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ClinicalTrials.gov public records Last synced Sep 17, 2026, 6:23 PM EDT

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Showing 1–19 of 19 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: Topical roflumilast Clear all
Not yet recruiting Phase 2 Interventional

Safety and Efficacy of Roflumilast Foam 0.3% in Adolescent and Adult Subjects With Hidradenitis Suppurativa

NCT07689188
View directory record Official record
Conditions
Hidradenitis Suppurativa (HS)
Interventions
Roflumilast 0.3% topical foam
Drug
Lead sponsor
Harrison Dermatology
Other
Eligibility
12 Years and older
Enrollment
10 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2028
U.S. locations
1
States / cities
Missouri City, Texas
Source: ClinicalTrials.gov public record
Updated Jul 8, 2026 · Synced Sep 17, 2026, 6:23 PM EDT
Completed Phase 3 Interventional Results available

Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (Integument-PED)

NCT04845620
View directory record Official record
Conditions
Atopic Dermatitis Eczema
Interventions
Roflumilast Cream 0.05%, Vehicle Cream
Drug
Lead sponsor
Arcutis Biotherapeutics, Inc.
Industry
Eligibility
2 Years to 5 Years
Enrollment
652 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2023
U.S. locations
71
States / cities
Birmingham, Alabama • Montgomery, Alabama • Gilbert, Arizona + 60 more
Source: ClinicalTrials.gov public record
Updated Dec 22, 2025 · Synced Sep 17, 2026, 6:23 PM EDT
Completed Phase 2 Interventional Results available

Safety and Efficacy of ARQ-151 Cream in Adolescents and Adults With Atopic Dermatitis

NCT03916081
View directory record Official record
Conditions
Atopic Dermatitis
Interventions
Roflumilast Cream 0.05%, Roflumilast Cream 0.15%, Vehicle Cream
Drug
Lead sponsor
Arcutis Biotherapeutics, Inc.
Industry
Eligibility
12 Years and older
Enrollment
136 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019
U.S. locations
17
States / cities
Scottsdale, Arizona • San Diego, California • Hialeah, Florida + 14 more
Source: ClinicalTrials.gov public record
Updated Feb 12, 2023 · Synced Sep 17, 2026, 6:23 PM EDT
Not yet recruiting Phase 4 Interventional

An Open Label Trial to Evaluate Efficacy and Safety of Roflumilast 0.3% Cream for Chronic Plaque and Nail Psoriasis

NCT07725822
View directory record Official record
Conditions
Chronic Plaque Psoriasis, Nail Psoriasis
Interventions
Roflumilast 0.3% topical cream
Drug
Lead sponsor
Modern Research Associates, PLLC
Other
Eligibility
Not listed
Enrollment
15 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2027
U.S. locations
1
States / cities
Dallas, Texas
Source: ClinicalTrials.gov public record
Updated Jul 27, 2026 · Synced Sep 17, 2026, 6:23 PM EDT
Completed Phase 3 Interventional Results available

Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (INTEGUMENT-II)

NCT04773600
View directory record Official record
Conditions
Atopic Dermatitis Eczema
Interventions
Roflumilast Cream, Vehicle cream
Drug
Lead sponsor
Arcutis Biotherapeutics, Inc.
Industry
Eligibility
6 Years and older
Enrollment
683 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2022
U.S. locations
44
States / cities
Birmingham, Alabama • Fort Smith, Arkansas • Inglewood, California + 38 more
Source: ClinicalTrials.gov public record
Updated Oct 3, 2024 · Synced Sep 17, 2026, 6:23 PM EDT
Completed Phase 2 Interventional Results available

Safety and Efficacy of ARQ-154 Foam in Subjects With Seborrheic Dermatitis

NCT04091646
View directory record Official record
Conditions
Seborrheic Dermatitis
Interventions
Roflumilast Foam 0.3%, Vehicle foam
Drug
Lead sponsor
Arcutis Biotherapeutics, Inc.
Industry
Eligibility
18 Years and older
Enrollment
226 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2020
U.S. locations
22
States / cities
Fremont, California • Santa Monica, California • Coral Gables, Florida + 19 more
Source: ClinicalTrials.gov public record
Updated Jul 2, 2023 · Synced Sep 17, 2026, 6:23 PM EDT
Completed Phase 2 Interventional Accepts healthy volunteers

Evaluation of the Safety and Efficacy of Topical Roflumilast Cream in the Treatment of Facial Papulopustular Rosacea

NCT05278624
View directory record Official record
Conditions
Rosacea
Interventions
Roflumilast Cream
Drug
Lead sponsor
Dermatology Consulting Services, PLLC
Network
Eligibility
18 Years to 70 Years
Enrollment
40 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2022 – 2023
U.S. locations
1
States / cities
High Point, North Carolina
Source: ClinicalTrials.gov public record
Updated May 30, 2023 · Synced Sep 17, 2026, 6:23 PM EDT
Recruiting Phase 2 Interventional

The Safety and Efficacy of Roflumilast Foam in HS

NCT07263230
View directory record Official record
Conditions
Hidradenitis Suppurativa (HS)
Interventions
Roflumilast 0.3% topical foam
Drug
Lead sponsor
Beth Israel Deaconess Medical Center
Other
Eligibility
18 Years and older
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2029
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Jul 8, 2026 · Synced Sep 17, 2026, 6:23 PM EDT
Completed Phase 2 Interventional Results available

Maximal Usage Pharmacokinetics and Safety of ARQ-151 in Children With Plaque Psoriasis (ARQ-151-216)

NCT04746911
View directory record Official record
Conditions
Psoriasis, Plaque Psoriasis
Interventions
ARQ-151 cream 0.3%
Drug
Lead sponsor
Arcutis Biotherapeutics, Inc.
Industry
Eligibility
2 Years to 5 Years
Enrollment
10 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2022
U.S. locations
16
States / cities
Mountain Brook, Alabama • Scottsdale, Arizona • Fountain Valley, California + 10 more
Source: ClinicalTrials.gov public record
Updated Aug 6, 2026 · Synced Sep 17, 2026, 6:23 PM EDT
Completed Phase 2 Interventional Results available

Maximal Usage Pharmacokinetics and Safety of ARQ-151 in Children With Plaque Psoriasis (ARQ-151-215)

NCT04655313
View directory record Official record
Conditions
Psoriasis, Plaque Psoriasis
Interventions
ARQ-151 cream 0.3%
Drug
Lead sponsor
Arcutis Biotherapeutics, Inc.
Industry
Eligibility
6 Years to 11 Years
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2022
U.S. locations
15
States / cities
Mountain Brook, Alabama • Scottsdale, Arizona • Fountain Valley, California + 11 more
Source: ClinicalTrials.gov public record
Updated Dec 14, 2023 · Synced Sep 17, 2026, 6:23 PM EDT
Recruiting Phase 2 Interventional

An Open-label Single Center, Proof of Concept Study Evaluating the Efficacy of Roflumilast Foam 0.3% in Pediatric Patients With Non-Segmental Vitiligo (NSV)

NCT07105254
View directory record Official record
Conditions
Non-segmental Vitiligo
Interventions
Roflumilast topical 0.3% foam
Drug
Lead sponsor
Derm Texas, PLLC
Network
Eligibility
2 Years to 18 Years
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2026
U.S. locations
1
States / cities
Dallas, Texas
Source: ClinicalTrials.gov public record
Updated Aug 7, 2025 · Synced Sep 17, 2026, 6:23 PM EDT
Completed Phase 3 Interventional Results available

Topical Roflumilast to Treat Scalp and Body Psoriasis (ARRECTOR)

NCT05028582
View directory record Official record
Conditions
Scalp Psoriasis
Interventions
Roflumilast Foam 0.3%, Vehicle Foam
Drug
Lead sponsor
Arcutis Biotherapeutics, Inc.
Industry
Eligibility
12 Years and older
Enrollment
432 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2022
U.S. locations
36
States / cities
Scottsdale, Arizona • Beverly Hills, California • Encinitas, California + 31 more
Source: ClinicalTrials.gov public record
Updated Jul 16, 2025 · Synced Sep 17, 2026, 6:23 PM EDT
Recruiting Phase 4 Interventional

Obtaining Descriptive Classifications of Pruritus and Assessing Change in Pruritus Over Time in Atopic Dermatitis Patients Using Topical Roflumilast Cream.

NCT07560618
View directory record Official record
Conditions
ITCH, Atopic Dermatitis
Interventions
Roflumilast Cream 0.15%
Drug
Lead sponsor
Integrative Skin Science and Research
Industry
Eligibility
12 Years and older
Enrollment
40 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2027
U.S. locations
1
States / cities
Sacramento, California
Source: ClinicalTrials.gov public record
Updated Aug 12, 2026 · Synced Sep 17, 2026, 6:23 PM EDT
Completed Phase 3 Interventional Results available

Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis

NCT04211363
View directory record Official record
Conditions
Chronic Plaque Psoriasis
Interventions
Roflumilast 0.3% cream, Vehicle Cream
Drug
Lead sponsor
Arcutis Biotherapeutics, Inc.
Industry
Eligibility
2 Years and older
Enrollment
439 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2020
U.S. locations
31
States / cities
Encinitas, California • Fremont, California • Irvine, California + 26 more
Source: ClinicalTrials.gov public record
Updated Dec 6, 2022 · Synced Sep 17, 2026, 6:23 PM EDT
Completed Phase 2 Interventional Results available

Long-Term Safety of ARQ-151 Cream in Adult Subjects With Chronic Plaque Psoriasis

NCT03764475
View directory record Official record
Conditions
Plaque Psoriasis
Interventions
Roflumilast
Drug
Lead sponsor
Arcutis Biotherapeutics, Inc.
Industry
Eligibility
18 Years and older
Enrollment
332 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2020
U.S. locations
20
States / cities
Beverly Hills, California • Northridge, California • San Diego, California + 16 more
Source: ClinicalTrials.gov public record
Updated Sep 1, 2022 · Synced Sep 17, 2026, 6:23 PM EDT
Completed Phase 3 Interventional Results available

Open-Label Extension Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis

NCT04286607
View directory record Official record
Conditions
Chronic Plaque Psoriasis
Interventions
Topical roflumilast
Drug
Lead sponsor
Arcutis Biotherapeutics, Inc.
Industry
Eligibility
2 Years to 11 Years
Enrollment
337 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2024
U.S. locations
68
States / cities
Scottsdale, Arizona • Beverly Hills, California • Encinitas, California + 58 more
Source: ClinicalTrials.gov public record
Updated Sep 8, 2026 · Synced Sep 17, 2026, 6:23 PM EDT
Not listed Phase 4 Interventional Accepts healthy volunteers

Visualization of Topical Zoryve vs. Vehicle Using Line Field Optical Coherence Tomography in Healthy Skin

NCT06440473
View directory record Official record
Conditions
Healthy Skin
Interventions
Roflumilast, Vehicle (Roflumilast 0.3% vehicle cream)
Drug · Other
Lead sponsor
Rao Dermatology
Other
Eligibility
18 Years and older
Enrollment
3 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2024
U.S. locations
1
States / cities
Atlantic Highlands, New Jersey
Source: ClinicalTrials.gov public record
Updated Jun 2, 2024 · Synced Sep 17, 2026, 6:23 PM EDT
Recruiting Phase 2 Interventional

A Study for Evaluating Safety & Efficacy of Topical Roflumilast 0.3% Foam in Hidradenitis Suppurativa

NCT07077902
View directory record Official record
Conditions
Hidradenitis Suppurativa
Interventions
Topical roflumilast 0.3% foam
Drug
Lead sponsor
Tulane University
Other
Eligibility
18 Years to 90 Years
Enrollment
10 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2026
U.S. locations
4
States / cities
Covington, Louisiana • New Orleans, Louisiana
Source: ClinicalTrials.gov public record
Updated Dec 22, 2025 · Synced Sep 17, 2026, 6:23 PM EDT
Completed Phase 3 Interventional Results available

Trial of PDE4 Inhibition With Roflumilast (ARQ-154) Foam 0.3% for the Management of Seborrheic Dermatitis (STRATUM)

NCT04973228
View directory record Official record
Conditions
Seborrheic Dermatitis
Interventions
Roflumilast Foam, Vehicle Foam
Drug
Lead sponsor
Arcutis Biotherapeutics, Inc.
Industry
Eligibility
9 Years and older
Enrollment
457 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2022
U.S. locations
43
States / cities
Scottsdale, Arizona • Encinitas, California • San Diego, California + 37 more
Source: ClinicalTrials.gov public record
Updated Mar 11, 2024 · Synced Sep 17, 2026, 6:23 PM EDT