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

Parizi, Mohammad Hossein Daie; Karvar, Mehran; Sharifi, Iraj; Bahrampour, Abbas; Khah, Amireh Heshmat; Rahnama, Zahra; Baziar, Zahra; Amiri, Rahebeh

doi:10.1111/dth.12229

Cited by 14 publications

(11 citation statements)

References 9 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…2009 , El-Sayed & Anwar 2010 , Kashani et al 2010 , Van Thiel et al 2010 , Meymandi et al 2011 , Safi et al. 2012 , Bumb et al 2013 , Khatami et al 2013 , Mohammedzadh et al 2013 , Soto et al 2013 , Dieterle & Pillekamp 2014 , Stahl et al 2014 , Banihashemi et al 2015 , Parizi et al 2015 , Ranawaka et al. 2015 ) clinical trials addressing intralesional therapy over the last 10 years were identified.…”

Section: Resultsmentioning

confidence: 99%

Towards a standard protocol for antimony intralesional infiltration technique for cutaneous leishmaniasis treatment

Silva

Carvalho

Ramalho

et al. 2018

Mem. Inst. Oswaldo Cruz

View full text Add to dashboard Cite

BACKGROUNDDespite its recognised toxicity, antimonial therapy continues to be the first-line drug for cutaneous leishmaniasis (CL) treatment. Intralesional administration of meglumine antimoniate (MA) represents an alternative that could reduce the systemic absorption of the drug and its side effects.OBJECTIVESThis study aims to validate the standard operational procedure (SOP) for the intralesional infiltration of MA for CL therapy as the first step before the assessment of efficacy and safety related to the procedure.METHODSThe SOP was created based on 21 trials retrieved from the literature, direct monitoring of the procedure and consultation with experts. This script was submitted to a formal computer-aided inspection to identify readability, clarity, omission, redundancy and unnecessary information (content validation). For criterion and construct validations, the influence of critical condition changes (compliance with the instructions and professional experience) on outcome conformity (saturation status achievement), tolerability (pain referred) and safety (bleeding) were assessed.FINDINGSThe median procedure length was 12 minutes and in 72% of them, patients classified the pain as mild. The bleeding was also classified as mild in 96.6% of the procedures. Full compliance with the SOP was observed in 66% of infiltrations. Despite this, in 100% of the inspected procedures, lesion saturation was observed at the end of infiltration, which means that it tolerates some degree of modification in its execution (robustness) without prejudice to the result.CONCLUSIONSThe procedure is reproducible and can be used by professionals without previous training with high success and safety rates.

show abstract

Section: Resultsmentioning

confidence: 99%

Towards a standard protocol for antimony intralesional infiltration technique for cutaneous leishmaniasis treatment

Silva

Carvalho

Ramalho

et al. 2018

Mem. Inst. Oswaldo Cruz

View full text Add to dashboard Cite

show abstract

“…Sex was considered an inclusion criterion in 94.3% ( n = 100) of studies enrolling 11 081 patients; 87.7% ( n = 93) enrolled participants of both sexes , seven studies (6.6%) enrolled only men ; in five studies (4.7%), although sex was not specified in the inclusion criteria, inclusions can be derived from the results , and one study did not refer to the sex of the participants (Table ). For pregnancy and lactation, see Exclusion criteria below (Table ).…”

Section: Resultsmentioning

confidence: 99%

“…Type of lesions was considered in 13.2% ( n = 14) of studies; all included ulcerated lesions, but while nine (64.3%) also allowed all other types of lesions, five (35.7%) restricted inclusions to ulcers. Of note, one study limited enrolment to ulcerated lesions for only one of the two topical treatment groups (local application of liquid solution composed of thioxolone and 3 mg benzoxonium chloride + cryotherapy) (Table ) .…”

Section: Resultsmentioning

confidence: 99%

Eligibility criteria and outcome measures adopted in clinical trials of treatments of cutaneous leishmaniasis: systematic literature review covering the period 1991–2015

López-Carvajal

Vélez

Arbeláez

et al. 2018

Tropical Med Int Health

View full text Add to dashboard Cite

Abstractobjective To document the sources of heterogeneity in outcomes and shortcomings in trial designs reported by previous systematic reviews.methods Systematic review of clinical trials of CL treatments published since 1991, to assess and compare eligibility criteria and outcome measures in trials (any type of treatment) of CL (any form) reported before and after the publication of the CONSORT statement.results We identified 106 eligible trials published between 1991 and 2015, 74% after the 2001 CONSORT statement; 58% (n = 63) were on Old-World CL and 37% (n = 40) in New-World CL; overall, 11 531 patients enrolled in 243 treatment groups on 30 different treatments. Both requirements and definitions for eligibility and outcome criteria varied. Compliance with CONSORT requirements increased for studies published after the 2010 update. As for entry criteria, 94% of studies had a requirement for sex (74% of those enrolling also women excluded those who were pregnant or lactating), 69% for age (variable age ranges), 99% parasitological confirmation, 43% prior duration of illness (14% excluded cases with previous episodes), 46% defined the number, 28% the size and 13% the type of lesions (27% with restrictions as to their anatomical location). Follow-up ranged 1-24 months, with 14% and 91% of studies, respectively, having defined initial and final cure.conclusions This review documents changes in reporting before and after the publication of the CONSORT statement. Lack of standardisation, compounded with the small number of trials relative to the magnitude of the disease in its multiple forms, and with the range of treatments tested explains why evidence to inform treatment guidelines is generally weak for CL. Adopting standardised methodologies will improve the quality and consistency of clinical trials, and ultimately yield better treatments for CL.

show abstract

“…Niosomes have potential as new and selective drugs for treating important diseases, including leishmaniasis (Kazi et al 2010). Previous studies have evaluated the anti-leishmanial effects of Thio-Ben on patients (Daie Parizi et al 2015) and in the present work, we evaluated the in vitro leishmanicidal effects of benzoxonium chloride (one of the components of Thio-Ben) and its niosomal forms against different forms of the parasite ( L. tropica ).…”

Section: Discussionmentioning

confidence: 99%

“…However, studies have suggested that benzoxonium chloride inhibits certain bacterial enzymes ([CSL STYLE ERROR: reference with no printed form.]). In 2015, Thio-Ben was tested in a clinical trial and it evaluated the efficacy of the topical use of tioxolone plus benzoxonium chloride (Thio-Ben) tincture in combination with cryotherapy as compared to intralesional meglumine antimoniate (glucantime™) along with cryotherapy in treating anthroponotic CL (ACL) (Daie Parizi et al 2015). The study reported that the topical use of Thio-Ben combined with cryotherapy showed good efficacy in treating ACL along with benefits pertaining to more patient compliance and less side effects than intralesional glucantime (Daie Parizi et al 2015).…”

Section: Introductionmentioning

confidence: 99%

Antileishmanial activity and immune modulatory effects of benzoxonium chloride and its entrapped forms in niosome on Leishmania tropica

et al. 2019

Self Cite

View full text Add to dashboard Cite

Benzoxonium chloride is an anti-infective agent that is used as anti-septic drugs for disinfection of the mucus membrane, skin surface and anti-bacterial, and it is also found to be effective against cutaneous leishmaniasis. The present study aims to evaluate the leishmanicidal activity of benzoxonium chloride and niosomal forms against Leishmania tropica stages. Benzoxonium chloride niosomes were prepared by the thin film hydration method and evaluated for morphology, particle size and release study and encapsulation efficiency. This study measured the cytotoxicity, leishmanicidal activity against promastigote and intra macrophage amastigote, apoptosis, and mRNA transcripts by quantitative real time PCR (qPCR) of free solution and niosomal-encapsulated benzoxonium chloride. Span/Tween 60 niosomal formulation of benzoxonium chloride showed superior physical stability and high encapsulation efficiency (96%) than the other forms. Release from the formulations showed that the Span/Tween 60 containing drug had a milder gradient so that 10% of the drug was not released after 4 h. The benzoxonium chloride and niosomal forms inhibited the in vitro growth of promastigote and amastigote forms of L. tropica after 48 h of incubation and represented IC 50 values of 90.7 ± 2.7 and 25.4 ± 0.6 μg/ mL, respectively. The rate of apoptosis in niosomal formulations was approximately equal to the positive control (meglumine antimoniate) at the same concentration. Also, an increase in the concentration of this drug reduced the expression of IL-10, but increased the expression of IL-12. The niosomal formulations provided improved anti-leishmanial activities of benzoxonium chloride and played an immunomodulatory role as the mode of action in the treatment of anthroponotic CL.

show abstract

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

Cited by 14 publications

References 9 publications

Towards a standard protocol for antimony intralesional infiltration technique for cutaneous leishmaniasis treatment

Towards a standard protocol for antimony intralesional infiltration technique for cutaneous leishmaniasis treatment

Eligibility criteria and outcome measures adopted in clinical trials of treatments of cutaneous leishmaniasis: systematic literature review covering the period 1991–2015

Antileishmanial activity and immune modulatory effects of benzoxonium chloride and its entrapped forms in niosome on Leishmania tropica

Contact Info

Product

Resources

About