| Measure |
Roflumilast Foam 0.3%
n=274 Participants
Participants with plaque psoriasis of the scalp and body applied roflumilast foam 0.3% qd for 8 weeks.
|
Vehicle Foam
n=148 Participants
Participants with plaque psoriasis of the scalp and body applied vehicle foam qd for 8 weeks.
|
|---|---|---|
|
Percentage of Participants Achieving PSD Total Score of 0 at Week 8
|
19.6 percentage of participants
Interval 14.65 to 25.82
|
7.1 percentage of participants
Interval 3.5 to 13.79
|
SECONDARY outcome
Timeframe: Week 8Population: All randomized participants are included, with multiple imputation of missing data..
The PSSI combines the assessment of the severity of scalp lesions and the area of scalp affected into a single score in the range 0 (no disease) to 72 (maximal disease). PSSI combines the assessment of the severity of scalp lesions and the area of scalp affected into a single score in the range 0 (no disease) to 72 (maximal disease).
Outcome measures
| Measure |
Roflumilast Foam 0.3%
n=281 Participants
Participants with plaque psoriasis of the scalp and body applied roflumilast foam 0.3% qd for 8 weeks.
|
Vehicle Foam
n=151 Participants
Participants with plaque psoriasis of the scalp and body applied vehicle foam qd for 8 weeks.
|
|---|---|---|
|
Achievement of a 75% Reduction From Baseline in Psoriasis Scalp Severity Index (PSSI) Score (PSSI-75)
|
70.9 percentage of participants
Interval 64.27 to 76.7
|
31.3 percentage of participants
Interval 23.15 to 40.72
|
SECONDARY outcome
Timeframe: Week 8Population: All randomized participants are included, with multiple imputation of missing data.
The percentage of participants with S-IGA score of 0 Week 8 is presented. This global assessment scale has five severity grades reported from 0-4 and defined as Clear (0), Almost Clear (1), Mild (2), Moderate (3), Severe (4), with higher scores indicative of greater symptom severity.
Outcome measures
| Measure |
Roflumilast Foam 0.3%
n=281 Participants
Participants with plaque psoriasis of the scalp and body applied roflumilast foam 0.3% qd for 8 weeks.
|
Vehicle Foam
n=151 Participants
Participants with plaque psoriasis of the scalp and body applied vehicle foam qd for 8 weeks.
|
|---|---|---|
|
Achievement of S-IGA Score of 'Clear' at Week 8
|
40.0 percentage of participants
Interval 33.47 to 46.81
|
9.1 percentage of participants
Interval 4.88 to 16.18
|
SECONDARY outcome
Timeframe: Week 2Population: All randomized participants are included, with multiple imputation of missing data.
The percentage of participants with S-IGA success at Week 2 is presented. Success is defined as an IGA score of 'clear' or 'almost clear' plus a 2-point improvement from baseline. This global assessment scale has five severity grades reported from 0-4 and defined as Clear (0), Almost Clear (1), Mild (2), Moderate (3), Severe (4), with higher scores indicative of greater symptom severity.
Outcome measures
| Measure |
Roflumilast Foam 0.3%
n=281 Participants
Participants with plaque psoriasis of the scalp and body applied roflumilast foam 0.3% qd for 8 weeks.
|
Vehicle Foam
n=151 Participants
Participants with plaque psoriasis of the scalp and body applied vehicle foam qd for 8 weeks.
|
|---|---|---|
|
Achievement of S-IGA Success at Week 2
|
30.4 percentage of participants
Interval 24.62 to 36.92
|
11.7 percentage of participants
Interval 6.9 to 19.2
|
SECONDARY outcome
Timeframe: Week 4Population: All randomized participants are included, with multiple imputation of missing data.
The percentage of participants with S-IGA success at Week 4 is presented. Success is defined as an IGA score of 'clear' or 'almost clear' plus a 2-point improvement from baseline. This global assessment scale has five severity grades reported from 0-4 and defined as Clear (0), Almost Clear (1), Mild (2), Moderate (3), Severe (4), with higher scores indicative of greater symptom severity.
Outcome measures
| Measure |
Roflumilast Foam 0.3%
n=281 Participants
Participants with plaque psoriasis of the scalp and body applied roflumilast foam 0.3% qd for 8 weeks.
|
Vehicle Foam
n=151 Participants
Participants with plaque psoriasis of the scalp and body applied vehicle foam qd for 8 weeks.
|
|---|---|---|
|
Achievement of S-IGA Success at Week 4
|
53.8 percentage of participants
Interval 47.0 to 60.46
|
19.5 percentage of participants
Interval 13.09 to 27.95
|
SECONDARY outcome
Timeframe: Week 2Population: All randomized participants are included, with multiple imputation of missing data.
The Psoriasis Area and Severity Index (PASI) is widely used for the measurement of severity of psoriasis. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range from 0 (no disease) to 72 (maximal disease), with higher scores indicating greater symptom severity. A decrease from baseline indicates symptom improvement, and vice versa.
Outcome measures
| Measure |
Roflumilast Foam 0.3%
n=281 Participants
Participants with plaque psoriasis of the scalp and body applied roflumilast foam 0.3% qd for 8 weeks.
|
Vehicle Foam
n=151 Participants
Participants with plaque psoriasis of the scalp and body applied vehicle foam qd for 8 weeks.
|
|---|---|---|
|
Change From Baseline in PASI Score at Week 2
|
-2.31 score on a scale
Standard Error 0.157
|
-1.03 score on a scale
Standard Error 0.193
|
Adverse Events
Roflumilast Foam 0.3%
Vehicle Foam
Serious adverse events
| Measure |
Roflumilast Foam 0.3%
n=281 participants at risk
Participants with plaque psoriasis of the scalp and body applied roflumilast foam 0.3% qd for 8 weeks.
|
Vehicle Foam
n=151 participants at risk
Participants with plaque psoriasis of the scalp and body applied vehicle foam qd for 8 weeks.
|
|---|---|---|
|
Psychiatric disorders
Bipolar disorder
|
0.36%
1/281 • Up to ~12 weeks (8 weeks of treatment + 4 weeks of follow-up)
All treated participants are included.
|
0.00%
0/151 • Up to ~12 weeks (8 weeks of treatment + 4 weeks of follow-up)
All treated participants are included.
|
|
Gastrointestinal disorders
Gastritis
|
0.36%
1/281 • Up to ~12 weeks (8 weeks of treatment + 4 weeks of follow-up)
All treated participants are included.
|
0.00%
0/151 • Up to ~12 weeks (8 weeks of treatment + 4 weeks of follow-up)
All treated participants are included.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/281 • Up to ~12 weeks (8 weeks of treatment + 4 weeks of follow-up)
All treated participants are included.
|
0.66%
1/151 • Up to ~12 weeks (8 weeks of treatment + 4 weeks of follow-up)
All treated participants are included.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/281 • Up to ~12 weeks (8 weeks of treatment + 4 weeks of follow-up)
All treated participants are included.
|
0.66%
1/151 • Up to ~12 weeks (8 weeks of treatment + 4 weeks of follow-up)
All treated participants are included.
|
|
Vascular disorders
Peripheral artery occlusion
|
0.00%
0/281 • Up to ~12 weeks (8 weeks of treatment + 4 weeks of follow-up)
All treated participants are included.
|
0.66%
1/151 • Up to ~12 weeks (8 weeks of treatment + 4 weeks of follow-up)
All treated 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 process of coordinating publication efforts is detailed in the Clinical Trial Agreement.
- Publication restrictions are in place
Restriction type: OTHER