Trial · NCT04091646
Safety and Efficacy of ARQ-154 Foam in Subjects With Seborrheic Dermatitis
NCT04091646, Phase 2, Completed, Arcutis Biotherapeutics, Inc.; results first posted 2023-07-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy of ARQ-154 Foam in Subjects With Seborrheic Dermatitis. Trials, record NCT04091646. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04091646
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of ARQ-154 Foam in Subjects With Seborrheic Dermatitis
- NCT number
- NCT04091646
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 226 participants, actual
- Lead sponsor
- Arcutis Biotherapeutics, Inc.
- Conditions
- Seborrheic Dermatitis
- Interventions
- Roflumilast Foam 0.3%, Vehicle foam
- First posted
- 2019-09-17
- Last updated
- 2023-07-03
- Results first posted
- 2023-07-03
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 Investigator Global Assessment (IGA) Success at Week 8 | Week 8 | The number of participants achieving "success" in IGA assessment of disease severity at Week 8 is presented for each arm. Success was defined as achievement of an IGA score of 0 ('completely clear') or 1 ('almost clear'), accompanied by a ≥2-grade improvement from baseline IGA score. The IGA is 5-point scale assessing the severity of Seborrheic Dermatitis, with scores ranging from 0 ('completely clear') to 4 ('severe'), and higher scores indicate greater severity. The IGA scores are based on observed data, whereas odds ratio and p-values were calculated using multiple imputation of missing values. |
| Secondary | Achievement of IGA Success at Weeks 2 and 4 | Weeks 2 and 4 | The number of participants achieving "success" in IGA assessment of disease severity at Weeks 2 and 4 is presented for each arm. Success was defined as achievement of an IGA score of 0 ('completely clear') or 1 ('almost clear'), accompanied by a ≥2-grade improvement from baseline IGA score. The IGA is 5-point scale assessing the severity of Seborrheic Dermatitis, with scores ranging from 0 ('completely clear') to 4 ('severe'), and higher scores indicate greater severity. The IGA scores are based on observed data, whereas odds ratio and p-values were calculated using multiple imputation of missing values. |
| Secondary | Change From Baseline in Overall Assessment of Erythema Score | Weeks 2, 4, and 8 | The mean (SD) change from baseline in Overall Assessment of Erythema score at Weeks 2, 4, and 8 is shown. 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. |
| Secondary | Achievement of Overall Assessment of Erythema Success | Weeks 2, 4, and 8 | The number of participants achieving "success" in Overall Assessment of Erythema at Weeks 2, 4, and 8 is presented for each arm. Success was defined as achievement of an overall score of 0 or 1 plus a ≥2 grade improvement from Baseline. The Overall Assessment of Erythema 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. |
| Secondary | Change From Baseline in Overall Assessment of Scaling Score | Weeks 2, 4, and 8 | The mean (SD) change from baseline in Overall Assessment of Scaling score at Weeks 2, 4, and 8 is shown. 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 severity. |
| Secondary | Achievement of Overall Assessment of Scaling Success | Weeks 2, 4, and 8 | The number of participants achieving "success" in Overall Assessment of Scaling score at Weeks 2, 4, and 8 is presented for each arm. Success was defined as achievement of an Overall Assessment of Scaling score of 0 or 1 plus a ≥2 grade improvement from Baseline. 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 severity. |
| Secondary | Change From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Score | Weeks 2, 4, and 8 | The change from baseline in WI-NRS is shown. 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. Negative values represent a decrease in worst itch from baseline, and positive values indicate an increase. |
| Secondary | Achievement of WI-NRS Success | Weeks 2, 4, and 8 | The number of participants achieving WI-NRS "success" at Weeks 2, 4, and 8 is presented. Success was defined as achievement of a ≥4-point improvement from baseline WI-NRS score. 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. |
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 Investigator Global Assessment (IGA) Success at Week 8 | Week 8 | All randomized participants are included, with the exception of those who missed the Week 8 assessment due to COVID-19 disruption. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Achievement of IGA Success at Weeks 2 and 4 | Weeks 2 and 4 | All randomized participants are included, with the exception of those who missed the Week 8 assessment due to COVID-19 disruption. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Overall Assessment of Erythema Score | Weeks 2, 4, and 8 | All randomized participants who provided data are included, with the exception of those who missed the Week 8 assessment due to COVID-19 disruption. | score on a scale | MEAN |
| SECONDARY | Achievement of Overall Assessment of Erythema Success | Weeks 2, 4, and 8 | All randomized participants who provided data are included, with the exception of those who missed the Week 8 assessment due to COVID-19 disruption. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Overall Assessment of Scaling Score | Weeks 2, 4, and 8 | All randomized participants who provided data are included, with the exception of those who missed the Week 8 assessment due to COVID-19 disruption. | Score on a scale | MEAN |
| SECONDARY | Achievement of Overall Assessment of Scaling Success | Weeks 2, 4, and 8 | All randomized participants who provided data are included, with the exception of those who missed the Week 8 assessment due to COVID-19 disruption. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Score | Weeks 2, 4, and 8 | All randomized participants who provided data are included, with the exception of those who missed the Week 8 assessment due to COVID-19 disruption. | score on a scale | MEAN |
| SECONDARY | Achievement of WI-NRS Success | Weeks 2, 4, and 8 | All randomized participants who provided data are included, with the exception of those who missed the Week 8 assessment due to COVID-19 disruption or those with baseline WI-NRS \<4. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group42
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Achievement of Investigator Global Assessment (IGA) Success at Week 8 | Roflumilast Foam 0.3% | 104 | Participants | ||
| Achievement of Investigator Global Assessment (IGA) Success at Week 8 | Vehicle Foam | 27 | Participants | ||
| Achievement of IGA Success at Weeks 2 and 4 | Roflumilast Foam 0.3% | Week 2 | 51 | Participants | |
| Achievement of IGA Success at Weeks 2 and 4 | Vehicle Foam | Week 2 | 10 | Participants | |
| Achievement of IGA Success at Weeks 2 and 4 | Roflumilast Foam 0.3% | Week 4 | 81 | Participants | |
| Achievement of IGA Success at Weeks 2 and 4 | Vehicle Foam | Week 4 | 19 | Participants | |
| Change From Baseline in Overall Assessment of Erythema Score | Roflumilast Foam 0.3% | Week 2 | -1.0 | Standard Deviation 0.73 | score on a scale |
| Change From Baseline in Overall Assessment of Erythema Score | Vehicle Foam | Week 2 | -0.4 | Standard Deviation 0.65 | score on a scale |
| Change From Baseline in Overall Assessment of Erythema Score | Roflumilast Foam 0.3% | Week 4 | -1.3 | Standard Deviation 0.73 | score on a scale |
| Change From Baseline in Overall Assessment of Erythema Score | Vehicle Foam | Week 4 | -0.7 | Standard Deviation 0.68 | score on a scale |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 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% | 154 | |
| Overall Study | STARTED | Vehicle Foam | 72 | |
| Overall Study | COMPLETED | Roflumilast Foam 0.3% | 141 | |
| Overall Study | COMPLETED | Vehicle Foam | 67 | |
| Overall Study | NOT COMPLETED | Roflumilast Foam 0.3% | 13 | |
| Overall Study | NOT COMPLETED | Vehicle Foam | 5 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
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 | 154 |
| Total, all-cause mortality | Vehicle Foam | 0 | 72 |
| Total, other adverse events | Roflumilast Foam 0.3% | 0 | 154 |
| Total, other adverse events | Vehicle Foam | 0 | 72 |
| Total, serious adverse events | Roflumilast Foam 0.3% | 0 | 154 |
| Total, serious adverse events | Vehicle Foam | 0 | 72 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37133856 | 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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Roflumilast Foam 0.3% vs Vehicle Foam: Achievement of Investigator Global Assessment (IGA) Success at Week 8 | Trial comparisons |
| 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/NCT04091646
GET https://conductscience.org/api/trials/v1/NCT04091646/results?page=2