{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,20]],"date-time":"2026-09-20T03:42:33Z","timestamp":1789875753154,"version":"4.0.1"},"reference-count":28,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2015,1,20]],"date-time":"2015-01-20T00:00:00Z","timestamp":1421712000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Int J Dermatology"],"published-print":{"date-parts":[[2015,5]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Intralesional 7% hypertonic saline (<jats:styled-content style=\"fixed-case\">HS<\/jats:styled-content>) has been shown to be effective and safe against <jats:italic>Leishmania donovani<\/jats:italic> and <jats:italic>Leishmania major<\/jats:italic> cutaneous leishmaniasis (<jats:styled-content style=\"fixed-case\">CL<\/jats:styled-content>), with cure rates of 92% and 96%, respectively. This study was designed to assess the efficacy and safety of 10% and 15% <jats:styled-content style=\"fixed-case\">HS<\/jats:styled-content> in <jats:styled-content style=\"fixed-case\">CL<\/jats:styled-content>.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>A total of 444 patients (643 lesions) were randomly allocated to sodium stibogluconate (<jats:styled-content style=\"fixed-case\">SSG<\/jats:styled-content>), 10% <jats:styled-content style=\"fixed-case\">HS<\/jats:styled-content> and 15% <jats:styled-content style=\"fixed-case\">HS<\/jats:styled-content> at a ratio of 2\u00a0:\u00a02\u00a0:\u00a01, taking into consideration any unwanted side effects that might arise with 15% <jats:styled-content style=\"fixed-case\">HS<\/jats:styled-content>. The follow\u2010up period was 18\u00a0months. Survival analysis using Cox proportional hazard regression was performed to assess the effectiveness of the three treatment modalities. The clinical trial was registered at the Sri Lanka Clinical Trial Registry (<jats:styled-content style=\"fixed-case\">SLCTR<\/jats:styled-content>\/2013\/024).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Treatment with <jats:styled-content style=\"fixed-case\">SSG<\/jats:styled-content> resulted in a cure rate of 96.3% within one to seven injections (mean: 3.6 injections); the mean (median) duration of treatment was six\u00a0weeks (6\u00a0weeks) per lesion. Treatment with 10% <jats:styled-content style=\"fixed-case\">HS<\/jats:styled-content> showed a cure rate of 93.0% within one to 10 injections (mean: 5.28 injections); the mean (median) duration of treatment was 9.3\u00a0weeks (9\u00a0weeks) per lesion. Treatment with 15% <jats:styled-content style=\"fixed-case\">HS<\/jats:styled-content> showed a cure rate of 93.6% within two to 10 injections (mean: 5.3 injections); the mean (median) duration of treatment was 11.3\u00a0weeks (10.0\u00a0weeks) per lesion. Treatment with 10% <jats:styled-content style=\"fixed-case\">HS<\/jats:styled-content> and 15% <jats:styled-content style=\"fixed-case\">HS<\/jats:styled-content> caused cutaneous necrosis in 3.1% and 30.6% of lesions, respectively. Despite continuous data collection for 14\u00a0months, we were unable to recruit a sample of sufficient size. Seventeen (3.8%) patients were lost to follow\u2010up, and 24 (5.4%) were partial or non\u2010responders.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>This study found 10% HS to be an effective and safe alternative to SSG. Treatment with HS at concentrations of 15% or above was not safe as a result of cutaneous necrosis. Safety was not studied for concentrations of 11\u201314%, and these concentrations should be avoided pending further evidence. Hypertonic saline is very cheap (&lt;\u00a0US$1 per 100\u00a0ml, whereas SSG is priced at US$160 per 100\u00a0ml), is prepared locally and has no systemic side effects and minimal local side effects.<\/jats:p><\/jats:sec>","DOI":"10.1111\/ijd.12685","type":"journal-article","created":{"date-parts":[[2015,1,20]],"date-time":"2015-01-20T08:44:36Z","timestamp":1421743476000},"page":"555-563","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":20,"title":["Randomized, double\u2010blind, controlled, comparative study on intralesional 10% and 15% hypertonic saline versus intralesional sodium stibogluconate in <i><scp>L<\/scp>eishmania donovani<\/i> cutaneous leishmaniasis"],"prefix":"10.1111","volume":"54","author":[{"given":"Ranthilaka R.","family":"Ranawaka","sequence":"first","affiliation":[{"name":"Department of Dermatology Anuradhapura Teaching Hospital Anuradhapura Sri Lanka"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hema S.","family":"Weerakoon","sequence":"additional","affiliation":[{"name":"Department of Dermatology Anuradhapura Teaching Hospital Anuradhapura Sri Lanka"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2416-3547","authenticated-orcid":false,"given":"S. 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Padmal","family":"de Silva","sequence":"additional","affiliation":[{"name":"Department of Evaluation and Research National Institute of Health Sciences Kalutara Sri Lanka"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2015,1,20]]},"reference":[{"key":"e_1_2_6_2_1","first-page":"262","article-title":"Leishmania donovani in Ceylon","volume":"10","author":"Castellani A","year":"1904","journal-title":"J Trop Med"},{"key":"e_1_2_6_3_1","first-page":"1110","article-title":"Visceral leishmaniasis in an English girl","volume":"66","author":"Chapman RL","year":"1973","journal-title":"Proc R Soc Med"},{"key":"e_1_2_6_4_1","first-page":"432","article-title":"Locally acquired cutaneous leishmaniasis in Sri Lanka","volume":"95","author":"Athkorala DN","year":"1992","journal-title":"J Trop Med Hyg"},{"key":"e_1_2_6_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0035-9203(03)90061-7"},{"key":"e_1_2_6_6_1","first-page":"90","article-title":"First report of mucosal tissue localization of leishmaniasis in Sri Lanka","volume":"50","author":"Rajapaksa US","year":"2005","journal-title":"Ceylon Med J"},{"key":"e_1_2_6_7_1","doi-asserted-by":"publisher","DOI":"10.4038\/cmj.v52i1.1047"},{"key":"e_1_2_6_8_1","doi-asserted-by":"publisher","DOI":"10.4038\/cmj.v56i4.3904"},{"key":"e_1_2_6_9_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2133.1988.tb07100.x"},{"key":"e_1_2_6_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2133.2010.09865.x"},{"key":"e_1_2_6_11_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pntd.0000628"},{"key":"e_1_2_6_12_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1468-3083.2009.03417.x"},{"key":"e_1_2_6_13_1","doi-asserted-by":"publisher","DOI":"10.3109\/09546631003762654"},{"key":"e_1_2_6_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaad.2007.12.032"},{"key":"e_1_2_6_15_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1346-8138.1995.tb03911.x"},{"key":"e_1_2_6_16_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2230.1997.tb01054.x"},{"key":"e_1_2_6_17_1","doi-asserted-by":"publisher","DOI":"10.3109\/09546630903287445"},{"key":"e_1_2_6_18_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(05)66516-6"},{"key":"e_1_2_6_19_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.trstmh.2006.05.013"},{"key":"e_1_2_6_20_1","first-page":"4","article-title":"Leishmaniasis in the North Central Province Sri Lanka \u2013 epidemiology and therapeutic response","volume":"14","author":"Ranawaka RR","year":"2010","journal-title":"Sri Lanka J Dermatol"},{"key":"e_1_2_6_21_1","volume-title":"The Leishmaniases: Report of a WHO Expert Committee","author":"World Health Organization","year":"1984"},{"key":"e_1_2_6_22_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-4362.1993.tb05044.x"},{"key":"e_1_2_6_23_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-4362.1996.tb03669.x"},{"key":"e_1_2_6_24_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365-3156.2001.00778.x"},{"key":"e_1_2_6_25_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaad.2009.06.044"},{"key":"e_1_2_6_26_1","doi-asserted-by":"publisher","DOI":"10.1590\/S0037-86822012000100027"},{"key":"e_1_2_6_27_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00436-011-2555-5"},{"key":"e_1_2_6_28_1","first-page":"65","article-title":"Socio\u2010environmental factors and sandfly prevalence in Delft Island, Sri Lanka: implications for leishmaniasis vector control","volume":"44","author":"Surendran SN","year":"2007","journal-title":"J Vector Borne Dis"},{"key":"e_1_2_6_29_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijid.2008.08.023"}],"container-title":["International Journal of Dermatology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fijd.12685","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/ijd.12685","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,10,3]],"date-time":"2023-10-03T06:38:41Z","timestamp":1696315121000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/ijd.12685"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2015,1,20]]},"references-count":28,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2015,5]]}},"alternative-id":["10.1111\/ijd.12685"],"URL":"https:\/\/doi.org\/10.1111\/ijd.12685","archive":["Portico"],"relation":{},"ISSN":["0011-9059","1365-4632"],"issn-type":[{"value":"0011-9059","type":"print"},{"value":"1365-4632","type":"electronic"}],"subject":[],"published":{"date-parts":[[2015,1,20]]},"assertion":[{"value":"2015-01-20","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}