What is the efficacy of Roflumilast (Daxas) for the treatment of palmoplantar pustulosis?

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Last updated: April 21, 2025View editorial policy

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From the Guidelines

Roflumilast is not recommended as a first-line treatment for palmoplantar pustulosis (PPP) due to the lack of direct evidence supporting its efficacy in this condition. The most recent and highest quality study available is from 2010, which compared acitretin with placebo in palmoplantar pustulosis, showing that acitretin was significantly more effective than placebo in reducing pustules 1. This study suggests that oral retinoids, such as acitretin, may be a more effective treatment option for PPP. Roflumilast, a phosphodiesterase-4 (PDE4) inhibitor, may be considered as an off-label option in certain cases, but its use should be based on individual patient needs and after other first-line treatments have failed.

  • Key points to consider when treating PPP include:
    • First-line treatments typically include high-potency topical corticosteroids, topical vitamin D analogs, phototherapy, or oral retinoids
    • Acitretin has been shown to be effective in reducing pustules in PPP, with a fivefold reduction in pustules after 4 weeks and a tenfold reduction after 12 weeks 1
    • Roflumilast may be considered as an off-label option, but its efficacy and safety in PPP are not well established
    • Patients should be closely monitored for side effects and treatment response, and alternative treatments should be considered if there is no improvement after an adequate trial period.

From the Research

Roflumast for Palmoplantar Pustulosis

  • There is no mention of Roflumast in the provided studies as a treatment for palmoplantar pustulosis 2, 3, 4, 5, 6.
  • The studies discuss various treatments for palmoplantar pustulosis, including topical corticosteroids, oral retinoids, phototherapy, and biologics, but Roflumast is not mentioned as an option 2, 3, 4, 5, 6.
  • The current evidence suggests that treatments such as topical vitamin D derivatives, PUVA therapy, and biologics like secukinumab and guselkumab may be effective in reducing severity and achieving clearance, but the quality of evidence is limited by risk of bias and imprecision 5.
  • Further research is needed to determine the effectiveness of various treatments for palmoplantar pustulosis, including the potential use of Roflumast, which is not currently supported by the available evidence 2, 3, 4, 5, 6.

References

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Research

Interventions for chronic palmoplantar pustulosis.

The Cochrane database of systematic reviews, 2020

Research

Palmoplantar Pustulosis: Therapy Update.

Journal of drugs in dermatology : JDD, 2024

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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