RECRUITING

Safety Study of Roflumilast Cream 0.05% in Infants Aged 3 Months to Less Than 2 Years With Atopic Dermatitis

Conditions

Atopic Dermatitis (Eczema)atopic dermatitis eczema

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study will assess the safety and tolerability of ARQ-151 cream 0.05% applied once a day for 4 weeks in infants with atopic dermatitis (eczema).

Official Title

A Phase 2, Open Label, 4-Week, Safety Study of Roflumilast Cream 0.05% Administered Once Daily in Infants Aged 3 Months to Less Than 2 Years With Atopic Dermatitis

Quick Facts

Study Start:2025-06-09

Study Completion:2026-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06998056

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:3 Months to 2 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion Criteria
1. Informed consent of a parent(s) or legal guardian(s), as required by local laws. 2. Males and females, ages 3 months to \<2 years old at Day 1. 3. Diagnosed with mild to moderate Atopic Dermatitis (AD) for at least 1 month duration prior to or at the screening visit. 4. Has AD involvement of ≥3% BSA at Day1. 5. In good health as judged by the Investigator 6. Subjects and parent(s)/legal guardian(s) are considered reliable and capable of adhering to the Protocol and visit schedule, according to the judgment of the Investigator.	1. Subjects with any serious medical condition, clinically significant vital signs, or physical examination abnormality that would prevent study participation or place the subject at significant risk, as judged by the Investigator. 2. Subjects who have unstable AD or any consistent requirement for high potency topical steroids to manage AD signs or symptoms. 3. Subjects previously treated with ARQ-151 4. Subjects currently undergoing allergy testing or food challenges, or plan to do so during the study. 5. Parent(s)/legal guardian(s) who are unable to communicate, read, or understand the local language. Subjects who display another condition, which in the Investigator's opinion, makes them unsuitable for clinical study participation. 6. Subjects who are family members of the clinical study staff or sponsor.

Inclusion Criteria

Exclusion Criteria

1. Informed consent of a parent(s) or legal guardian(s), as required by local laws.
2. Males and females, ages 3 months to \<2 years old at Day 1.
3. Diagnosed with mild to moderate Atopic Dermatitis (AD) for at least 1 month duration prior to or at the screening visit.
4. Has AD involvement of ≥3% BSA at Day1.
5. In good health as judged by the Investigator
6. Subjects and parent(s)/legal guardian(s) are considered reliable and capable of adhering to the Protocol and visit schedule, according to the judgment of the Investigator.

1. Subjects with any serious medical condition, clinically significant vital signs, or physical examination abnormality that would prevent study participation or place the subject at significant risk, as judged by the Investigator.
2. Subjects who have unstable AD or any consistent requirement for high potency topical steroids to manage AD signs or symptoms.
3. Subjects previously treated with ARQ-151
4. Subjects currently undergoing allergy testing or food challenges, or plan to do so during the study.
5. Parent(s)/legal guardian(s) who are unable to communicate, read, or understand the local language. Subjects who display another condition, which in the Investigator's opinion, makes them unsuitable for clinical study participation.
6. Subjects who are family members of the clinical study staff or sponsor.

Contacts and Locations

Study Contact

Arcutis Medical Information Arcutis Biotherapeutics, Inc.

CONTACT

1-844-692-6729

medinfo@arcutis.com

Study Director, Arcutis Biotherapeutics, Inc.

CONTACT

Study Locations (Sites)

Arcutis Clinical Study Site 208

Birmingham, Alabama, 35244

United States

Arcutis Clinical Study Site 221

Bryant, Arkansas, 72022

United States

Arcutis Clinical Study Site 209

Rancho Santa Margarita, California, 92688

United States

Arcutis Clinical Study Site 207

Coral Gables, Florida, 33146

United States

Arcutis Clinical Study Site 213

Jacksonville, Florida, 32256

United States

Arcutis Clinical Study Site 219

West Lafayette, Indiana, 47906

United States

Arcutis Clinical Study Site 212

Minneapolis, Minnesota, 55112

United States

Arcutis Clinical Study Site 211

Portsmouth, New Hampshire, 03801

United States

Arcutis Clinical Study Site 220

Mason, Ohio, 45040

United States

Arcutis Clinical Study Site 224

Fort Worth, Texas, 76244

United States

Collaborators and Investigators

Sponsor: Arcutis Biotherapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-09

Study Completion Date2026-06

Study Record Updates

Study Start Date2025-06-09

Study Completion Date2026-06

Terms related to this study

Keywords Provided by Researchers

atopic dermatitis
eczema

Additional Relevant MeSH Terms

Atopic Dermatitis (Eczema)