NCT05708625

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 136 (estimated)
• Sponsor: Zagazig University · Other Government
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

Leishmaniasis is a vector-borne disease caused by obligate, intracellular protozoa of the genus Leishmania and transmitted by phlebotomine sandflies. It is found mostly in tropical and subtropical areas then it has spread into southern Europe. Increased international travel and immigration have led to an increased diagnosis of leishmaniasis cases in nonendemic areas (Kollipara et al., 2016). Foci of CL, caused by L. ma¬jor, occur in Afghanistan, Egypt, Iran, Iraq, Jordan, Libya, Morocco, Palestine, Pakistan, Saudi Arabia, Sudan, Syria, Tunisia, and Yemen. Many researchers have studied leishmaniasis in the endemic northern African countries, e.g., Morocco, Algeria, Tunisia, Egypt, and Libya. One of the established endemic leishmaniasis Libyan provinces is Al-jabal Al-gharbi province, where CL comprises a major parasitic health problem (Abdellatif et al., 2013).To evaluate the efficacy of intralesional cryotherapy, intralesional Voriconazole, and oral doxycycline in the treatment of cutaneous leishmaniasis compared to the conventional treatment (intralesional SSG).

Detailed description

* Cutaneous leishmaniasis is a prevalent parasitic infection in northern Africa. In Egypt, CL cases are detected mainly in eastern governorates including Sinai. Cutaneous leishmaniasis represent a socioeconomic burden on the affected communities. * Available treatment options are expensive and associated with systemic toxicity. There are alarming reports of emerging resistance against the currently in use therapeutics. Comparative controlled trials for the effective and the least harmful treatment modalities are lacking. * Up to our knowledge this is the first study investigating the effectiveness of intralesional Voriconazole and intralesional cryotherapy in the treatment of cutaneous leishmaniasis So in this study the following objectives are being aimed: 1. To evaluate the effectiveness and safety of intralesional Voriconazole comparing it to the intralesional SSG in patients with CL. 2. To evaluate the effectiveness and safety of intralesional cryotherapy comparing it to the intralesional SSG in patients with CL. 3. To evaluate the effectiveness and safety of Oral doxycycline comparing it to the intralesional SSG in patients with CL.

Conditions

• Leishmaniasis, Cutaneous

Interventions

Type	Name	Description
DRUG	Intralesional Sodium stibogluconate	Sessions will be held once weekly for a maximum of 6 weeks
PROCEDURE	Intralesional Cryotherapy	Intralesional Cryotherapy. Sessions will be held every two weeks
DRUG	Intralesional Voriconazole	Weekly intralesional Voriconazole
DRUG	Oral doxycycline	200 mg daily for 6 weeks or till complete cure

Timeline

• Start date: 2022-01-01
• Primary completion: 2023-12-01
• Completion: 2024-03-01
• First posted: 2023-02-01
• Last updated: 2023-08-29

Locations

1 site across 1 country: Libya