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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2024-03-01

Brief Summary

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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).

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Detailed Description

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* 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

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Leishmaniasis, Cutaneous

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Intralesional Sodium stibogluconate

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.

Group Type ACTIVE_COMPARATOR

Intralesional Sodium stibogluconate

Intervention Type DRUG

Sessions will be held once weekly for a maximum of 6 weeks

intralesional Cryotherapy

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

Group Type EXPERIMENTAL

Intralesional Cryotherapy

Intervention Type PROCEDURE

Intralesional Cryotherapy. Sessions will be held every two weeks

Intralesional Voriconazole

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

Group Type EXPERIMENTAL

Intralesional Voriconazole

Intervention Type DRUG

Weekly intralesional Voriconazole

Oral doxycycline

Patients will be treated with oral doxycycline, 200 mg daily, until complete cure or a maximum of 6 weeks

Group Type EXPERIMENTAL

Oral doxycycline

Intervention Type DRUG

200 mg daily for 6 weeks or till complete cure

Interventions

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Intralesional Sodium stibogluconate

Sessions will be held once weekly for a maximum of 6 weeks

Intervention Type DRUG

Intralesional Cryotherapy

Intralesional Cryotherapy. Sessions will be held every two weeks

Intervention Type PROCEDURE

Intralesional Voriconazole

Weekly intralesional Voriconazole

Intervention Type DRUG

Oral doxycycline

200 mg daily for 6 weeks or till complete cure

Intervention Type DRUG

Other Intervention Names

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SSG Vfend

Eligibility Criteria

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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.

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No