Trial · NCT05028582
Topical Roflumilast to Treat Scalp and Body Psoriasis (ARRECTOR)
NCT05028582, Phase 3, Completed, Arcutis Biotherapeutics, Inc.; results first posted 2025-07-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Topical Roflumilast to Treat Scalp and Body Psoriasis (ARRECTOR). Trials, record NCT05028582. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05028582
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Topical Roflumilast to Treat Scalp and Body Psoriasis (ARRECTOR)
- NCT number
- NCT05028582
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 432 participants, actual
- Lead sponsor
- Arcutis Biotherapeutics, Inc.
- Conditions
- Scalp Psoriasis
- Interventions
- Roflumilast Foam 0.3%, Vehicle Foam
- First posted
- 2021-08-31
- Last updated
- 2025-07-17
- Results first posted
- 2025-07-17
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Achievement of Scalp Investigator Global Assessment (S-IGA) "Success" at Week 8 | Week 8 | 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. |
| Primary | Achievement of Body Investigator Global Assessment (B-IGA) Success at Week 8 | Week 8 | 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. |
| Secondary | Achievement of Scalp Itch-Numeric Rating Score (SI-NRS ) Success at Week 2 | Week 2 | 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. |
| Secondary | Achievement of SI-NRS Success at Week 4 | Week 4 | 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. |
| Secondary | Achievement of SI-NRS Success at Week 8 | Week 8 | 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. |
| Secondary | Change From Baseline in SI-NRS Score at Day 1 | Day 1 | 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. |
| Secondary | Change From Baseline in SI-NRS Score at Day 3 | Day 3 | 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. |
| Secondary | Change From Baseline in SI-NRS Score at Week 1 | Week 1 | 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. |
| Secondary | Achievement of WI-NRS (Worst Itch-Numeric Rating Score) Success at Week 8 | Week 8 | 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. |
| Secondary | Achievement of a 75% Reduction From Baseline in Psoriasis Area and Severity Index (PASI-75) | Week 8 | 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. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Achievement of Scalp Investigator Global Assessment (S-IGA) Success at Week 8 | Week 8 | All randomized participants are included, with multiple imputation of missing data. | percentage of participants | NUMBER |
| PRIMARY | Achievement of Body Investigator Global Assessment (B-IGA) Success at Week 8 | Week 8 | All randomized participants are included, with multiple imputation of missing data. | percentage of participants | NUMBER |
| SECONDARY | Achievement of Scalp Itch-Numeric Rating Score (SI-NRS ) Success at Week 2 | Week 2 | All randomized participants with weekly average baseline SI-NRS ≥4 are included. | percentage of participants | NUMBER |
| SECONDARY | Achievement of SI-NRS Success at Week 4 | Week 4 | All randomized participants with weekly average baseline SI-NRS ≥4 are included. | percentage of participants | NUMBER |
| SECONDARY | Achievement of SI-NRS Success at Week 8 | Week 8 | All randomized participants with weekly average baseline SI-NRS ≥4 are included. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in SI-NRS Score at Day 1 | Day 1 | All randomized participants with average, weekly SI-NRS ≥4 at baseline are included. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in SI-NRS Score at Day 3 | Day 3 | All randomized participants are included. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in SI-NRS Score at Week 1 | Week 1 | All randomized participants are included. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Achievement of WI-NRS (Worst Itch-Numeric Rating Score) Success at Week 8 | Week 8 | All randomized participants with average, weekly WI-NRS ≥4 at baseline are included. | percentage of participants | NUMBER |
| SECONDARY | Achievement of a 75% Reduction From Baseline in Psoriasis Area and Severity Index (PASI-75) | Week 8 | All randomized participants are included, with multitple imputation of missing data. | percentage of participants | NUMBER |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Achievement of Scalp Investigator Global Assessment (S-IGA) Success at Week 8 | Roflumilast Foam 0.3% | 66.4 | 97.5% Confidence Interval 59.62 to 72.56 | percentage of participants | |
| Achievement of Scalp Investigator Global Assessment (S-IGA) Success at Week 8 | Vehicle Foam | 27.8 | 97.5% Confidence Interval 20.12 to 37.10 | percentage of participants | |
| Achievement of Body Investigator Global Assessment (B-IGA) Success at Week 8 | Roflumilast Foam 0.3% | 45.5 | 97.5% Confidence Interval 38.87 to 52.33 | percentage of participants | |
| Achievement of Body Investigator Global Assessment (B-IGA) Success at Week 8 | Vehicle Foam | 20.1 | 97.5% Confidence Interval 13.55 to 28.81 | percentage of participants | |
| Achievement of Scalp Itch-Numeric Rating Score (SI-NRS ) Success at Week 2 | Roflumilast Foam 0.3% | 25.2 | 97.5% Confidence Interval 18.96 to 32.63 | percentage of participants | |
| Achievement of Scalp Itch-Numeric Rating Score (SI-NRS ) Success at Week 2 | Vehicle Foam | 8.0 | 97.5% Confidence Interval 3.90 to 15.55 | percentage of participants | |
| Achievement of SI-NRS Success at Week 4 | Roflumilast Foam 0.3% | 46.2 | 97.5% Confidence Interval 38.32 to 54.22 | percentage of participants | |
| Achievement of SI-NRS Success at Week 4 | Vehicle Foam | 16.8 | 97.5% Confidence Interval 10.40 to 26.04 | percentage of participants | |
| Achievement of SI-NRS Success at Week 8 | Roflumilast Foam 0.3% | 65.3 | 97.5% Confidence Interval 57.26 to 72.58 | percentage of participants | |
| Achievement of SI-NRS Success at Week 8 | Vehicle Foam | 30.3 | 97.5% Confidence Interval 21.38 to 40.91 | percentage of participants |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Roflumilast Foam 0.3% | 281 | |
| Overall Study | STARTED | Vehicle Foam | 151 | |
| Overall Study | COMPLETED | Roflumilast Foam 0.3% | 250 | |
| Overall Study | COMPLETED | Vehicle Foam | 126 | |
| Overall Study | NOT COMPLETED | Roflumilast Foam 0.3% | 31 | |
| Overall Study | NOT COMPLETED | Vehicle Foam | 25 |
Source ClinicalTrials.gov
Adverse events10
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Bipolar disorder | Psychiatric disorders | Roflumilast Foam 0.3% | 1 | 281 | |
| serious | Bipolar disorder | Psychiatric disorders | Vehicle Foam | 0 | 151 | |
| serious | Gastritis | Gastrointestinal disorders | Roflumilast Foam 0.3% | 1 | 281 | |
| serious | Gastritis | Gastrointestinal disorders | Vehicle Foam | 0 | 151 | |
| serious | Radius fracture | Injury, poisoning and procedural complications | Roflumilast Foam 0.3% | 0 | 281 | |
| serious | Radius fracture | Injury, poisoning and procedural complications | Vehicle Foam | 1 | 151 | |
| serious | Joint dislocation | Injury, poisoning and procedural complications | Roflumilast Foam 0.3% | 0 | 281 | |
| serious | Joint dislocation | Injury, poisoning and procedural complications | Vehicle Foam | 1 | 151 | |
| serious | Peripheral artery occlusion | Vascular disorders | Roflumilast Foam 0.3% | 0 | 281 | |
| serious | Peripheral artery occlusion | Vascular disorders | Vehicle Foam | 1 | 151 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Roflumilast Foam 0.3% | 0 | 281 |
| Total, all-cause mortality | Vehicle Foam | 0 | 151 |
| Total, other adverse events | Roflumilast Foam 0.3% | 0 | 281 |
| Total, other adverse events | Vehicle Foam | 0 | 151 |
| Total, serious adverse events | Roflumilast Foam 0.3% | 2 | 281 |
| Total, serious adverse events | Vehicle Foam | 1 | 151 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40332898 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Roflumilast Foam 0.3% vs Vehicle Foam: deaths from any cause | Trial comparisons |
| Roflumilast Foam 0.3% vs Vehicle Foam: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05028582
GET https://conductscience.org/api/trials/v1/NCT05028582/results?page=2