Trial of PDE4 Inhibition With Roflumilast (ARQ-154) Foam 0.3% for the Management of Seborrheic Dermatitis (STRATUM)

Arcutis Biotherapeutics

Status and phase: Completed; Phase 3

Conditions: Seborrheic Dermatitis

Treatments: Drug: Vehicle Foam; Drug: Roflumilast Foam

Study type: Interventional

Funder types: Industry

Identifiers

NCT04973228

ARQ-154-304

Details and patient eligibility

About

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.

Enrollment: 457 patients

Sex: All

Ages: 9+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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457 participants in 2 patient groups, including a placebo group

Roflumilast Foam 0.3%

Experimental group

Description:

Participants with seborrheic dermatitis apply roflumilast foam 0.3% once daily (QD) for 8 weeks.

Treatment:

Drug: Roflumilast Foam

Vehicle Foam

Placebo Comparator group

Description:

Participants with seborrheic dermatitis apply vehicle foam QD for 8 weeks.

Treatment:

Drug: Vehicle Foam