Trial · NCT04973228
Trial of PDE4 Inhibition With Roflumilast (ARQ-154) Foam 0.3% for the Management of Seborrheic Dermatitis (STRATUM)
NCT04973228, Phase 3, Completed, Arcutis Biotherapeutics, Inc.; results first posted 2024-03-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Trial of PDE4 Inhibition With Roflumilast (ARQ-154) Foam 0.3% for the Management of Seborrheic Dermatitis (STRATUM). Trials, record NCT04973228. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04973228
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial of PDE4 Inhibition With Roflumilast (ARQ-154) Foam 0.3% for the Management of Seborrheic Dermatitis (STRATUM)
- NCT number
- NCT04973228
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 457 participants, actual
- Lead sponsor
- Arcutis Biotherapeutics, Inc.
- Conditions
- Seborrheic Dermatitis
- Interventions
- Roflumilast Foam, Vehicle Foam
- First posted
- 2021-07-22
- Last updated
- 2024-03-12
- Results first posted
- 2024-03-12
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Achievement of Success on the Investigator Global Assessment (IGA) at Week 8 | Week 8 | 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') \[higher scores indicating greater severity\]. |
| Secondary | Achievement of Success in the Worst Itch Numeric Rating Scale (WI-NRS) at Week 8 | Week 8 | 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. |
| Secondary | Achievement of Success in the WI-NRS at Week 4 | Week 4 | 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. |
| Secondary | Achievement of Success in the WI-NRS at Week 2 | Week 2 | 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). |
| Secondary | Achievement of Success on the IGA at Week 2 | Week 2 | 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. |
| Secondary | Achievement of Success on the IGA at Week 4 | Week 4 | 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') \[higher scores indicating greater severity\]. |
| Secondary | Achievement of Overall Assessment of Scaling Score of 0 at Week 8 | Week 8 | 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. |
| Secondary | Achievement of Overall Assessment of Erythema Score of 0 at Week 8 | Week 8 | 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. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Achievement of Success on the Investigator Global Assessment (IGA) at Week 8 | Week 8 | All randomized participants are included. | percentage of participants | NUMBER |
| SECONDARY | Achievement of Success in the Worst Itch Numeric Rating Scale (WI-NRS) at Week 8 | Week 8 | All randomized participants with a weekly baseline average WI-NRS score ≥4 are included. | percentage of participants | NUMBER |
| SECONDARY | Achievement of Success in the WI-NRS at Week 4 | Week 4 | All randomized participants with a weekly baseline average WI-NRS score ≥4 are included. | percentage of participants | NUMBER |
| SECONDARY | Achievement of Success in the WI-NRS at Week 2 | Week 2 | All randomized participants with a weekly baseline average WI-NRS score ≥4 are included. | percentage of participants | NUMBER |
| SECONDARY | Achievement of Success on the IGA at Week 2 | Week 2 | All randomized participants are included. | percentage of participants | NUMBER |
| SECONDARY | Achievement of Success on the IGA at Week 4 | Week 4 | All randomized participants are included. | percentage of participants | NUMBER |
| SECONDARY | Achievement of Overall Assessment of Scaling Score of 0 at Week 8 | Week 8 | All randomized participants are included. | percentage of participants | NUMBER |
| SECONDARY | Achievement of Overall Assessment of Erythema Score of 0 at Week 8 | Week 8 | All randomized participants are included. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Achievement of Success on the Investigator Global Assessment (IGA) at Week 8 | Roflumilast Foam 0.3% | 80 | 95% Confidence Interval 74 to 84 | percentage of participants | |
| Achievement of Success on the Investigator Global Assessment (IGA) at Week 8 | Vehicle Foam | 58 | 95% Confidence Interval 50 to 66 | percentage of participants | |
| Achievement of Success in the Worst Itch Numeric Rating Scale (WI-NRS) at Week 8 | Roflumilast Foam 0.3% | 63 | 95% Confidence Interval 56 to 70 | percentage of participants | |
| Achievement of Success in the Worst Itch Numeric Rating Scale (WI-NRS) at Week 8 | Vehicle Foam | 41 | 95% Confidence Interval 31 to 51 | percentage of participants | |
| Achievement of Success in the WI-NRS at Week 4 | Roflumilast Foam 0.3% | 48 | 95% Confidence Interval 41 to 54 | percentage of participants | |
| Achievement of Success in the WI-NRS at Week 4 | Vehicle Foam | 29 | 95% Confidence Interval 21 to 39 | percentage of participants | |
| Achievement of Success in the WI-NRS at Week 2 | Roflumilast Foam 0.3% | 33 | 95% Confidence Interval 27 to 40 | percentage of participants | |
| Achievement of Success in the WI-NRS at Week 2 | Vehicle Foam | 16 | 95% Confidence Interval 10 to 24 | percentage of participants | |
| Achievement of Success on the IGA at Week 2 | Roflumilast Foam 0.3% | 43 | 95% Confidence Interval 37 to 49 | percentage of participants | |
| Achievement of Success on the IGA at Week 2 | Vehicle Foam | 26 | 95% Confidence Interval 19 to 33 | percentage of participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 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% | 304 | |
| Overall Study | STARTED | Vehicle Foam | 153 | |
| Overall Study | COMPLETED | Roflumilast Foam 0.3% | 276 | |
| Overall Study | COMPLETED | Vehicle Foam | 138 | |
| Overall Study | NOT COMPLETED | Roflumilast Foam 0.3% | 28 | |
| Overall Study | NOT COMPLETED | Vehicle Foam | 15 |
Source ClinicalTrials.gov
Adverse events2
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 | Keratoacanthoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Roflumilast Foam 0.3% | 1 | 304 | |
| serious | Keratoacanthoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Vehicle Foam | 0 | 153 |
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 | 304 |
| Total, all-cause mortality | Vehicle Foam | 0 | 153 |
| Total, other adverse events | Roflumilast Foam 0.3% | 0 | 304 |
| Total, other adverse events | Vehicle Foam | 0 | 153 |
| Total, serious adverse events | Roflumilast Foam 0.3% | 1 | 304 |
| Total, serious adverse events | Vehicle Foam | 0 | 153 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT04973228
GET https://conductscience.org/api/trials/v1/NCT04973228/registered