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

• Status: Recruiting
• Trial end date: 2023-10-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zagazig University
• Treatments: Antimony Sodium Gluconate; Doxycycline; Voriconazole

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.