Study Description
Brief Summary
The study will assess the safety and efficacy of ARQ-154 foam vs vehicle applied once for 8 weeks by subjects with seborrheic dermatitis.
Condition or Disease
Seborrheic Dermatitis
Study Design
| Study Type: | Interventional (Clinical Trial) |
| Actual Enrollment: | 457 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 3, 8-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-154 Foam 0.3% Administered QD in Subjects With Seborrheic Dermatitis |
| Actual Study Start Date: | July 8, 2021 |
| Actual Primary Completion Date: | April 6, 2022 |
| Actual Study Completion Date: | April 6, 2022 |
Outcome Measures
Primary Outcome Measures
- Investigator Global Assessment Scale (IGA) Score Change [ Time Frame: Week 8 ]
IGA Success, defined as an IGA score of ‘clear’ or ‘almost clear’ plus a 2-point improvement 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).
Secondary Outcome Measures
- In subjects with a Baseline WI-NRS pruritus score of ≥ 4, WI-NRS Success, defined as achievement of a ≥ 4-point improvement from Baseline. [ Time Frame: 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 to 10’ (“no itch” to “worst imaginable itch”).
- In subjects with a Baseline WI-NRS pruritus score of ≥ 4, WI-NRS Success, defined as achievement of a ≥ 4-point improvement from Baseline. [ Time Frame: Week 4 ]
WI-NRS is a subject-reported severity of itch at its highest intensity during the previous 24-hour period. The scale is from ‘0 to 10’ (“no itch” to “worst imaginable itch”).
- In subjects with a Baseline WI-NRS pruritus score of ≥ 4, WI-NRS Success, defined as achievement of a ≥ 4-point improvement from Baseline. [ Time Frame: Week 2 ]
WI-NRS is a subject-reported severity of itch at its highest intensity during the previous 24-hour period. The scale is from ‘0 to 10’ (“no itch” to “worst imaginable itch”).
- IGA Success [ Time Frame: Week 4 ]
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).
- Overall Assessment of Scaling Score [ Time Frame: Week 8 ]
Achievement of an Overall Assessment of Scaling score of 0. This assessment scale has four severity grades reported from 0-3 and defined as None (0), Mild (1), Moderate (2), Severe (3).
- Overall Assessment of Erythema Score [ Time Frame: Week 8 ]
Achievement of an Overall Assessment of Erythema score of 0. This assessment scale has four severity grades reported from 0-3 and defined as None (0), Mild (1), Moderate (2), Severe (3).
- Investigator Global Assessment Scale (IGA) Score Change [ Time Frame: Week 8 ]
Achievement of an IGA score of ‘clear’. 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).
- IGA Success [ Time Frame: Week 2 ]
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).
Eligibility Criteria
| Ages Eligible for Study: | 9 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
- Participants legally competent to sign and give informed consent and, if appropriate, assent as required by local laws.
- Males and females ages 9 years and older at the time of consent.
- Clinical diagnosis of seborrheic dermatitis of at least 3 months duration at Screening as determined by the Investigator. Stable disease for the past 4 weeks.
- Seborrheic dermatitis up to 20% BSA involvement. Involvement may be of the scalp and/or face and/or trunk and/or intertriginous areas.
- An Investigator Global Assessment (IGA) disease severity of at least Moderate (‘3’) at Baseline.
- Overall Assessment of Erythema and Overall Assessment of Scaling scores of at least Moderate (‘2’) at Baseline.
- Females of childbearing potential (FOCBP) must have a negative serum pregnancy test at Screening (Visit 1) and a negative urine pregnancy test at Baseline (Visit 2).
- Females of non-childbearing potential must either be post-menopausal with spontaneous amenorrhea for at least 12 months or have undergone surgical sterilization.
- Subjects in good health as judged by the Investigator.
- Subjects are considered reliable and capable of adhering to the Protocol and visit schedule according to the Investigator judgment.
Exclusion Criteria
- Subjects who cannot discontinue treatment with therapies for the treatment of seborrheic dermatitis prior to the Baseline visit and during the study.
- Planned excessive exposure of treated area(s) to either natural or artificial sunlight, tanning bed or other LED.
- Previous treatment with ARQ-154 or ARQ-151.
- Subjects with any serious medical condition or clinically significant abnormality that would prevent study participation or place the subject at significant risk, as judged by the Investigator.
- Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
- Subjects with a history of chronic alcohol or drug abuse within 6 months prior to Screening.
- Subjects, parent(s)/legal guardian(s) who are unable to communicate, read, or understand the local language(s).
- Subjects who are family members of the clinical study site, clinical study staff, or sponsor, or family members living in the same house of enrolled subjects.