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

NCT05708625 | Unknown Phase 3

• 1 other identifier: ZU-IRB#8095/3-10-2021
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

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).

Conditions

Leishmaniasis, Cutaneous

Outcome Measures

Primary Outcomes (1)

• Clinical response to treatment

  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

  6 weeks

Secondary Outcomes (2)

• Persistence of clinical response

  12 week post treatment termination

• Patient compliance

  6 weeks

Study Arms (4)

Intralesional Sodium stibogluconate

ACTIVE COMPARATOR

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

intralesional Cryotherapy

EXPERIMENTAL

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 Voriconazole

EXPERIMENTAL

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

Drug: Intralesional Voriconazole

Oral doxycycline

EXPERIMENTAL

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

Drug: Oral doxycycline

Interventions

Intralesional Sodium stibogluconate DRUG

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

Also known as: SSG

Intralesional Sodium stibogluconate

Intralesional Cryotherapy PROCEDURE

Intralesional Cryotherapy. Sessions will be held every two weeks

intralesional Cryotherapy

Intralesional Voriconazole DRUG

Weekly intralesional Voriconazole

Also known as: Vfend

Intralesional Voriconazole

Oral doxycycline DRUG

200 mg daily for 6 weeks or till complete cure

Oral doxycycline

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Dermatology department, Gharyan University Hospitals, Medical College, Gharyan University

Gharyan, Select Region, Libya

RECRUITING

Related Publications (5)

• Akulinina IK, Berechikidze IA, Larina SN, Sakharova TV, Degtyarevskaya TY, Romanelli M. Effectiveness of doxycycline for the treatment of zoonotic cutaneous leishmaniasis in vivo. Parasitology. 2021 Mar;148(3):361-365. doi: 10.1017/S0031182020002152. Epub 2020 Nov 16.

  PMID: 33190654 BACKGROUND

• Asilian A, Sadeghinia A, Faghihi G, Momeni A. Comparative study of the efficacy of combined cryotherapy and intralesional meglumine antimoniate (Glucantime) vs. cryotherapy and intralesional meglumine antimoniate (Glucantime) alone for the treatment of cutaneous leishmaniasis. Int J Dermatol. 2004 Apr;43(4):281-3. doi: 10.1111/j.1365-4632.2004.02002.x.

  PMID: 15090013 BACKGROUND

• Bahrami S, Oryan A, Bemani E. Efficacy of amiodarone and voriconazole combination therapy in cutaneous leishmaniasis in the mice experimentally infected with Leishmania major. J Infect Chemother. 2021 Jul;27(7):984-990. doi: 10.1016/j.jiac.2021.02.011. Epub 2021 Feb 23.

  PMID: 33637428 BACKGROUND

• Daie Parizi MH, Karvar M, Sharifi I, Bahrampour A, Heshmat Khah A, Rahnama Z, Baziar Z, Amiri R. The topical treatment of anthroponotic cutaneous leishmaniasis with the tincture of thioxolone plus benzoxonium chloride (Thio-Ben) along with cryotherapy: a single-blind randomized clinical trial. Dermatol Ther. 2015 May-Jun;28(3):140-6. doi: 10.1111/dth.12229. Epub 2015 Apr 6.

  PMID: 25847678 BACKGROUND

• Soto J, Rojas E, Guzman M, Verduguez A, Nena W, Maldonado M, Cruz M, Gracia L, Villarroel D, Alavi I, Toledo J, Berman J. Intralesional antimony for single lesions of bolivian cutaneous leishmaniasis. Clin Infect Dis. 2013 May;56(9):1255-60. doi: 10.1093/cid/cit049. Epub 2013 Feb 6.

  PMID: 23390069 BACKGROUND

MeSH Terms

Conditions

Leishmaniasis, Cutaneous

Interventions

Voriconazole; Doxycycline

Condition Hierarchy (Ancestors)

Leishmaniasis; Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Skin Diseases, Parasitic; Vector Borne Diseases; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Hagar Nofal, Dr

  Zagazig University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hagar Nofal, Dr.

CONTACT

01006387707; hagarnofal@aucegypt.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: January 22, 2023
• First Posted: February 1, 2023
• Study Start: January 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: March 1, 2024
• Last Updated: August 29, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

LI (1)