Back to resultsIntralesional Voriconazole, or Intralesional Cryotherapy, or Oral Doxycycline in the Treatment of Cutaneous Leishmaniasis
Primary Purpose
Leishmaniasis, Cutaneous
Status
Recruiting
Phase
Phase 3
Locations
Libyan Arab Jamahiriya
Study Type
Interventional
Intervention
Intralesional Sodium stibogluconate
Intralesional Cryotherapy
Intralesional Voriconazole
Oral doxycycline
Sponsored by
About this trial
This is an interventional treatment trial for Leishmaniasis, Cutaneous
Eligibility 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. 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.
Sites / Locations
- Dermatology department, Gharyan University Hospitals, Medical College, Gharyan UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Experimental
Experimental
Experimental
Arm Label
Intralesional Sodium stibogluconate
intralesional Cryotherapy
Intralesional Voriconazole
Oral doxycycline
Arm 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.
Patients will be treated with intralesional Cryotherapy. Sessions will be held every two weeks till complete cure or a maximum of 6 sessions
Patients will be treated with intralesional Voriconazole weekly till complete cure or a maximum of 6 sessions
Patients will be treated with oral doxycycline, 200 mg daily, until complete cure or a maximum of 6 weeks
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Persistence of clinical response
Persistence of clinical response at the end of follow-up period
Patient compliance
The percentage of patients continued the study in each arm
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05708625
Brief Title
Intralesional Voriconazole, or Intralesional Cryotherapy, or Oral Doxycycline in the Treatment of Cutaneous Leishmaniasis
Official Title
Efficacy of Intralesional Voriconazole Versus Intralesional Cryotherapy Versus Intralesional Sodium Stibogluconate Versus Oral Doxycycline in the Treatment of Acute Cutaneous Leishmaniasis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leishmaniasis, Cutaneous
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
136 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intralesional Sodium stibogluconate
Arm Type
Active Comparator
Arm 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.
Arm Title
intralesional Cryotherapy
Arm Type
Experimental
Arm Description
Patients will be treated with intralesional Cryotherapy. Sessions will be held every two weeks till complete cure or a maximum of 6 sessions
Arm Title
Intralesional Voriconazole
Arm Type
Experimental
Arm Description
Patients will be treated with intralesional Voriconazole weekly till complete cure or a maximum of 6 sessions
Arm Title
Oral doxycycline
Arm Type
Experimental
Arm Description
Patients will be treated with oral doxycycline, 200 mg daily, until complete cure or a maximum of 6 weeks
Intervention Type
Drug
Intervention Name(s)
Intralesional Sodium stibogluconate
Other Intervention Name(s)
SSG
Intervention Description
Sessions will be held once weekly for a maximum of 6 weeks
Intervention Type
Procedure
Intervention Name(s)
Intralesional Cryotherapy
Intervention Description
Intralesional Cryotherapy. Sessions will be held every two weeks
Intervention Type
Drug
Intervention Name(s)
Intralesional Voriconazole
Other Intervention Name(s)
Vfend
Intervention Description
Weekly intralesional Voriconazole
Intervention Type
Drug
Intervention Name(s)
Oral doxycycline
Intervention Description
200 mg daily for 6 weeks or till complete cure
Primary Outcome Measure Information:
Title
Clinical response to treatment
Description
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
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Persistence of clinical response
Description
Persistence of clinical response at the end of follow-up period
Time Frame
12 week post treatment termination
Title
Patient compliance
Description
The percentage of patients continued the study in each arm
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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.
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hagar Nofal, Dr.
Phone
01006387707
Email
hagarnofal@aucegypt.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hagar Nofal, Dr
Organizational Affiliation
Zagazig University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dermatology department, Gharyan University Hospitals, Medical College, Gharyan University
City
Gharyan
State/Province
Select Region
Country
Libyan Arab Jamahiriya
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hagar Nofal, Dr.
Phone
01006387707
Email
hagarnofal@aucegypt.edu
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
33190654
Citation
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.
Results Reference
background
PubMed Identifier
15090013
Citation
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.
Results Reference
background
PubMed Identifier
33637428
Citation
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.
Results Reference
background
PubMed Identifier
25847678
Citation
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.
Results Reference
background
PubMed Identifier
23390069
Citation
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.
Results Reference
background
Learn more about this trial
Intralesional Voriconazole, or Intralesional Cryotherapy, or Oral Doxycycline in the Treatment of Cutaneous Leishmaniasis
We'll reach out to this number within 24 hrs