Complex Cutaneous Leishmaniasis When Initial Systemic Antileishmanial Therapy Did Not Achieve Adequate Response

This protocol applies to patients with complex cutaneous leishmaniasis whose initial course of systemic antileishmanial therapy failed to produce the expected clinical response — with new lesions developing, existing lesions worsening, or healing milestones not being met on schedule.

Complex CL — qualifying criteria (any one)

Caused by a Leishmania species with increased mucosal risk (Viannia spp.)
More than 4 skin lesions, or a single lesion ≥5 cm
Lesion on face, ears, eyelids, lips, fingers, toes, joints, or genitalia
Local subcutaneous nodules or large regional adenopathy
Clinical failure of local therapy
Unusual syndromes: leishmaniasis recidivans, diffuse cutaneous leishmaniasis, or disseminated cutaneous leishmaniasis

Prior treatment line — goals not reached

The patient received systemic antileishmanial therapy as the initial line. At the 4–6 week assessment, the expected response was not achieved: lesion size had not decreased by more than 50%, ulcerative lesions were not reepithelializing, or new lesions had continued to appear. Clinical healing by approximately 3 months was not on track.

Relatively little improvement or worsening while on therapy indicates an inadequate response and calls for a planned change in approach.

Next-line approach — partial overview

Management involves additional antileishmanial therapy, which is not necessarily given with a different agent. Options include repeating the same drug, switching to an alternative systemic agent, or combining approaches — for example, two antiparasitic agents together, or an antiparasitic alongside a physical modality. The specific selection criteria, sequencing, and full decision algorithm are contained in the complete protocol.

Treatment goals:

Lesion size reduction >50% by 4–6 weeks after treatment
Ulcerative lesions reepithelializing; no new lesions appearing
Full reepithelialization and clinical healing by approximately 3 months

Instant Access to Structured Evidence-Based Regimens

References

DOI: 10.1093/cid/ciw670

Systemic treatment is recommended for persons with complex CL as defined in Table 1.

Less common cutaneous syndromes, such as leishmaniasis recidivans (caused by L. tropica and occasionally other species), diffuse cutaneous leishmaniasis (caused by L. mexicana, L. amazonensis, and L. aethiopica), and disseminated cutaneous leishmaniasis (caused by L. [V.] braziliensis), usually require systemic therapy.

Additional therapy is recommended (but not necessarily always with a different agent or approach) when there is development of new skin lesions or worsening of existing lesions.

Relatively little improvement or worsening while on therapy suggests an inadequate response, and an alternate treatment approach should be planned.

By 4–6 weeks after treatment, the lesion size should have decreased by >50%, ulcerative lesions should be reepithelializing, and no new lesions should be appearing.

Ulcerative lesions are generally fully reepithelialized and clinically healed by approximately 3 months after treatment.

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