Long-Term Safety of ARQ-154 Foam in Subjects With Seborrheic Dermatitis (NCT04445987) | Clinical Trial Compass
CompletedPhase 2
Long-Term Safety of ARQ-154 Foam in Subjects With Seborrheic Dermatitis
United States408 participantsStarted 2020-06-12
Plain-language 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 once daily for 52 weeks. Cohort 1 subjects are rollover subjects from study ARQ-154-203 (NCT04091646) and were rolled into treatment in the current study without interruption. Cohort 2 includes participants from ARQ-154-203 who began treatment in the current study after a gap from completing treatment in the prior study.
Who can participate
Age range9 Years
SexALL
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Inclusion criteria
✓. 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.
✓. 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.
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
Number of Participants With ≥1 Adverse Event (AE)
Timeframe: Up to 52 weeks
2
Number of Participants With ≥1 Serious Adverse Event (SAE)
. 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:
✕. 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.