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

  • STATUS
    Recruiting
  • End date
    May 11, 2022
  • participants needed
    450
  • sponsor
    Arcutis Biotherapeutics, Inc.
Updated on 11 September 2021
erythema

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.

Description

This is a parallel group, double blind, vehicle-controlled study in which ARQ-154 foam or vehicle is applied once daily for 8 weeks to subjects with seborrheic dermatitis.

Details
Condition Seborrheic dermatitis, Dermatitis
Treatment ARQ-154 - Active, ARQ-154 Vehicle
Clinical Study IdentifierNCT04973228
SponsorArcutis Biotherapeutics, Inc.
Last Modified on11 September 2021

Eligibility

Yes No Not Sure

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

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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