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

ARQ-154-304

This phase 3, double-blind, vehicle-controlled study assessed the safety and efficacy of roflumilast (ARQ-154) foam 0.3% applied once daily (qd) for 8 weeks by participants with seborrheic dermatitis.

2021-07-08

2022-04-06

2022-04-06

Completed

Early phase I

457

Key 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. Key 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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 457, 'type': 'ACTUAL'}}

2024-03-12