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Local Tolerability of Topical Roflumilast Across Dermatologic Conditions in Phase 3 Trials
According to a recent study published in SKIN The Journal of Cutaneous Medicine, topical roflumilast has demonstrated robust local tolerability profiles in patients with psoriasis, seborrheic dermatitis (SD), and atopic dermatitis (AD).
Roflumilast, a potent phosphodiesterase 4 inhibitor, is formulated as a water-based cream (0.15% for AD trials, 0.3% for psoriasis trials) or foam (0.3% for SD trials) that purposely excluding penetration enhancers and fragrances known to provoke skin irritation. This formulation choice aims to minimize adverse reactions, thereby enhancing patient comfort during application.
In recent phase 3 clinical trials, patients were randomized to receive either topical roflumilast or vehicle once daily for 4 to 8 weeks, depending on the specific trial protocol. Investigators assessed local tolerability using an 8-point scale before application, while patients rated tolerability on a 4-point scale shortly after application. Adverse events were also monitored throughout the trials.
Across all trials and time points, ≥96.5% of patients treated with roflumilast showed no evidence of irritation as assessed by investigators. Patient-reported tolerability was similarly positive, with only 1% experiencing severe sensations (score of 3) after the initial application, decreasing to less than 1% in subsequent assessments. Rates of adverse events, including those at the application site, were low, and discontinuation due to adverse events was minimal (<0.5% across all trials).
“Roflumilast cream and foam formulations demonstrated favorable local tolerability based on investigator- and patient-rated assessments in patients with psoriasis, SD, and AD, including application to sensitive areas such as the face and intertriginous areas,” concluded the study authors.
Reference:
Bunick C, Bhatia N, Del Rosso J, Draelos Z, et al. Investigator- and patient-rated local tolerability in phase 3 trials of topical roflumilast in patients with psoriasis, seborrheic dermatitis, and atopic dermatitis. SKIN The Journal of Cutaneous Medicine. 2024 8(1), s309. https://doi.org/10.25251/skin.8.supp.309
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Any views and opinions expressed are those of the author(s) and/or participants and do not necessarily reflect the views, policy, or position of The Dermatologist or HMP Global, their employees, and affiliates.
