Intralesional Voriconazole, or Intralesional Cryotherapy, or Oral Doxycycline in the Treatment of Cutaneous Leishmaniasis

Launched by ZAGAZIG UNIVERSITY · Jan 31, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating different treatments for cutaneous leishmaniasis, which is a skin infection caused by a parasite transmitted by sandflies. The study is comparing three potential treatments: an injection of voriconazole directly into the skin, cryotherapy (freezing the lesions), and oral doxycycline (a type of antibiotic), against the standard treatment which involves another injection called SSG. Researchers are looking for patients who are at least 12 years old with recent skin lesions that are less than 12 weeks old, and who are willing to participate.

Participants in the trial can expect to receive one of the study treatments and will be monitored for how well it works in healing their skin lesions. It's important to note that there are some criteria that would exclude a person from participating, such as being pregnant, having certain health conditions, or having had other treatments for leishmaniasis recently. If you or someone you know is interested in this trial, please discuss it with a healthcare provider to see if it might be a good option.

Gender

ALL

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.