Treating cutaneous leishmaniasis with different methods

Efficacy of Intralesional Voriconazole Versus Intralesional Cryotherapy Versus Intralesional Sodium Stibogluconate Versus Oral Doxycycline in the Treatment of Acute Cutaneous Leishmaniasis

This study is testing three different treatments for cutaneous leishmaniasis to see which one works best and is safest for people with new skin lesions.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 136 (estimated)
• Ages: 12 Years and up
• Sex: All
• Sponsor: Zagazig University (other gov)
• Locations: 1 site (Gharyan, Select Region)
• Trial ID: NCT05708625 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness and safety of three treatment options for cutaneous leishmaniasis: intralesional Voriconazole, intralesional cryotherapy, and oral doxycycline, compared to the standard treatment of intralesional sodium stibogluconate. The study focuses on patients with acute lesions of less than 12 weeks duration, aiming to identify the most effective and least harmful treatment modality. By comparing these interventions, the trial seeks to address the growing concern of resistance to current therapies and the socioeconomic burden of the disease in endemic regions.

Who should consider this trial

Good fit: Ideal candidates for this study are patients aged over 12 years with clinically diagnosed cutaneous leishmaniasis confirmed by parasitological tests and acute lesions of less than 12 weeks duration.

Not a fit: Patients under 12 years old, those with negative Giemsa stained smears, or with lesions longer than 12 weeks may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide more effective and safer treatment options for patients suffering from cutaneous leishmaniasis.

How similar studies have performed: This study is novel as it investigates the effectiveness of intralesional Voriconazole and cryotherapy in treating cutaneous leishmaniasis, with limited comparative controlled trials available in the literature.

Eligibility criteria

Inclusion Criteria:

* All participants must be willing to sign informed consent, for patients younger than 18 years old, parents or guardians will sign an informed consent.

  1. Patients clinically diagnosed with cutaneous leishmaniasis and confirmed using parasitological Giemsa-stained direct smears.
  2. Acute lesions of less than 12-week duration to exclude any possibility of natural self-healing of the lesions during follow-up.
  3. Both sexes.
  4. Age: \> 12 years old.

Exclusion Criteria:

* • Pregnancy and lactation.

  * Patients \< 12 years old.
  * Patients with negative Giemsa stained direct smears.
  * Patients with concomitant renal or liver impairment, congestive heart failure, uncontrolled diabetes mellitus, peripheral neuropathy, poor peripheral circulation, and prolonged corticosteroid therapy.
  * Patients with lesions of more than 12 weeks duration.
  * Patients with lesions \> 5cm2
  * History of anti-Leishmania therapy in the last 3 months.
  * For the intralesional groups the presence of \> 5 lesions.
  * Lesions in the perimeter (\< 2 cm) of mucosal areas e.g. eyes, nose, mouth, or genitals.
  * Patients with known hypersensitivity or allergy to the assigned drugs.

Where this trial is running

Gharyan, Select Region

• Dermatology department, Gharyan University Hospitals, Medical College, Gharyan University — Gharyan, Select Region, Libyan Arab Jamahiriya (RECRUITING)

Study contacts

• Principal investigator: Hagar Nofal, Dr — Zagazig University
• Study coordinator: Hagar Nofal, Dr.

Conditions: Leishmaniasis, Cutaneous