Recruiting
Phase 3

Roflumilast Cream

Sponsor:

Arcutis Biotherapeutics, Inc.

Code:

NCT07916480

Conditions

Atopic Dermatitis

Atopic Dermatitis (AD)

Atopic Dermatitis (Eczema)

Eligibility Criteria

Sex: All

Age: 6+

Healthy Volunteers: Not accepted

Interventions

Roflumilast Cream 0.3%

Vehicle Cream

Study Details

Brief summary:

This Phase 3 study is designed to evaluate the efficacy and safety of once-daily roflumilast cream 0.3% in children, adolescents, and adults with moderate to severe atopic dermatitis. Approximately 415 participants will be randomized in a 2:1 ratio to receive roflumilast cream 0.3% or matching vehicle cream during a 4-week double-blind, vehicle-controlled treatment period.

Following completion of the double-blind treatment period, all participants will enter a 48-week open-label extension and receive roflumilast cream 0.3%. The study will assess the efficacy of roflumilast cream 0.3% in improving signs and symptoms of atopic dermatitis and evaluate its long-term safety and tolerability through Week 52.

Conditions

Atopic Dermatitis

Atopic Dermatitis (AD)

Atopic Dermatitis (Eczema)

Study ID

NCT07916480

Start date

Oct 30, 2026

Status verified date

Nov, 2026

Completion date

Mar 28, 2029

Anticipated

Primary completion date

Apr 27, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Male or female participants aged 6 years and older.
2. Clinical diagnosis of moderate to severe atopic dermatitis.
3. vIGA-AD score of 3 (Moderate) or 4 (Severe) at baseline.
4. EASI score ≥5 at baseline.
5. Atopic dermatitis involvement of ≥3% and ≤30% body surface area.
6. Able and willing to comply with study procedures.
7. Participant or parent/legal guardian able to provide informed consent/assent.

Exclusion Criteria:

1. Uncontrolled medical conditions that could interfere with study participation.
2. Skin disorders that may confound study assessments.
3. Active infection requiring systemic treatment.
4. Known hypersensitivity to roflumilast or formulation components.
5. Use of prohibited medications within protocol-defined washout periods.
6. Pregnant or breastfeeding participants.
7. Participation in another interventional clinical trial within the protocol-defined timeframe.
8. Any condition that, in the investigator's opinion, would make participation unsafe or interfere with study results.

Study Design

Enrollment

415 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Vehicle Cream

Participants will apply matching vehicle cream once daily during the 4-week double-blind treatment period.

experimental: Roflumilast Cream 0.3%

Participants will apply roflumilast cream 0.3% once daily during the 4-week double-blind treatment period.

Interventions

Roflumilast Cream 0.3%

Roflumilast cream 0.3% administered topically once daily to affected areas during the 4-week double-blind treatment period. Participants may continue treatment with roflumilast cream 0.3% during the 48-week open-label extension.

Vehicle Cream

Matching vehicle cream administered topically once daily to affected areas during the 4-week double-blind treatment period. Participants will receive roflumilast cream 0.3% during the open-label extension phase.

Primary outcome measure

  • Achievement of vIGA-AD Success at Week 4 [ Time Frame: Week 4 ]

Central Contacts and Locations

Central contacts

Arcutis Medical Information

1-844-692-6729medinfo@arcutis.com

Locations

Arcutis Site 324

Recruiting

Birmingham, Alabama, United States, 35244

Arcutis Site 337

Recruiting

Bryant, Arkansas, United States, 72022

Arcutis Site 321

Recruiting

Miami Lakes, Florida, United States, 33014

Arcutis Site 320

Recruiting

Chicago, Illinois, United States, 60523

More Information

Sponsor

Arcutis Biotherapeutics, Inc.

Last update posted

Nov 6, 2026

Last verified

Nov, 2026

Keywords

  • Atopic Dermatitis
  • Eczema
  • Roflumilast
  • Roflumilast Cream
  • Phosphodiesterase 4 Inhibitor
  • PDE4 Inhibitor
  • Moderate Atopic Dermatitis
  • Severe Atopic Dermatitis
  • Pruritus
  • Inflammatory Skin Disease
  • Topical Therapy
  • Dermatology

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-07. This information was provided to ClinicalTrials.gov by Arcutis Biotherapeutics, Inc. on 2026-11-06. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.