Long-Term Safety of ARQ-154 Foam in Subjects With Seborrheic Dermatitis

  • STATUS
    Recruiting
  • End date
    Oct 6, 2022
  • participants needed
    410
  • sponsor
    Arcutis Biotherapeutics, Inc.
Updated on 6 May 2021
Investigator
Arcutis Study Inquiry
Primary Contact
Arcutis Biotherapeutics Clinical Site 58 (7.6 mi away) Contact
+35 other location
erythema

Summary

Open-label, long-term safety study of ARQ-154 foam 0.3% in subjects with seborrheic dermatitis involving up to 20% total Body Surface Area (BSA). Study medication will be applied by the qualifying subjects topically once daily for 52 weeks. Cohort 1 subjects are rollover subjects from a prior ARQ-154 trial. Cohort 2 include treatment naive subjects. Periodic clinic visits will include assessments for clinical safety, application site reactions, and disease improvement or progression.

Details
Condition Seborrheic dermatitis, Dermatitis, Hand Dermatitis, Seborrhea
Treatment ARQ-154
Clinical Study IdentifierNCT04445987
SponsorArcutis Biotherapeutics, Inc.
Last Modified on6 May 2021

Eligibility

Yes No Not Sure

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
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 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
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
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