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

Sponsor

Zagazig University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05708625

Collaborator

(none)

136

Enrollment

Location

Arms

Anticipated Duration (Months)

6.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Leishmaniasis, Cutaneous	Drug: Intralesional Sodium stibogluconate Procedure: Intralesional Cryotherapy Drug: Intralesional Voriconazole Drug: Oral doxycycline	Phase 3

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:

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

136 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Feb 1, 2023

Anticipated Study Completion Date :

Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Drug: Intralesional Sodium stibogluconate Sessions will be held once weekly for a maximum of 6 weeks Other Names: SSG
Experimental: 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	Procedure: Intralesional Cryotherapy Intralesional Cryotherapy. Sessions will be held every two weeks
Experimental: Intralesional Voriconazole Patients will be treated with intralesional Voriconazole weekly till complete cure or a maximum of 6 sessions	Drug: Intralesional Voriconazole Weekly intralesional Voriconazole Other Names: Vfend
Experimental: Oral doxycycline Patients will be treated with oral doxycycline, 200 mg daily, until complete cure or a maximum of 6 weeks	Drug: Oral doxycycline 200 mg daily for 6 weeks or till complete cure

Outcome Measures

Primary Outcome Measures

Clinical response to treatment [6 weeks]
The responses will be graded by an investigator who don't perform the injections. The clinical response will be graded based on the improvement percentage of the lesion in terms of size, erythema, inflammation, edema and ulcer re-epithelialization

Secondary Outcome Measures

Persistence of clinical response [12 week post treatment termination]
Persistence of clinical response at the end of follow-up period
Patient compliance [6 weeks]
The percentage of patients continued the study in each arm

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Patients clinically diagnosed with cutaneous leishmaniasis and confirmed using parasitological Giemsa-stained direct smears.
Acute lesions of less than 12-week duration to exclude any possibility of natural self-healing of the lesions during follow-up.
Both sexes.
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dermatology department, Gharyan University Hospitals, Medical College, Gharyan University	Gharyan	Select Region	Libyan Arab Jamahiriya

Sponsors and Collaborators

Zagazig University

Investigators

Principal Investigator: Hagar Nofal, Dr, Zagazig University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Hagar Nofal, Clinical Professor, Zagazig University

ClinicalTrials.gov Identifier:

NCT05708625

Other Study ID Numbers:

ZU-IRB#8095/3-10-2021

First Posted:

Feb 1, 2023

Last Update Posted:

Feb 1, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Leishmaniasis

Leishmaniasis, Cutaneous

Doxycycline

Voriconazole

Antimony Sodium Gluconate

Study Results

No Results Posted as of Feb 1, 2023