Clinical Trials Logo

Clinical Trial 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).


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05708625
Study type Interventional
Source Zagazig University
Contact Hagar Nofal, Dr.
Phone 01006387707
Email hagarnofal@aucegypt.edu
Status Recruiting
Phase Phase 3
Start date January 1, 2022
Completion date March 1, 2024

See also
  Status Clinical Trial Phase
Terminated NCT01140191 - Safety, Efficacy, and PK of Topical Paromomycin/Gentamicin Cream for Treatment of Cutaneous Leishmaniasis Phase 2
Completed NCT03999970 - A Clinical Study to Develop an Uninfected Sand Fly Biting Protocol N/A
Completed NCT00111553 - Study to Evaluate the Leish-111F + MPL-SE Vaccine in the Treatment of Cutaneous Leishmaniasis Phase 1
Recruiting NCT03762070 - Evaluation of a Diagnostic Device, CL Detectâ„¢ Rapid Test, for the Diagnosis of Cutaneous Leishmaniasis in Peru
Completed NCT02894008 - A Study of a New Leishmania Vaccine Candidate ChAd63-KH Phase 2
Completed NCT03303898 - ASYMPTOMATIC CARRIER OF LEISHMANIA INFANTUM, MEDISERRANEAN VISCERAL LEISHMANIOSIS AGENT: STUDY OF IMMUNE RESPONSE - N/A
Recruiting NCT05094908 - Arnica Tincture Fot the Treatment of Cutaneous Leishmaniasis Phase 1
Completed NCT01083576 - Pharmacokinetics, Safety, and Efficacy Trial of WR 279,396 (Paromomycin + Gentamicin Topical Cream) and Paromomycin Topical Cream for the Treatment of Cutaneous Leishmaniasis in Panama Phase 2
Completed NCT03445897 - Miltefosine Plus IL Pentamidine for Bolivian CL Phase 2
Withdrawn NCT04072874 - Evaluation of the Safety and Clinical Activity of Curaleish in the Topical Treatment of Cutaneous Leishmaniasis. Phase 1/Phase 2
Completed NCT01032382 - Safety, Efficacy and Pharmacokinetics (PK) Study of WR 279,396 Versus Paromomycin for Treatment of Cutaneous Leishmaniasis (Peru-PK) Phase 2
Completed NCT00480883 - Treatment of Cutaneous Leishmaniasis With Meglumine Antimoniate Versus Meglumine Antimoniate and Allopurinol N/A
Completed NCT04841239 - Development of Topical Herbal Formulations for Treatment of Cutaneous Leishmaniasis N/A
Completed NCT00469495 - Antihelminthic Therapy Combined With Antimony in the Treatment of Cutaneous Leishmaniasis N/A
Completed NCT03294161 - Fourth-generation Immucillin Derivative DI4G Associated Therapy in Cutaneous Leishmaniasis Phase 2
Completed NCT04888130 - Investigation of an Outbreak Situation of Cutaneous Leishmaniasis Among Military Personnel in French Guiana (CEFELEISH)
Completed NCT03969134 - A Study to Assess the Safety, Efficacy and Immunogenicity of Leishmania Vaccine ChAd63-KH in PKDL Phase 2
Completed NCT03096457 - Topical Paromomycin for Cutaneous Leishmaniasis in Bolivia Phase 2/Phase 3
No longer available NCT00508963 - Compassionate Use of Sodium Stibogluconate (Pentostam) for Cutaneous and Mucocutaneous New World Leishmaniasis
No longer available NCT01641796 - Paromomycin for Individuals With Uncomplicated Cutaneous Leishmaniasis