Trial Outcomes & Findings for Safety and Efficacy of ARQ-151 Cream in Adolescents and Adults With Atopic Dermatitis (NCT NCT03916081)

Last Updated: 2023-02-13

Results Overview

The least squares (LS) mean (SD) change from baseline in EASI Total Score at Week 4 is reported. The EASI is an instrument to measure the severity and extent of AD. The body is first divided into 4 areas: head (10% of skin), arms (20%), trunk (30%), and legs (40%). Then, the area affected is scored from 0 (0% involvement) to 6 (90-100% involvement), and severity is scored from 0 ('none') to 3 ('severe'). The EASI combines the area affected and severity ratings to get a final composite score ranging from 0 (no disease) to 72 (maximal disease). Note that palms and soles were treated as appropriate but were not counted towards any measurements of EASI.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

136 participants

Primary outcome timeframe

Baseline and Week 4

Results posted on

2023-02-13

Participant Flow

Adolescent (12 to 17 years of age) and adult (≥18 years of age) male and female participants with mild to moderate atopic dermatitis (AD) were enrolled at 3 study sites in Canada and 19 sites in the US.

Participant milestones

Participant milestones
Measure	Roflumilast Cream 0.05% Participants apply roflumilast cream 0.05% QD for 28 days. Roflumilast Cream 0.05%: Roflumilast 0.05% cream for topical application	Roflumilast Cream 0.15% Participants apply roflumilast cream 0.15% QD for 28 days. Roflumilast Cream 0.15%: Roflumilast 0.15% cream for topical application	Vehicle Cream Participants apply vehicle cream QD for 28 days. Vehicle Cream: Inactive vehicle cream matched to roflumilast cream for topical application.
Overall Study STARTED	46	45	45
Overall Study COMPLETED	42	44	42
Overall Study NOT COMPLETED	4	1	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Roflumilast Cream 0.05% Participants apply roflumilast cream 0.05% QD for 28 days. Roflumilast Cream 0.05%: Roflumilast 0.05% cream for topical application	Roflumilast Cream 0.15% Participants apply roflumilast cream 0.15% QD for 28 days. Roflumilast Cream 0.15%: Roflumilast 0.15% cream for topical application	Vehicle Cream Participants apply vehicle cream QD for 28 days. Vehicle Cream: Inactive vehicle cream matched to roflumilast cream for topical application.
Overall Study Adverse Event	1	0	0
Overall Study Physician Decision	0	0	1
Overall Study Lost to Follow-up	0	1	0
Overall Study Withdrawal by Subject	3	0	1
Overall Study Worsening of AD	0	0	1

Baseline Characteristics

Safety and Efficacy of ARQ-151 Cream in Adolescents and Adults With Atopic Dermatitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Roflumilast Cream 0.05% n=46 Participants Participants apply roflumilast cream 0.05% QD for 28 days. Roflumilast Cream 0.05%: Roflumilast 0.05% cream for topical application	Roflumilast Cream 0.15% n=45 Participants Participants apply roflumilast cream 0.15% QD for 28 days. Roflumilast Cream 0.15%: Roflumilast 0.15% cream for topical application	Vehicle Cream n=45 Participants Participants apply vehicle cream QD for 28 days. Vehicle Cream: Inactive vehicle cream matched to roflumilast cream for topical application.	Total n=136 Participants Total of all reporting groups
Age, Continuous	44.3 years STANDARD_DEVIATION 16.98 • n=5 Participants	38.0 years STANDARD_DEVIATION 16.46 • n=7 Participants	42.4 years STANDARD_DEVIATION 17.64 • n=5 Participants	41.6 years STANDARD_DEVIATION 17.11 • n=4 Participants
Sex: Female, Male Female	31 Participants n=5 Participants	33 Participants n=7 Participants	29 Participants n=5 Participants	93 Participants n=4 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	12 Participants n=7 Participants	16 Participants n=5 Participants	43 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=5 Participants	10 Participants n=7 Participants	13 Participants n=5 Participants	32 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	36 Participants n=5 Participants	35 Participants n=7 Participants	32 Participants n=5 Participants	103 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	5 Participants n=7 Participants	2 Participants n=5 Participants	8 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	11 Participants n=5 Participants	14 Participants n=7 Participants	11 Participants n=5 Participants	36 Participants n=4 Participants
Race (NIH/OMB) White	32 Participants n=5 Participants	24 Participants n=7 Participants	32 Participants n=5 Participants	88 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Baseline Eczema Area and Severity Index (EASI) Score	8.44 score on a scale STANDARD_DEVIATION 4.149 • n=5 Participants	9.50 score on a scale STANDARD_DEVIATION 4.097 • n=7 Participants	9.20 score on a scale STANDARD_DEVIATION 3.877 • n=5 Participants	9.04 score on a scale STANDARD_DEVIATION 4.039 • n=4 Participants
Baseline Body Surface Area (BSA) Score	8.4 percentage of body surface area STANDARD_DEVIATION 7.11 • n=5 Participants	9.6 percentage of body surface area STANDARD_DEVIATION 5.99 • n=7 Participants	10.5 percentage of body surface area STANDARD_DEVIATION 6.62 • n=5 Participants	9.5 percentage of body surface area STANDARD_DEVIATION 6.60 • n=4 Participants
Baseline Worst Itch Numerical Rating Scale (WI-NRS) Score	6.48 score on a scale STANDARD_DEVIATION 1.986 • n=5 Participants	6.60 score on a scale STANDARD_DEVIATION 2.049 • n=7 Participants	7.20 score on a scale STANDARD_DEVIATION 2.106 • n=5 Participants	6.76 score on a scale STANDARD_DEVIATION 2.057 • n=4 Participants

PRIMARY outcome

Timeframe: Baseline and Week 4

Population: All randomized participants with data are included.

Outcome measures

Outcome measures
Measure	Roflumilast Cream 0.05% n=42 Participants Participants apply roflumilast cream 0.05% QD for 28 days. Roflumilast Cream 0.05%: Roflumilast 0.05% cream for topical application	Roflumilast Cream 0.15% n=44 Participants Participants apply roflumilast cream 0.15% QD for 28 days. Roflumilast Cream 0.15%: Roflumilast 0.15% cream for topical application	Vehicle Cream n=44 Participants Participants apply vehicle cream QD for 28 days. Vehicle Cream: Inactive vehicle cream matched to roflumilast cream for topical application.
Mean Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 4	-6.03 score on a scale Standard Deviation 0.503	-6.44 score on a scale Standard Deviation 0.492	-4.84 score on a scale Standard Deviation 0.492

SECONDARY outcome

Timeframe: Baseline and Weeks 1, 2, and 4

Population: All randomized participants with data are included.

The LS mean (SD) percentage change from baseline in EASI Total Score at Weeks 1, 2, and 4 is reported. The EASI is an instrument to measure the severity and extent of AD. The body is first divided into 4 areas: head (10% of skin), arms (20%), trunk (30%), and legs (40%). Then, the area affected is scored from 0 (0% involvement) to 6 (90-100% involvement), and severity is scored from 0 ('none') to 3 ('severe'). The EASI combines the area affected and severity ratings to get a final composite score ranging from 0 (no disease) to 72 (maximal disease). Note that palms and soles were treated as appropriate but were not counted towards any measurements of EASI.

Outcome measures

Outcome measures
Measure	Roflumilast Cream 0.05% n=46 Participants Participants apply roflumilast cream 0.05% QD for 28 days. Roflumilast Cream 0.05%: Roflumilast 0.05% cream for topical application	Roflumilast Cream 0.15% n=45 Participants Participants apply roflumilast cream 0.15% QD for 28 days. Roflumilast Cream 0.15%: Roflumilast 0.15% cream for topical application	Vehicle Cream n=45 Participants Participants apply vehicle cream QD for 28 days. Vehicle Cream: Inactive vehicle cream matched to roflumilast cream for topical application.
Percentage Change From Baseline in EASI Total Score Week 1	-35.77 percent change Standard Deviation 4.297	-34.67 percent change Standard Deviation 4.273	-24.39 percent change Standard Deviation 4.279
Percentage Change From Baseline in EASI Total Score Week 2	-54.30 percent change Standard Deviation 4.663	-57.65 percent change Standard Deviation 4.567	-48.48 percent change Standard Deviation 4.571
Percentage Change From Baseline in EASI Total Score Week 4	-69.37 percent change Standard Deviation 4.643	-72.32 percent change Standard Deviation 4.546	-55.84 percent change Standard Deviation 4.551

SECONDARY outcome

Timeframe: Baseline and Weeks 1 and 2

Population: All randomized participants with data are included.

The LS mean (SD) change from baseline in EASI Total Score at Weeks 1 and 2 is reported. The EASI is an instrument to measure the severity and extent of AD. The body is first divided into 4 areas: head (10% of skin), arms (20%), trunk (30%), and legs (40%). Then, the area affected is scored from 0 (0% involvement) to 6 (90-100% involvement), and severity is scored from 0 ('none') to 3 ('severe'). The EASI combines the area affected and severity ratings to get a final composite score ranging from 0 (no disease) to 72 (maximal disease). Note that palms and soles were treated as appropriate but were not counted towards any measurements of EASI.

Outcome measures

Outcome measures
Measure	Roflumilast Cream 0.05% n=46 Participants Participants apply roflumilast cream 0.05% QD for 28 days. Roflumilast Cream 0.05%: Roflumilast 0.05% cream for topical application	Roflumilast Cream 0.15% n=45 Participants Participants apply roflumilast cream 0.15% QD for 28 days. Roflumilast Cream 0.15%: Roflumilast 0.15% cream for topical application	Vehicle Cream n=45 Participants Participants apply vehicle cream QD for 28 days. Vehicle Cream: Inactive vehicle cream matched to roflumilast cream for topical application.
Mean Change From Baseline in EASI Total Score at Weeks 1 and 2 Week 1	-3.11 score on a scale Standard Deviation 0.416	-2.77 score on a scale Standard Deviation 0.57	-2.19 score on a scale Standard Deviation 0.414
Mean Change From Baseline in EASI Total Score at Weeks 1 and 2 Week 2	-4.80 score on a scale Standard Deviation 0.479	-5.02 score on a scale Standard Deviation 0.469	-4.31 score on a scale Standard Deviation 0.470

SECONDARY outcome

Timeframe: Baseline and Weeks 1, 2, and 4

Population: All randomized participants with ≥1 post-baseline assessment are included (last observation carried forward \[LOCF\] used for missing data after Week 1).

The number of participants with a decrease of at least 50% from the baseline EASI total score is presented. The EASI is an instrument to measure the severity and extent of AD. The body is first divided into 4 areas: head (10% of skin), arms (20%), trunk (30%), and legs (40%). Then, the area affected is scored from 0 (0% involvement) to 6 (90-100% involvement), and severity is scored from 0 ('none') to 3 ('severe'). The EASI combines the area affected and severity ratings to get a final composite score ranging from 0 (no disease) to 72 (maximal disease), with positive results indicating an increase from baseline in EASI total score (i.e., increased symptoms) and negative results indicating a decrease from baseline score (i.e., decreased symptoms). Note that palms and soles were treated as appropriate but were not counted towards any measurements of EASI.

Outcome measures

Outcome measures
Measure	Roflumilast Cream 0.05% n=46 Participants Participants apply roflumilast cream 0.05% QD for 28 days. Roflumilast Cream 0.05%: Roflumilast 0.05% cream for topical application	Roflumilast Cream 0.15% n=45 Participants Participants apply roflumilast cream 0.15% QD for 28 days. Roflumilast Cream 0.15%: Roflumilast 0.15% cream for topical application	Vehicle Cream n=45 Participants Participants apply vehicle cream QD for 28 days. Vehicle Cream: Inactive vehicle cream matched to roflumilast cream for topical application.
Number of Participants Achieving a 50% Decrease From Baseline in EASI Score (EASI-50) Week 1	14 Participants	11 Participants	10 Participants
Number of Participants Achieving a 50% Decrease From Baseline in EASI Score (EASI-50) Week 2	27 Participants	23 Participants	22 Participants
Number of Participants Achieving a 50% Decrease From Baseline in EASI Score (EASI-50) Week 4	32 Participants	33 Participants	25 Participants

SECONDARY outcome

Timeframe: Baseline and Weeks 1, 2, and 4

Population: All randomized participants with ≥1 post-baseline assessment are included (LOCF used for missing data after Week 1).

The number of participants with a decrease of at least 75% from the baseline EASI total score is presented. The EASI is an instrument to measure the severity and extent of AD. The body is first divided into 4 areas: head (10% of skin), arms (20%), trunk (30%), and legs (40%). Then, the area affected is scored from 0 (0% involvement) to 6 (90-100% involvement), and severity is scored from 0 ('none') to 3 ('severe'). The EASI combines the area affected and severity ratings to get a final composite score ranging from 0 (no disease) to 72 (maximal disease), with positive results indicating an increase from baseline in EASI total score (i.e., increased symptoms) and negative results indicating a decrease from baseline score (i.e., decreased symptoms). Note that palms and soles were treated as appropriate but were not counted towards any measurements of EASI.

Outcome measures

Outcome measures
Measure	Roflumilast Cream 0.05% n=46 Participants Participants apply roflumilast cream 0.05% QD for 28 days. Roflumilast Cream 0.05%: Roflumilast 0.05% cream for topical application	Roflumilast Cream 0.15% n=45 Participants Participants apply roflumilast cream 0.15% QD for 28 days. Roflumilast Cream 0.15%: Roflumilast 0.15% cream for topical application	Vehicle Cream n=45 Participants Participants apply vehicle cream QD for 28 days. Vehicle Cream: Inactive vehicle cream matched to roflumilast cream for topical application.
Number of Participants Achieving a 75% Decrease From Baseline in EASI Score (EASI-75) Week 1	4 Participants	6 Participants	1 Participants
Number of Participants Achieving a 75% Decrease From Baseline in EASI Score (EASI-75) Week 2	8 Participants	14 Participants	11 Participants
Number of Participants Achieving a 75% Decrease From Baseline in EASI Score (EASI-75) Week 4	26 Participants	23 Participants	14 Participants

SECONDARY outcome

Timeframe: Baseline and Weeks 1, 2, and 4

Population: All randomized participants with ≥1 post-baseline assessment are included (LOCF used for missing data after Week 1).

The number of participants with a decrease of at least 90% from the baseline EASI total score is presented. The EASI is an instrument to measure the severity and extent of AD. The body is first divided into 4 areas: head (10% of skin), arms (20%), trunk (30%), and legs (40%). Then, the area affected is scored from 0 (0% involvement) to 6 (90-100% involvement), and severity is scored from 0 ('none') to 3 ('severe'). The EASI combines the area affected and severity ratings to get a final composite score ranging from 0 (no disease) to 72 (maximal disease), with positive results indicating an increase from baseline in EASI total score (i.e., increased symptoms) and negative results indicating a decrease from baseline score (i.e., decreased symptoms). Note that palms and soles were treated as appropriate but were not counted towards any measurements of EASI. In some instances, it was not possible to compare roflumilast to vehicle due to low number of cases.

Outcome measures

Outcome measures
Measure	Roflumilast Cream 0.05% n=46 Participants Participants apply roflumilast cream 0.05% QD for 28 days. Roflumilast Cream 0.05%: Roflumilast 0.05% cream for topical application	Roflumilast Cream 0.15% n=45 Participants Participants apply roflumilast cream 0.15% QD for 28 days. Roflumilast Cream 0.15%: Roflumilast 0.15% cream for topical application	Vehicle Cream n=45 Participants Participants apply vehicle cream QD for 28 days. Vehicle Cream: Inactive vehicle cream matched to roflumilast cream for topical application.
Number of Participants Achieving a 90% Decrease From Baseline in EASI Score (EASI-90) Week 1	0 Participants	1 Participants	0 Participants
Number of Participants Achieving a 90% Decrease From Baseline in EASI Score (EASI-90) Week 2	1 Participants	6 Participants	4 Participants
Number of Participants Achieving a 90% Decrease From Baseline in EASI Score (EASI-90) Week 4	8 Participants	12 Participants	8 Participants

SECONDARY outcome

Timeframe: Baseline and Weeks 1, 2, and 4

Population: All randomized participants with ≥1 post-baseline assessment are included (LOCF used for missing data after Week 1).

The number of participants with a decrease of 100% from the baseline EASI total score is presented. The EASI is an instrument to measure the severity and extent of AD. The body is first divided into 4 areas: head (10% of skin), arms (20%), trunk (30%), and legs (40%). Then, the area affected is scored from 0 (0% involvement) to 6 (90-100% involvement), and severity is scored from 0 ('none') to 3 ('severe'). The EASI combines the area affected and severity ratings to get a final composite score ranging from 0 (no disease) to 72 (maximal disease), with positive results indicating an increase from baseline in EASI total score (i.e., increased symptoms) and negative results indicating a decrease from baseline score (i.e., decreased symptoms). Note that palms and soles were treated as appropriate but were not counted towards any measurements of EASI. In some instances, it was not possible to compare roflumilast to vehicle due to low number of cases.

Outcome measures

Outcome measures
Measure	Roflumilast Cream 0.05% n=46 Participants Participants apply roflumilast cream 0.05% QD for 28 days. Roflumilast Cream 0.05%: Roflumilast 0.05% cream for topical application	Roflumilast Cream 0.15% n=45 Participants Participants apply roflumilast cream 0.15% QD for 28 days. Roflumilast Cream 0.15%: Roflumilast 0.15% cream for topical application	Vehicle Cream n=45 Participants Participants apply vehicle cream QD for 28 days. Vehicle Cream: Inactive vehicle cream matched to roflumilast cream for topical application.
Number of Participants Achieving a 100% Decrease From Baseline in EASI Score (EASI-100) Week 1	0 Participants	0 Participants	0 Participants
Number of Participants Achieving a 100% Decrease From Baseline in EASI Score (EASI-100) Week 2	1 Participants	2 Participants	0 Participants
Number of Participants Achieving a 100% Decrease From Baseline in EASI Score (EASI-100) Week 4	1 Participants	5 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline and Weeks 1, 2, and 4

Population: All randomized participants with data are included.

The LS mean (SE) change from baseline in BSA involvement at Weeks 1, 2, and 4 is presented. The BSA affected by AD was determined by the subject's hand method, where the subject's hand (including fingers) surface area was assumed to equal 1% of BSA. Negative scores indicate improvement of symptoms, whereas positive scores indicate worsening.

Outcome measures

Outcome measures
Measure	Roflumilast Cream 0.05% n=46 Participants Participants apply roflumilast cream 0.05% QD for 28 days. Roflumilast Cream 0.05%: Roflumilast 0.05% cream for topical application	Roflumilast Cream 0.15% n=45 Participants Participants apply roflumilast cream 0.15% QD for 28 days. Roflumilast Cream 0.15%: Roflumilast 0.15% cream for topical application	Vehicle Cream n=45 Participants Participants apply vehicle cream QD for 28 days. Vehicle Cream: Inactive vehicle cream matched to roflumilast cream for topical application.
Mean Change From Baseline in Body Surface Area (BSA) Involvement Week 1	-1.19 percentage of BSA affected Standard Error 0.407	-1.67 percentage of BSA affected Standard Error 0.407	-1.57 percentage of BSA affected Standard Error 0.405
Mean Change From Baseline in Body Surface Area (BSA) Involvement Week 2	-2.69 percentage of BSA affected Standard Error 0.580	-3.63 percentage of BSA affected Standard Error 0.570	-3.29 percentage of BSA affected Standard Error 0.568
Mean Change From Baseline in Body Surface Area (BSA) Involvement Week 4	-4.41 percentage of BSA affected Standard Error 0.658	-5.10 percentage of BSA affected Standard Error 0.645	-4.16 percentage of BSA affected Standard Error 0.644

SECONDARY outcome

Timeframe: Baseline and Weeks 1, 2, and 4

Population: All randomized participants with data are included.

The LS mean (SE) change from baseline in WI-NRS score is presented. 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 symptom severity.

Outcome measures

Outcome measures
Measure	Roflumilast Cream 0.05% n=46 Participants Participants apply roflumilast cream 0.05% QD for 28 days. Roflumilast Cream 0.05%: Roflumilast 0.05% cream for topical application	Roflumilast Cream 0.15% n=45 Participants Participants apply roflumilast cream 0.15% QD for 28 days. Roflumilast Cream 0.15%: Roflumilast 0.15% cream for topical application	Vehicle Cream n=45 Participants Participants apply vehicle cream QD for 28 days. Vehicle Cream: Inactive vehicle cream matched to roflumilast cream for topical application.
Worse Itch Numerical Rating Score (WI-NRS) Score Change Week 1	-2.21 score on a scale Standard Error 2.13	-2.46 score on a scale Standard Error 0.361	-1.7 score on a scale Standard Error 2.52
Worse Itch Numerical Rating Score (WI-NRS) Score Change Week 2	-2.46 score on a scale Standard Error 0.415	-2.76 score on a scale Standard Error 0.413	-2.04 score on a scale Standard Error 0.408
Worse Itch Numerical Rating Score (WI-NRS) Score Change Week 4	-3.34 score on a scale Standard Error 0.449	-3.23 score on a scale Standard Error 0.444	-2.73 score on a scale Standard Error 0.440

SECONDARY outcome

Timeframe: Baseline and Weeks 1, 2, and 4

Population: All randomized participants with data are included.

The number of participants achieving a ≥4-point improvement from Baseline in WI-NRS score is presented. 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 symptom severity.

Outcome measures

Outcome measures
Measure	Roflumilast Cream 0.05% n=46 Participants Participants apply roflumilast cream 0.05% QD for 28 days. Roflumilast Cream 0.05%: Roflumilast 0.05% cream for topical application	Roflumilast Cream 0.15% n=45 Participants Participants apply roflumilast cream 0.15% QD for 28 days. Roflumilast Cream 0.15%: Roflumilast 0.15% cream for topical application	Vehicle Cream n=45 Participants Participants apply vehicle cream QD for 28 days. Vehicle Cream: Inactive vehicle cream matched to roflumilast cream for topical application.
Number of Participants Achieving ≥4-Point Improvement in WI-NRS Pruritus Score Week 1	11 Participants	15 Participants	9 Participants
Number of Participants Achieving ≥4-Point Improvement in WI-NRS Pruritus Score Week 2	10 Participants	15 Participants	16 Participants
Number of Participants Achieving ≥4-Point Improvement in WI-NRS Pruritus Score Week 4	21 Participants	17 Participants	18 Participants

Adverse Events

Roflumilast Cream 0.05%

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Roflumilast Cream 0.15%

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Vehicle Cream

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Roflumilast Cream 0.05% n=46 participants at risk Participants apply roflumilast cream 0.05% QD for 28 days. Roflumilast Cream 0.05%: Roflumilast 0.05% cream for topical application	Roflumilast Cream 0.15% n=45 participants at risk Participants apply roflumilast cream 0.15% QD for 28 days. Roflumilast Cream 0.15%: Roflumilast 0.15% cream for topical application	Vehicle Cream n=45 participants at risk Participants apply vehicle cream QD for 28 days. Vehicle Cream: Inactive vehicle cream matched to roflumilast cream for topical application.
Injury, poisoning and procedural complications Traumatic spinal cord compression	2.2% 1/46 • Up to 32 days All participants who received ≥1 dose of study intervention are included.	0.00% 0/45 • Up to 32 days All participants who received ≥1 dose of study intervention are included.	0.00% 0/45 • Up to 32 days All participants who received ≥1 dose of study intervention are included.

Other adverse events

Adverse event data not reported

Additional Information

Arcutis Medical Information

Arcutis Biotherapeutics

Phone: +1 (844) 692-6729

Email: [email protected]

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