Eczema (Atopic Dermatitis)
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Eczema (Atopic Dermatitis)
ARQ-151-315 Enrolling

Atopic Dermatitis Research Trial for Children (8 Weeks)


Treatment: Topical Age: 2 Years

Children 2-5 years of age diagnosed with atopic dermatitis (AD) prior to or at screening, may qualify to participate. Individuals must have mild to moderate AD with involvement of more than 3% body surface area (BSA). A history of AD for at least 6 weeks is required along with stable disease for the past 4 weeks with no significant flares, before screening.

Participants will receive investigational topical medication (active study drug) or placebo, via a cream. Study medication and study-related care will be provided at no cost. Reimbursement for study-related expenses will also be provided.

Study participation will last about 8 weeks and involve about 5 visits to the study centre.


The following information is from ClinicalTrials.gov

Last Update Posted: November 27, 2022

Official Title

A Phase 3, 4-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-151 Cream 0.05% Administered QD in Subjects With Atopic Dermatitis

ClinicalTrials.gov ID

NCT04845620

Sponsor

Arcutis Biotherapeutics, Inc.

Study Description

  • Brief 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).

  • Condition or Disease:

    Atopic Dermatitis Eczema

  • Intervention/Treatment:

    Drug: ARQ-151 Active
    Drug: ARQ-151 Vehicle
  • Phase:

    Phase 3

  • Ages Eligible for Study:

    2 Years and 5 Years (Child)

  • Sexes Eligible for Study:

    All

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.


Terms and Conditions – ClinicalTrials.gov
Purpose of ClinicalTrials.gov Database. The U.S. National Institutes of Health, Department of Health and Human Services, through its National Library of Medicine, has developed ClinicalTrials.gov to provide patients, family members, and members of the public current information about clinical research studies.


Participating Locations

COUNTRY
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Canada
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United States

Participating Experts

Dr. Nestor Cisneros

Pediatric Dermatologist

Dr. Rocco Serrao

Dermatologist

Dr. Alim Devani

Dermatologist

Dr. Vimal Prajapati

Dermatologist

Dr. Mariam Hanna

Pediatric Dermatologist

Dr. Douglas Mack

Pediatric Allergist

Dr. Kirsten Walker

Dermatologist

Dr. Vipul Jain

allergist

Dr. Charles Lynde

Dermatologist

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