This protocol addresses patients with severe acne vulgaris — encompassing severe recalcitrant nodular acne — where psychosocial burden and/or scarring defines the severity of disease.

Clinical Scenario

Severity in this population is characterised by nodular acne that is recalcitrant to conventional treatment, together with significant psychosocial impact and/or scarring. Patients with notable psychosocial burden or scarring qualify for this severity classification regardless of lesion count alone.

Treatment Approach

Oral isotretinoin is the recommended systemic agent for this presentation. The complete regimen — including dosing strategy, formulation choice, and mandatory safety requirements — is detailed in the full protocol.

Treatment Goals

The primary clinical target is a 90% reduction in lesion count and treatment success after 20 weeks of therapy.

References

DOI: 10.1016/j.jaad.2023.12.017

Oral isotretinoin, or 13-cis-retinoic acid, is the only FDA-approved treatment for severe recalcitrant nodular acne vulgaris since 1982.
Acne patients with psychosocial burden or scarring should be considered as having severe acne and to be candidates for isotretinoin.
In a RCT of 925 patients comparing standard isotretinoin with lidose-isotretinoin, 81.0% of patients treated with standard isotretinoin experienced a 90% reduction in lesion count and 88.9% of patients treated with standard isotretinoin achieved treatment success after 20 weeks of treatment.

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Treatment of Severe Acne Vulgaris Including Severe Recalcitrant Nodular Acne

References