RECRUITING

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

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).

Conditions

Atopic Dermatitis (Eczema)
Talk to us

Related Conditions:

Atopic Dermatitis (Eczema)

Study Overview

On this page

Study Details

Study overview

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).

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

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

Condition
Atopic Dermatitis (Eczema)
Intervention / Treatment

-

Contacts and Locations

Birmingham

Arcutis Clinical Study Site 208, Birmingham, Alabama, United States, 35244

Bryant

Arcutis Clinical Study Site 221, Bryant, Arkansas, United States, 72022

Rancho Santa Margarita

Arcutis Clinical Study Site 209, Rancho Santa Margarita, California, United States, 92688

Coral Gables

Arcutis Clinical Study Site 207, Coral Gables, Florida, United States, 33146

Jacksonville

Arcutis Clinical Study Site 213, Jacksonville, Florida, United States, 32256

West Lafayette

Arcutis Clinical Study Site 219, West Lafayette, Indiana, United States, 47906

Minneapolis

Arcutis Clinical Study Site 212, Minneapolis, Minnesota, United States, 55112

Portsmouth

Arcutis Clinical Study Site 211, Portsmouth, New Hampshire, United States, 03801

Mason

Arcutis Clinical Study Site 220, Mason, Ohio, United States, 45040

Fort Worth

Arcutis Clinical Study Site 224, Fort Worth, Texas, United States, 76244

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.

Ages Eligible for Study

3 Months to 2 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Arcutis Biotherapeutics, Inc.,

Study Record Dates

2026-06