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

Zagazig University

Status and phase

Enrolling

Phase 3

Conditions

Leishmaniasis, Cutaneous

Treatments

Drug: Oral doxycycline

Drug: Intralesional Sodium stibogluconate

Procedure: Intralesional Cryotherapy

Drug: Intralesional Voriconazole

Study type

Interventional

Funder types

Other

Identifiers

NCT05708625

ZU-IRB#8095/3-10-2021

Details and patient eligibility

About

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).

Full 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:

To evaluate the effectiveness and safety of intralesional Voriconazole comparing it to the intralesional SSG in patients with CL.
To evaluate the effectiveness and safety of intralesional cryotherapy comparing it to the intralesional SSG in patients with CL.
To evaluate the effectiveness and safety of Oral doxycycline comparing it to the intralesional SSG in patients with CL.

Enrollment

136 estimated patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

136 participants in 4 patient groups

Intralesional Sodium stibogluconate

Active Comparator group

Description:

Patients will receive intralesional infiltration of (SSG) at a dose of 50 mg/0.5 ml (0.2-0.4ml) maximum dose per session 1-3 ml. Sessions will be held once weekly for a maximum of 6 weeks.

Treatment:

Drug: Intralesional Sodium stibogluconate

intralesional Cryotherapy

Experimental group

Description:

Patients will be treated with intralesional Cryotherapy. Sessions will be held every two weeks till complete cure or a maximum of 6 sessions

Treatment:

Procedure: Intralesional Cryotherapy

Intralesional Voriconazole

Experimental group

Description:

Patients will be treated with intralesional Voriconazole weekly till complete cure or a maximum of 6 sessions