Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (Integument-PED)

  • STATUS
    Recruiting
  • days left to enroll
    13
  • participants needed
    650
  • sponsor
    Arcutis Biotherapeutics, Inc.
Updated on 4 October 2022

Summary

This study will assess the safety and efficacy of ARQ-151 cream vs vehicle applied once a day for 4 weeks by subjects with atopic dermatitis (eczema).

Description

This is a parallel group, double blind, vehicle-controlled study in which ARQ-151 cream or vehicle is applied once daily for 4 weeks to subjects with atopic dermatitis.

Details
Condition Atopic Dermatitis Eczema
Treatment ARQ-151 Active, ARQ-151 Vehicle
Clinical Study IdentifierNCT04845620
SponsorArcutis Biotherapeutics, Inc.
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Informed consent by parent(s) or legal guardian as required by local laws
Males and females, ages 2 to 5 years old at time of signing Informed Consent (Screening) and at Baseline (Day 1)
Diagnosed with atopic dermatitis for at least 6 weeks, as determined by the Investigator. Stable disease for the past 4 weeks with no significant flares in atopic dermatitis before screening
In good health as judged by the Investigator
Subjects considered reliable and capable of adhering to the Protocol and visit schedule, according to the judgment of the Investigator

Exclusion Criteria

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
Has unstable AD or any consistent requirement for high potency topical steroids
Subjects who are unwilling to refrain from prolonged sun exposure for 4 weeks prior to Baseline/Day 1 and during the study
Previous treatment with ARQ-151
Parent(s)/legal guardian(s) who are unable to communicate, read, or understand the local language(s). 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 of enrolled (in other studies of ARQ-151) subjects living in the same house
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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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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