Zoryve (roflumilast cream) / Arcutis, Huadong Medicine, Sato Pharma - LARVOL DELTA

Efficacy and Tolerability of Roflumilast Cream 0.3% and Foam 0.3% in Patients With Plaque Psoriasis Involving the Face and/or Genitals: Outcomes From the Phase 3 DERMIS-1/2 and ARRECTOR Trials (EADV 2025) - No abstract available

Clinical • P3 data • Dermatology • Immunology • Psoriasis

Caregiver-Reported Outcomes From the Phase 3 INTEGUMENT-PED Trial of Children Aged 2–5 Years With Atopic Dermatitis and Treated With Roflumilast Cream 0.05% (EADV 2025) - No abstract available

Clinical • P3 data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Arcutis’ ZORYVE (roflumilast) Cream 0.15% Receives Strong Recommendation in American Academy of Dermatology Updated Guidelines for Adult Atopic Dermatitis (GlobeNewswire) - "Arcutis Biotherapeutics...announced that ZORYVE (roflumilast) cream 0.15% has received a strong recommendation in the focused guideline update for the management of adult AD from AAD. The recommendation highlights ZORYVE’s ability to deliver clinically meaningful improvements in pruritus and disease severity, its favorable tolerability profile, and low rates of treatment discontinuation, offering adults and pediatric patients 6 years of age and older with mild to moderate AD an effective, non-steroid option for daily disease management....The AAD’s strong recommendation helps guide clinicians and patients toward treatments that deliver clinically meaningful improvements in disease severity while being safe and well tolerated for long-term use. The focused update incorporates newly Food and Drug Administration (FDA)-approved topical and biologic therapies into existing guidelines..."

Clinical guideline • Atopic Dermatitis

A Case Report of Successful Treatment of Keratoderma Secondary to Severe Plantar Psoriasiform Dermatitis with Roflumilast Cream (CDA 2025) - "His medical history included dyslipidemia, alcohol use disorder, and non-alcoholic fatty liver disease, precluding the use of systemic treatments such as Methotrexate and Acitretin due to hepatotoxicity risk...Given the refractory nature of the condition and the patient’s contraindications to systemic therapy, the patient was enrolled for Dupilumab and while awaiting approval was prescribed Roflumilast 0.3% cream off-label for once-daily application...Its favorable safety profile, tolerability, and cost-effectiveness compared to biologics suggest its potential as a viable treatment option for PSD. Further studies are warranted to evaluate Roflumilast’s efficacy in inflammatory dermatoses and role in managing refractory cases."

Case report • Clinical • Addiction (Opioid and Alcohol) • Atopic Dermatitis • Dermatitis • Dermatology • Dyslipidemia • Hepatology • Immunology • Inflammation • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease • Psoriasis

The Treatment of Pembrolizumab-Induced Pruritus with Topical Roflumilast Cream 0.3% Once Daily. (PubMed, J Clin Aesthet Dermatol) - "In 2024, roflumilast was FDA-approved in a 0.15% cream vehicle for treatment of mild-to-moderate atopic dermatitis in patients six years of age and older. In this adult patient, pruritus was improved within 48 hours after initiation of roflumilast cream 0.3% applied once daily and continued to be effective with use over time."

Journal • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Oncology • Pruritus • Psoriasis • Seborrheic Dermatitis • PD-L2

Safety and tolerability of roflumilast cream from INTEGUMENT-1/2 trials of patients with atopic dermatitis and prior failure of topical treatments (CDA 2025) - P3 | "Patients aged ≥6 years with AD, Eczema Area and Severity Index ≥5, and Validated Investigator Global Assessment for AD (vIGA-AD) of Mild or Moderate were randomized 2:1 to once-daily roflumilast cream 0.15% or vehicle for 4 weeks. Safety and local tolerability were assessed through adverse events and investigator- and patient-rated local tolerability scales. Of 1137 patients in this pooled analysis (884 roflumilast, 453 vehicle), 60.8% reported prior TCS failure, 18.0% TCI failure, and 7.3% crisaborole failure."

Clinical • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pain

Topical Roflumilast as a Novel Treatment for Porokeratosis (CDA 2025) - "Current treatments include cryotherapy and topical therapy (retinoids, 5-fluorouracil, imiquimod and lovastatin with cholesterol); however, the efficacy of these treatments is limited and side-effects can be significant...Methods and Results Eight patients across three independent centers received 0.3% topical roflumilast cream once daily for the treatment of Porokeratosis...We report the findings of eight patients across three centers who achieved either a partial or complete resolution of PM and DSAP following topical roflumilast, highlighting its potential novel role in porokeratosis management. Studies investigating larger-scale use are warranted."

Dermatology • Immunology • Oncology • Psoriasis • Squamous Cell Carcinoma

Patient-reported outcomes and family impact with roflumilast cream in atopic dermatitis: pooled results from phase 3 INTEGUMENT-1 and INTEGUMENT-2 trials (CDA 2025) - P3 | "In two Phase 3 trials of patients with AD aged ≥ 6 years, once-daily roflumilast cream 0.15% improved signs of AD, patient-reported outcomes, and family impact."

Clinical • P3 data • Patient reported outcomes • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Focused update: Guidelines of care for the management of atopic dermatitis in adults. (PubMed, J Am Acad Dermatol) - "The workgroup developed strong recommendations for the use of tapinarof cream, roflumilast cream, lebrikizumab, and nemolizumab with concomitant topical therapy."

Journal • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Safety Study of Roflumilast Cream 0.05% in Infants Aged 3 Months to Less Than 2 Years With Atopic Dermatitis (clinicaltrials.gov) - P2 | N=100 | Recruiting | Sponsor: Arcutis Biotherapeutics, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

INTEGUMENT-INFANT Phase 2 Trial Will Assess Roflumilast in Pediatric Patients with AD (DermatologyTimes) - "The upcoming phase 2, open-label, single-arm INTEGUMENT-INFANT study will assess roflumilast cream 0.05%’s tolerability, safety, and efficacy in patients aged ≥3 months to <2 years...The primary endpoints will include safety and application-site tolerability, assessing changes in vital signs, adverse effects, and serious adverse events. The exploratory endpoints will evaluate effectiveness using the total BSA and Validated Investigator Global Assessment for AD (vIGA-AD) scores, along with the specific levels on the scalp."

Clinical protocol • Atopic Dermatitis

First infant enrolled in trial of roflumilast cream, 0.05% for atopic dermatitis in infants (Contemporary Pediatrics) - "Arcutis Biotherapeutics has enrolled the first patient of a planned phase 2 trial to evaluate investigational roflumilast cream 0.05% to treat atopic dermatitis (AD) among an infant population 3 months to less than 2 years of age, the company announced via a press release on June 10, 2025. The trial will be an open-label study called INTEGUMENT-INFANT, which will evaluate the safety and tolerability of the topical phosphodiesterase-4 (PDE4) inhibitor among approximately 35 infants with mild-to-moderate AD, applied once daily across 4 weeks."

Enrollment open • Atopic Dermatitis

Arcutis Presents Long-Term INTEGUMENT-OLE Data on Roflumilast at RAD 2025 (DermatologyTimes) - P3 | N=1,220 | INTEGUMENT-OLE (NCT04804605) | Sponsor: Arcutis Biotherapeutics, Inc. | "Arcutis Biotherapeutics will be presenting 5 posters at the 2025 Revolutionizing Atopic Dermatitis (RAD) Conference in Nashville, Tennessee, including new long-term results of roflumilast (Zoryve) cream 0.05%....At the week 4 mark, 30.2% of patients achieved a validated Investigator Global Assessment (vIGA-AD) score of clear (0) and switched to twice-weekly application. In these participants, the median duration of disease control was 238 days (34 weeks). Disease control was defined as maintaining a vIGA-AD score of clear or almost clear, along with adequate control of signs and symptoms. It was also proven that both roflumilast cream 0.15% and 0.05% significantly improved itch and reduced mean percent body surface area (BSA) in patients 2 and older."

P3 data • Atopic Dermatitis

Safety Study of Roflumilast Cream 0.05% in Infants Aged 3 Months to Less Than 2 Years With Atopic Dermatitis (clinicaltrials.gov) - P2 | N=100 | Not yet recruiting | Sponsor: Arcutis Biotherapeutics, Inc.

New P2 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Efficacy and tolerability of roflumilast cream 0.15% for atopic dermatitis: Pooled subgroup analysis of patients with face/eyelid involvement from phase 3 INTEGUMENT-1/2 trials (SID 2025) - P3 | "In the ROF group, no irritation/minimal erythema and no/mild sensation were reported by physicians and patients, respectively, for ≥97% and ≥81% at all timepoints across subgroups. Roflumilast cream 0.15% was well tolerated and improved outcomes in patients with AD involving the face or eyelids."

Clinical • P3 data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pain

Revise Phase III protocol: CDSCO Panel Tells Mankind Over Roflumilast Cream (Medical Dialogues) - "Responding to the proposal presented by Mankind Pharmaceutical to manufacture and market selective phosphodiesterase-4 inhibitor Roflumilast Cream 0.3% w/w, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the firm to revise the protocol of the proposed drug in respect to the amount of drugs applied, specific time of application, specific criteria for randomization, specific lab tests to assess the side effects, etc. This came after the firm presented their proposal for the manufacturing and marketing of Roflumilast Cream 0.3% w/w for the indication of topical treatment of plaque psoriasis, including treatment of psoriasis in the intertriginous areas, in patients 6 years of age and older with justification of bioequivalence (BE) waiver and phase III clinical trial protocol."

Clinical protocol • Psoriasis

Roflumilast Cream 0.3% for a Patient With Genital Psoriasis Refractory to Other Topical and Systemic Treatments: A Case Report. (PubMed, J Clin Aesthet Dermatol) - "After 28 weeks of initial treatment with guselkumab, body surface area (BSA) affected had fallen from 42 to 8 percent; however, new genital lesions were noted. At 16 weeks, genital and gluteal cleft disease remained well-controlled with no evidence of active disease. Overall, roflumilast cream 0.3% was well tolerated with no pruritus, folliculitis, irritation, or contact dermatitis observed."

Journal • Contact Dermatitis • Dermatitis • Dermatology • Immunology • Pruritus • Psoriasis

Efficacy and Safety of Roflumilast Cream in Atopic Dermatitis: A Systematic Review and Meta-Analysis of Randomised Controlled Trials. (PubMed, Australas J Dermatol) - "This systematic review and meta-analysis evaluated the efficacy and safety of roflumilast cream in treating atopic dermatitis (AD) by analysing data from three randomised controlled trials. The results demonstrated significant improvement in treatment success with roflumilast compared to vehicle creams, with a modest increase in mild adverse events, supporting its potential as an effective and well-tolerated treatment for AD."

Journal • Retrospective data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation

Arcutis to Present Two Posters at the 83rd American Academy of Dermatology Annual Meeting (GlobeNewswire) - "Arcutis Biotherapeutics, Inc...today announced that it will present two posters at the 2025 American Academy of Dermatology (AAD) annual meeting which will take place in Orlando, FL, from March 7 – 11, 2025. The Company will present data from two Phase 3 trials (INTEGUMENT-1 and -2) demonstrating pooled safety and local tolerability of roflumilast cream 0.15% in adults and children down to age six with AD who had prior inadequate response, intolerance, and/or contraindications to topical treatments including topical steroids. A second presentation will spotlight data from its Phase 3 ARRECTOR trial demonstrating significant improvements in patient-related outcomes with roflumilast foam 0.3% in individuals older than 12 years with psoriasis of the scalp and body."

P3 data • Atopic Dermatitis • Psoriasis

ZORYVE Cream 0.15% Approved by Health Canada for the Treatment of Mild to Moderate Atopic Dermatitis in Adults and Children as Young as Six Years of Age (Canada Newswire) - "Arcutis Canada...announced today that Health Canada has approved ZORYVE (roflumilast cream 0.15%), for the treatment of mild to moderate atopic dermatitis (AD) in adults and children ages 6 years and older....The approval of ZORYVE cream 0.15% for atopic dermatitis in Canada was supported by positive results from the vehicle-controlled pivotal Phase 3 INTEGUMENT-1 and INTEGUMENT-2 trials..."

Canada approval • Atopic Dermatitis

Pooled Safety and Local Tolerability of Roflumilast Cream 0.15% From the INTEGUMENT-1 and INTEGUMENT-2 Phase 3 Trials of Patients With Atopic Dermatitis: Subgroup Analysis of Patients With Prior Inadequate Response, Intolerance, and/or Contraindications to Topical Treatments (AAD 2025) - P3 | "Roflumilast cream 0.15% was well tolerated in patients with AD, including those with prior TCS, TCI, and/or crisaborole failure. Sponsored by Arcutis Biotherapeutics, Inc."

Clinical • P3 data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pain

Arcutis to Highlight Data from Phase 3 Trials for Scalp and Body Psoriasis and Atopic Dermatitis at the 83rd American Academy of Dermatology Meeting (GlobeNewswire) - P3 | N=432 | ARRECTOR (NCT05028582) | Sponsor: Arcutis Biotherapeutics, Inc. | "A second poster presentation shares results from the Phase 3 ARRECTOR trial that outlines improvements in patient-reported outcomes with investigational ZORYVE foam 0.3% compared with vehicle in adults and children aged 12 or older with psoriasis of the scalp and body. ZORYVE foam significantly improved quality of life across the 23-component Scalpdex assessment throughout the eight-week study period. Individuals reported an improvement in symptoms as well as a reduction in how psoriasis impacted their daily life (e.g., embarrassment, stress, affecting clothing choices, or hair styles)."

P3 data • Psoriasis

Arcutis to Highlight Data from Phase 3 Trials for Scalp and Body Psoriasis and Atopic Dermatitis at the 83rd American Academy of Dermatology Meeting (GlobeNewswire) - P3 | N=654 | INTEGUMENT-I (NCT04773587) | P3 | N=683 | INTEGUMENT-II (NCT04773600) | Sponsor: Arcutis Biotherapeutics, Inc. | "The first poster presentation details the positive efficacy, patient reported outcomes, and tolerability for the use of once-daily ZORYVE cream 0.15% in adults and children 6 years and older with mild to moderate AD from the INTEGUMENT 1-2 trials (n=1,337) who reported a prior inadequate response, intolerance or contraindication to topical corticosteroids (TCS; 60.8%), topical calcineurin inhibitors (TCI; 18.1%), or crisaborole (7.3%). At all timepoints assessed during the four-week trial, more than 91% of participants reported no or mild sensation at the application site and investigators reported no irritation or minimal erythema (redness) in ≥ 97% of participants in these subgroups. Improvement in AD was observed across multiple efficacy endpoints and safety was consistent with the overall study population."

P3 data • Atopic Dermatitis

Tapinarof cream (Vtama) for atopic dermatitis. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

U.S. FDA Accepts Supplemental New Drug Application for Arcutis’ ZORYVE (roflumilast) Cream 0.05% for the Treatment of Children Aged 2 to 5 with Mild to Moderate Atopic Dermatitis (GlobeNewswire) - "Arcutis Biotherapeutics...announced the FDA’s acceptance of a supplemental New Drug Application (sNDA) for ZORYVE (roflumilast) cream 0.05%, a once-daily, next generation phosphodiesterase-4 (PDE4) inhibitor, for the topical treatment of mild to moderate AD in children 2 to 5 years old. The FDA has set a PDUFA target action date of October 13, 2025 for this application....The sNDA is supported by positive results from the pivotal INTEGUMENT-PED Phase 3 trial (4 weeks), the INTEGUMENT-OLE long-term extension study (up to 52 weeks), as well as a Phase 1 pharmacokinetic study."

FDA filing • PDUFA • Atopic Dermatitis