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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).
So in this study the following objectives are being aimed:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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 |
|
| Intralesional Voriconazole | Experimental | Patients will be treated with intralesional Voriconazole weekly till complete cure or a maximum of 6 sessions |
|
| Oral doxycycline | Experimental | Patients will be treated with oral doxycycline, 200 mg daily, until complete cure or a maximum of 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intralesional Sodium stibogluconate | Drug | Sessions will be held once weekly for a maximum of 6 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Persistence of clinical response | Persistence of clinical response at the end of follow-up period | 12 week post treatment termination |
| Patient compliance | The percentage of patients continued the study in each arm |
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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.
Exclusion Criteria:
• Pregnancy and lactation.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hagar Nofal, Dr. | Contact | 01006387707 | hagarnofal@aucegypt.edu |
| Name | Affiliation | Role |
|---|---|---|
| Hagar Nofal, Dr | Zagazig University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatology department, Gharyan University Hospitals, Medical College, Gharyan University | Recruiting | Gharyan | Select Region | Libya |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33190654 | Background | 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. | |
| 15090013 | 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. |
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| Intralesional Cryotherapy | Procedure | Intralesional Cryotherapy. Sessions will be held every two weeks |
|
| Intralesional Voriconazole | Drug | Weekly intralesional Voriconazole |
|
|
| Oral doxycycline | Drug | 200 mg daily for 6 weeks or till complete cure |
|
| 6 weeks |
| 33637428 | 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. |
| 25847678 | 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. |
| 23390069 | 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. |
| ID | Term |
|---|---|
| D016773 | Leishmaniasis, Cutaneous |
| ID | Term |
|---|---|
| D007896 | Leishmaniasis |
| D056986 | Euglenozoa Infections |
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D012876 | Skin Diseases, Parasitic |
| D000079426 | Vector Borne Diseases |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D065819 | Voriconazole |
| D004318 | Doxycycline |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
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