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Health Canada Accepts Arcutis Canada's Submission for Roflumilast Cream 0.15% in Atopic Dermatitis


Supportive data for roflumilast in adults and children 6 years of age and older stems from the INTEGUMENT studies.

Arcutis Biotherapeutics company logo on a website
Image Credit: © Dennis - stock.adobe.com

Arcutis Canada, Inc., announced today that Health Canada has accepted its Supplement to a New Drug Submission (SNDS) for roflumilast cream 0.15% to address mild to moderate atopic dermatitis (AD) in individuals aged 6 years and older.1

The SNDS is supported by positive data from various trials, including a phase 2 dose ranging study, an open label extension study, and 2 phase 1 pharmacokinetic studies.

However, the SNDS is also predominantly supported by results from the INterventional Trial EvaluatinG roflUMilast cream for the treatmENt of aTopic dermatitis (INTEGUMENT-1 and INTEGUMENT-2) trials.2 The phase 3, parallel-group, double-blind studies, involved participants ages 6 years and older with mild to moderate AD who applied either roflumilast cream 0.15% or a vehicle cream once daily for 4 weeks.

Both studies met the primary endpoint of Investigator Global Assessment (IGA) Success. In INTEGUMENT-1, 32.0% of patients treated with roflumilast cream achieved IGA Success compared to 15.2% with the vehicle. In INTEGUMENT-2, the figures were 28.9% and 12.0%, respectively.

Over 30% of patients in each study reported a significant reduction in itch (WI-NRS Success) at week 4. Rapid improvement in itch was noted within 24 hours of the first application. Furthermore, approximately 40% of patients achieved 'Clear' or 'Almost Clear' scores on the validated IGA-AD scale by week 4, and more than 40% of patients reached a 75% reduction in the Eczema Area and Severity Index (EASI-75) by week 4.

The incidence of treatment-emergent adverse events was low and predominantly mild to moderate. The most common adverse reactions were headache (2.9%), nausea (1.9%), and application site pain (1.5%).

Chih-ho Hong, MD, FRCPC, a principal investigator for the INTEGUMENT trials, emphasized roflumilast's potential to improve treatment adherence due to its formulation.

“Roflumilast cream is designed with the needs of AD patients in mind, free from ingredients that could compromise the skin barrier and common contact allergens," Hong said in a news release.1

Melinda Gooderham, MSc, MD, FRCPC, is medical director at the SKiN Centre for Dermatology and the principal Canadian investigator in the trials.

“The INTEGUMENT studies have shown that roflumilast cream 0.15%, when applied once daily, significantly improves AD symptoms and rapidly alleviates itch, a major concern for patients, within just 24 hours,” Gooderham said.1


  1. Arcutis Canada submission for roflumilast cream 0.15% accepted for review by Health Canada for the treatment of atopic dermatitis in adults and children 6 years of age and older. News release. PR Newswire. May 28, 2024. Accessed May 28, 2024. https://www.newswire.ca/news-releases/arcutis-canada-submission-for-roflumilast-cream-0-15-accepted-for-review-by-health-canada-for-the-treatment-of-atopic-dermatitis-in-adults-and-children-6-years-of-age-and-older-821418010.html
  2. Eichenfield L, Boguniewicz M, Simpson E, et al. Once-daily roflumilast cream 0.15% for atopic dermatitis: Pooled results: From INTEGUMENT-1/2 phase 3 trials. Ann Allergy Asthma Immunol. November 2023. https://doi.org/10.1016/j.anai.2023.08.273
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