What is the recommended management of cutaneous leishmaniasis in an immunocompetent adult with up to five lesions each ≤5 cm in diameter?

Management of Cutaneous Leishmaniasis in Immunocompetent Adults with Simple Lesions

Treatment Decision Algorithm

For immunocompetent adults with up to 5 lesions each ≤5 cm (clinically "simple" cutaneous leishmaniasis), the treatment approach depends critically on whether the infection was acquired in a region where Leishmania species carry increased risk for mucosal leishmaniasis (ML). 1

Step 1: Determine Geographic Risk for Mucosal Leishmaniasis

High ML-Risk Regions (New World):

• If acquired in Latin America where L. braziliensis, L. panamensis, or L. guyanensis are endemic, systemic treatment should be offered even for simple or healing lesions 1
• The risks and benefits of treatment versus watchful waiting should be discussed with the patient 1
• Systemic therapy options include: miltefosine (oral), liposomal amphotericin B, pentavalent antimonials, or amphotericin B deoxycholate 1, 2

Low ML-Risk Regions (Old World or select New World species):

• If caused by species NOT associated with ML risk (e.g., L. major, L. tropica, L. mexicana) and lesions are healing spontaneously, observation without treatment is acceptable if the patient agrees 1
• Local therapy is preferred for Old World cutaneous leishmaniasis with simple lesions 1

Step 2: Choose Treatment Modality Based on Risk Stratification

For High ML-Risk Cases (Systemic Treatment Recommended):

Oral Option - Miltefosine:

• Dosing: 50 mg twice daily (30-44 kg) or 50 mg three times daily (≥45 kg) for 28 consecutive days with food 3
• Critical contraindications: Pregnancy (obtain pregnancy test before prescribing), Sjögren-Larsson syndrome, hypersensitivity 3
• Contraception requirement: Females must use effective contraception during therapy and for 5 months after completion 3
• FDA-approved for cutaneous leishmaniasis caused by L. braziliensis, L. guyanensis, and L. panamensis 3

Parenteral Options:

• Liposomal amphotericin B: 3 mg/kg/day IV on days 1-5,14, and 21 (total 21 mg/kg) 2
• Pentavalent antimonials (sodium stibogluconate): 20 mg SbV/kg/day IV or IM for 20 days 1, 2
• Available in US under CDC-sponsored IND protocol 1

For Low ML-Risk Cases (Local Therapy Preferred):

Local Treatment Options Include: 1

• Intralesional pentavalent antimonials (with or without cryotherapy)
• Heat therapy or cryotherapy
• Topical paromomycin-containing ointments
• Photodynamic or laser treatment

Important caveat: Do NOT use intralesional injections on fingers, nose, ears, eyelids, near lips, or areas where vascular compromise is concerning 2

Before local therapy: Debride eschar overlying ulcers and manage any secondary bacterial infection to maximize treatment effect 1

Step 3: When to Use Systemic Therapy for Simple Lesions

Even in low ML-risk cases, consider systemic therapy if: 1

• Local therapy is impractical to administer
• Rapid healing of large, cosmetically or functionally concerning lesions is preferred
• Lesions are on cosmetically sensitive areas

Essential Management Components for ALL Cases

Regardless of treatment choice, every patient requires: 1

1. Wound care with individualized documentation of lesion evolution 1

2. Patient education about:

   • Signs/symptoms of treatment failure or relapse 1
   • Mucosal leishmaniasis warning signs: chronic nasal stuffiness, epistaxis, hoarseness, septal perforation 1

3. Active monitoring schedule:

   • Clinical examination including nasal and oropharyngeal examination periodically up to 1 year 1
   • Extended to at least 2 years if at increased risk for ML 1

4. Periodic reevaluation if observation without treatment is chosen—reconsider treatment if healing does not progress as anticipated 1

Monitoring Treatment Response

Clinical criteria alone should guide assessment of treatment response: 1

• Lesion flattening and >50% size decrease by 4-6 weeks 2
• Reepithelization of ulcerative lesions by approximately 3 months 2
• Do NOT repeat parasitologic testing if lesions appear to be healing 1
• Healing may continue after treatment completion, especially for large ulcerative lesions 1

Monitor lesions for 6-12 months after treatment and consider additional therapy when new lesions develop, existing lesions worsen, or incomplete healing occurs by 3 months post-treatment 2

Critical Pitfalls to Avoid

1. Never assume spontaneous healing will occur in New World leishmaniasis from ML-risk regions—the consequences of inadequate treatment include destructive and disfiguring mucosal disease 1

2. Do not prescribe miltefosine without a negative pregnancy test and confirmed contraception plan for 5 months post-treatment 3

3. Do not use intralesional therapy on anatomically sensitive areas where vascular compromise could occur 2

4. Do not rely on serologic testing for diagnosis of cutaneous leishmaniasis—currently available assays are neither sensitive nor specific 1

5. Never skip the nasal/oropharyngeal examination during follow-up, as mucosal involvement can be asymptomatic initially 1