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Tytuł:
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Salvage therapy with Sodium chlorosum (formerly DAC N-055) for cases of refractory lupoid cutaneous leishmaniasis: results from a compassionate use study with 0.09% Sodium chlorosum in amphiphilic basic cream.
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Autorzy:
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Molkara S; Cutaneous Leishmaniasis Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.
Poursoltani E; Cutaneous Leishmaniasis Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.
Stahl KW; Waisenmedizin e. V. Promoting Access to Care with Essential Medicine (PACEM), Non-Profit Non-Governmental Organization, Freiburg, Germany. .
Maleki M; Cutaneous Leishmaniasis Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.
Khamesipour A; Center for Research and Training in Skin Diseases and Leprosy, Tehran University of Medical Sciences, Tehran, Iran.
Bogdan C; Mikrobiologisches Institut - Klinische Mikrobiologie, Immunologie und Hygiene, Friedrich-Alexander-Universität (FAU) Erlangen-Nürnberg und Universitätsklinikum Erlangen, Erlangen, Germany.
Salehi M; Community Medicine Department, Faculty of Medicine and Clinical Research Unit, Ghaem Hospital, Mashhad University of Medical Sciences, Mashhad, Iran.
Goyonlo VM; Cutaneous Leishmaniasis Research Center, Mashhad University of Medical Sciences, Mashhad, Iran. .
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Źródło:
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BMC infectious diseases [BMC Infect Dis] 2019 Nov 28; Vol. 19 (1), pp. 1005. Date of Electronic Publication: 2019 Nov 28.
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Typ publikacji:
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Clinical Trial; Journal Article
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Język:
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English
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Imprint Name(s):
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Original Publication: London : BioMed Central, [2001-
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MeSH Terms:
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Chlorides/*therapeutic use
Leishmaniasis, Cutaneous/*drug therapy
Administration, Topical ; Adolescent ; Adult ; Child ; Child, Preschool ; Chlorides/adverse effects ; Drug Resistance ; Erythema/etiology ; Female ; Humans ; Iran ; Leishmaniasis, Cutaneous/therapy ; Male ; Middle Aged ; Salvage Therapy ; Skin Cream/adverse effects ; Skin Cream/chemistry ; Skin Cream/therapeutic use ; Treatment Outcome ; Young Adult
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References:
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Onkologie. 1988 Oct;11(5):238-40. (PMID: 3059251)
J Infect Public Health. 2016 Sep-Oct;9(5):557-63. (PMID: 26796767)
Dermatol Online J. 2006 Feb 28;12(2):3. (PMID: 16638396)
Lancet. 1986 Apr 12;1(8485):825-8. (PMID: 2870315)
Front Cell Infect Microbiol. 2012 May 29;2:69. (PMID: 22919660)
BMJ Open. 2018 Jun 15;8(6):e021372. (PMID: 29909372)
Parasite Immunol. 2018 Jan;40(1):. (PMID: 29205403)
Dermatology. 2008;216(2):187-9. (PMID: 18216488)
Front Immunol. 2018 Jan 24;9:24. (PMID: 29472914)
Z Naturforsch C J Biosci. 1988 Nov-Dec;43(11-12):893-902. (PMID: 3245879)
Iran J Pathol. 2017 Spring;12(2):119-127. (PMID: 29515633)
Radiat Res. 1994 Aug;139(2):226-31. (PMID: 8052699)
Int J Dermatol. 2006 Aug;45(8):989-91. (PMID: 16911395)
PLoS Negl Trop Dis. 2014 Feb 13;8(2):e2694. (PMID: 24551257)
Dermatol Clin. 2015 Jul;33(3):579-93. (PMID: 26143433)
Drugs Exp Clin Res. 1993;19(4):165-74. (PMID: 8131712)
BMC Infect Dis. 2014 Nov 25;14:619. (PMID: 25420793)
Agents Actions. 1990 Nov;31(3-4):368-74. (PMID: 1964762)
Arch Iran Med. 2009 Jul;12(4):371-6. (PMID: 19566354)
Arch Dermatol Res. 2014 Mar;306(2):181-8. (PMID: 23989888)
Radiat Res. 1988 Jul;115(1):115-23. (PMID: 3293099)
Kinetoplastid Biol Dis. 2007 Apr 24;6:3. (PMID: 17456237)
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Grant Information:
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931617 Mashhad University of Medical Sciences
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Contributed Indexing:
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Keywords: Lupoid cutaneous leishmaniasis; Sodium chlorosum (formerly DAC N-055); Treatment
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Substance Nomenclature:
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0 (Chlorides)
Z63H374SB6 (chlorite)
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Entry Date(s):
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Date Created: 20191130 Date Completed: 20200107 Latest Revision: 20200108
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Update Code:
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20240104
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PubMed Central ID:
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PMC6883658
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DOI:
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10.1186/s12879-019-4518-x
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PMID:
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31779597
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Background: Lupoid cutaneous leishmaniasis (LCL) is known as a rare but serious complication of anthroponotic cutaneous leishmaniasis (ACL) resistant to conventional treatments. Sodium chlorosum, a pro-oxidative preparation of pharmaceutical sodium chlorite (NaClO 2 ), has been successfully used for the treatment of Old World cutaneous leishmaniasis lesions (OWCL) and of some LCL cases in Afghanistan. This clinical trial study aimed to evaluate the effect of a last resort therapy with topical 0.09% sodium chlorosum on LCL in Iran.
Methods: Twenty Iranian patients (12 women and 8 men) with LCL refractory to treatment were included in this salvage study. A magistral preparation of sodium chlorosum (10 mM NaClO 2 in amphiphilic basic cream) was applied twice daily to the lesions for 6 weeks and continued up to 12 weeks in patients who showed a clinical response within the first 6 weeks. Responders were followed up for a maximum of 1 year. Lesions were photographed during weekly visits. Disappearance of erythema and indurated lesions were rated as complete clinical response.
Results: Patients with a mean age of 28.6 (±24.3) and with an ACL proven lesion history of 3.8 (±1.4) years were treated for an average of 7.9 (±1.8) weeks. At the end of the treatment period (12th week), a complete response was observed in 9 of 20 patients (45%). During the one-year follow-up period, LCL lesions recurred in 4 of these 9 patients (with one patient showing only a tiny lesion) and one case lost to follow up whereas the other four remained completely lesion-free. Mild temporary side-effects such as erythema and itching were seen in 4 of 20 patients (20%).
Conclusions: Topical sodium chlorosum showed promising therapeutic results and can be considered as safe, painless, and relatively effective treatment for LCL, an ethical prerequisite for a two-armed controlled trial.
Trial Registration: This study was registered in Iranian registry of clinical trials on 2019-02-02 with registration number IRCT20190114042356N1.
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