Trial of PDE4 Inhibition With Roflumilast for the Management of Seborrheic Dermatitis (STRATUM)

• Status: Recruiting
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Arcutis Biotherapeutics, Inc.

Criteria

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.