Status:
COMPLETED
Long-Term Safety of ARQ-154 Foam in Subjects With Seborrheic Dermatitis
Lead Sponsor:
Arcutis Biotherapeutics, Inc.
Conditions:
Seborrheic Dermatitis
Eligibility:
All Genders
9+ years
Phase:
PHASE2
Brief Summary
This is an open-label, long-term safety study of roflumilast ARQ-154 foam 0.3% in subjects with seborrheic dermatitis involving up to 20% total Body Surface Area (BSA). Study was applied topically onc...
Eligibility Criteria
Inclusion
- Participants legally competent to sign and give informed consent or (for adolescents) assent.
- Males and females ages 9 years and older (inclusive) at the time of consent.
- Females of childbearing potential (FOCBP) must have a negative serum pregnancy test at all study visits.
- Post-menopausal women with spontaneous amenorrhea for at least 12 months or have undergone surgical sterilization.
- Cohort 1 only:
- Subjects with seborrheic dermatitis who met eligibility criteria for a prior ARQ-154 study, successfully completed a prior ARQ-154 study through final visit and are able to immediately enroll into this long-term safety study on the final visit of the previous ARQ-154 study.
- Cohort 2 subjects that have not participated in a prior ARQ-154 study:
- Clinical diagnosis of seborrheic dermatitis of at least 3 months duration as determined by the Investigator. Stable disease for the past 4 weeks.
- Seborrheic dermatitis of the scalp and/or face and/or trunk and/or intertriginous areas up to ≤20% BSA involvement.
- An Investigator Global Assessment (IGA) of disease severity of at least Moderate ('3') at Day 1.
- Overall Assessment of Erythema and Overall Assessment of Scaling scores of Moderate ('2') at Day 1.
- Cohort 2 subjects that have participated in a prior ARQ-154 study:
- Clinical diagnosis of seborrheic dermatitis of at least 3 months duration as determined by the Investigator.
- Seborrheic dermatitis of the scalp and/or face and/or trunk and/or intertriginous areas up to ≤20% BSA involvement.
Exclusion
- Planned excessive exposure of treated area(s) to either natural or artificial sunlight, tanning bed or other LED.
- Subjects with any condition on the treatment area which, in the opinion of the Investigator, could confound efficacy measurements.
- Subjects unable to apply investigational product to the scalp due to physical limitation.
- Known allergies to excipients in ARQ-154 foam.
- Subjects who cannot discontinue the use of strong P-450 cytochrome inhibitors e.g., indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketoconazole, nefazodone, saquinavir, suboxone and telithromycin during the study period.
- Known or suspected:
- severe renal insufficiency or moderate to severe hepatic disorders
- history of severe depression, suicidal ideation or C-SSRS indicative of suicidal ideation, whether lifetime or recent/recurrent.
- Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
- Subjects with any serious medical condition or laboratory abnormality that would prevent study participation or place the subject at significant risk, as determined by the Investigator.
- Subjects with a history of chronic alcohol or drugs abuse within 6 months of initiation of investigational product.
- Current or a history of cancer within 5 years with the exception of fully treated skin basal cell carcinoma, cutaneous squamous cell carcinoma or carcinoma in situ of the cervix.
- Subjects who are unable to communicate, read or understand the local language, or who display another condition, which in the Investigator's opinion, makes them unsuitable for clinical study participation.
- Subjects who are family members of the clinical study site, clinical study staff, or sponsor, or family members that live in the same household of enrolled subjects.
- Cohort 1 only:
- Subjects who experienced an ARQ-154 treatment-related AE or a serious AE (SAE) that precluded further treatment with ARQ-154 foam in a prior ARQ-154 study.
- Subjects that use any Excluded Medication and Treatments.
- Cohort 2 only:
- Subjects who cannot discontinue treatment with therapies for the treatment of seborrheic dermatitis prior to the Day 1 visit and during the study according to Excluded Medications and Treatments.
- Subjects with PHQ-8 \>10 or modified PHQ-A \>10 at Screening or Day 1.
- Cohort 2 subjects that have participated in a prior ARQ-154 study:
- Subjects who experienced an ARQ-154 treatment-related AE or a serious AE (SAE) that precluded further treatment with ARQ-154 foam in a prior ARQ-154 study.
Key Trial Info
Start Date :
June 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 19 2022
Estimated Enrollment :
408 Patients enrolled
Trial Details
Trial ID
NCT04445987
Start Date
June 12 2020
End Date
November 19 2022
Last Update
June 11 2024
Active Locations (39)
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1
Arcutis Biotherapeutics Clinical Site 59
Beverly Hills, California, United States, 90212
2
Arcutis Biotherapeutics Clinical Site 51
Encino, California, United States, 91436
3
Arcutis Biotherapeutics Clinical Site 75
Fountain Valley, California, United States, 92708
4
Arcutis Biotherapeutics Clinical Site 19
Fremont, California, United States, 94538