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

NCT06998056 | Completed Phase 2 FDA Drug

• 1 other identifier: ARQ-151-218
• Study Type: interventional
• Target: 101
• Locations: 3 countries
• Sites: 22

Brief Summary

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)

Keywords

atopic dermatitis; eczema

Outcome Measures

Primary Outcomes (3)

• Subject incidence of adverse events

  Number of participants with adverse events during treatment will be assessed

  4 weeks

• Subject incidence of serious adverse events

  Number of participants with serious adverse events during treatment will be assessed

  4 weeks

• Incidence of application site reactions

  Number of subjects that experience an application site skin reaction by investigator assessment and application site reactions reported as adverse events will be assessed

  4 weeks

Study Arms (1)

ARQ-151 roflumilast cream 0.05% (open label)

EXPERIMENTAL

This single study arm is open label in which ARQ-151 cream 0.05% is applied daily for 4 weeks.

Drug: ARQ-151 cream 0.05%

Interventions

ARQ-151 cream 0.05% DRUG

ARQ-151 Cream 0.05% is applied once daily for 4 weeks in infants with atopic dermatitis (eczema).

ARQ-151 roflumilast cream 0.05% (open label)

Eligibility Criteria

• Age: 3 Months - 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Informed consent of a parent(s) or legal guardian(s), as required by local laws.
• Males and females, ages 3 months to \<2 years old at Day 1.
• Diagnosed with mild to moderate Atopic Dermatitis (AD) for at least 1 month duration prior to or at the screening visit.
• Has AD involvement of ≥3% BSA at Day1.
• In good health as judged by the Investigator
• 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.

You may not qualify if:

• 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.
• Subjects who have unstable AD or any consistent requirement for high potency topical steroids to manage AD signs or symptoms.
• Subjects previously treated with ARQ-151
• Subjects currently undergoing allergy testing or food challenges, or plan to do so during the study.
• 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.
• Subjects who are family members of the clinical study staff or sponsor.

Sponsors & Collaborators

• Arcutis Biotherapeutics, Inc.: lead

Study Sites (22)

Arcutis Clinical Study Site 208

Birmingham, Alabama, 35244, United States

Location

Arcutis Clinical Study Site 221

Bryant, Arkansas, 72022, United States

Location

Arcutis Clinical Study Site 214

Fountain Valley, California, 92708, United States

Location

Arcutis Clinical Study Site 209

Rancho Santa Margarita, California, 92688, United States

Location

Arcutis Clinical Study Site 207

Coral Gables, Florida, 33146, United States

Location

Arcutis Clinical Study Site 217

Delray Beach, Florida, 33484, United States

Location

Arcutis Clinical Study Site 213

Jacksonville, Florida, 32256, United States

Location

Arcutis Clinical Study Site 223

Boise, Idaho, 83706, United States

Location

Arcutis Clinical Study Site 219

West Lafayette, Indiana, 47906, United States

Location

Arcutis Clinical Study Site 212

Minneapolis, Minnesota, 55112, United States

Location

Arcutis Clinical Study Site 211

Portsmouth, New Hampshire, 03801, United States

Location

Arcutis Clinical Study Site 220

Mason, Ohio, 45040, United States

Location

Arcutis Clinical Study Site 206

Portland, Oregon, 97239, United States

Location

Arcutis Clinical Study Site 222

Summerville, South Carolina, 29486, United States

Location

Arcutis Clinical Study Site 210

Bellaire, Texas, 77401, United States

Location

Arcutis Clinical Study Site 224

Fort Worth, Texas, 76244, United States

Location

Arcutis Clinical Study Site 202

San Antonio, Texas, 78218, United States

Location

Arcutis Clinical Study Site 203

Winnipeg, Manitoba, R3J0S9, Canada

Location

Arcutis Clinical Study Site 204

Halifax, Nova Scotia, B3K 5R3, Canada

Location

Arcutis Clinical Study Site 216

Waterloo, Ontario, N2J1C4, Canada

Location

Arcutis Clinical Study Site 225

Saskatoon, Saskatchewan, S7K2C1, Canada

Location

Arcutis Clinical Study Site 201

Santo Domingo, 10306, Dominican Republic

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single arm open label study.

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: May 31, 2025
• Study Start: June 9, 2025
• Primary Completion: December 4, 2025
• Study Completion: December 4, 2025
• Last Updated: December 10, 2025

Record last verified: 2025-12

Locations

CA (4); DO (1); US (17)