{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,2]],"date-time":"2026-05-02T13:07:59Z","timestamp":1777727279448,"version":"3.51.4"},"reference-count":30,"publisher":"SAGE Publications","issue":"9","license":[{"start":{"date-parts":[[2018,6,7]],"date-time":"2018-06-07T00:00:00Z","timestamp":1528329600000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["J Int Med Res"],"published-print":{"date-parts":[[2018,9]]},"abstract":"<jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To evaluate the efficacy, tolerability and acceptability of Zelesse\u00ae, an intimate hygiene wash solution, in the relief of the symptoms and signs of non-specific vulvovaginitis in paediatric patients.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>The NINESSE Study was a prospective, observational, multicentre study involving females aged 2\u20138 years who attended paediatric offices with symptoms suggestive of non-specific vulvovaginitis. They were administered Zelesse\u00ae as a single treatment for 15\u2009\u00b1\u20095 days. Pruritus, burning, dysuria, erythema, leucorrhoea and oedema were evaluated before and after treatment.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>A total of 71 paediatric patients were enrolled in the study (mean\u2009\u00b1\u2009SD age, 4.5\u2009\u00b1\u20091.9 years). The most significant effects were observed for pruritus and burning, where 98.4% (62 of 63) and 96.9% (63 of 65) of the patients improved after treatment, respectively. Zelesse\u00ae demonstrated a beneficial effect on dysuria, erythema, leucorrhoea and oedema. The effects on the symptoms and signs were observed within the first week of treatment; although 44.9% (31 of 69) of patients experienced improvements after 2\u20133 days. Zelesse\u00ae was well accepted and tolerated by most patients. No serious adverse events were reported.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Zelesse\u00ae was very effective for the relief of the symptoms and signs of non-specific vulvovaginitis, in particular pruritus, burning and erythema, in females aged 2\u20138 years.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/0300060518775566","type":"journal-article","created":{"date-parts":[[2018,6,7]],"date-time":"2018-06-07T07:35:29Z","timestamp":1528356929000},"page":"3583-3595","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":1,"title":["Efficacy, acceptability and tolerability of Zelesse\u00ae for the treatment of non-specific vulvovaginitis in paediatric patients: The NINESSE Study"],"prefix":"10.1177","volume":"46","author":[{"given":"F\u00e1tima","family":"Garc\u00eda","sequence":"first","affiliation":[{"name":"Private Paediatrics Office, Hospital Virgen del Mar, Madrid, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Carmen-Amparo","family":"Rodr\u00edguez","sequence":"additional","affiliation":[{"name":"Department of Primary Care Paediatrics, Centro de Salud Casa del Mar, A Coru\u00f1a, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mar\u00eda-Lourdes","family":"Palomo","sequence":"additional","affiliation":[{"name":"Private Paediatrics Office, Centro M\u00e9dico Oporto, Madrid, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pere","family":"Catal\u00e0","sequence":"additional","affiliation":[{"name":"Private Paediatrics Office, Centro M\u00e9dico Medinfant, Barcelona, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Santiago","family":"Fern\u00e1ndez","sequence":"additional","affiliation":[{"name":"Private Paediatrics Office, Cl\u00ednica Pedi\u00e1trica Fern\u00e1ndez Cebri\u00e1n, Ourense, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ibone","family":"Huerta","sequence":"additional","affiliation":[{"name":"Medical Department, ITF Research Pharma S.L.U., Madrid, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Syra","family":"Velasco","sequence":"additional","affiliation":[{"name":"Medical Department, ITF Research Pharma S.L.U., Madrid, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Concepci\u00f3n","family":"Nieto","sequence":"additional","affiliation":[{"name":"Medical Department, ITF Research Pharma S.L.U., Madrid, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"name":"as the writing group of the NINESSE study","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2018,6,7]]},"reference":[{"key":"bibr1-0300060518775566","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.330.7484.186"},{"key":"bibr2-0300060518775566","doi-asserted-by":"publisher","DOI":"10.1136\/adc.67.4.509"},{"key":"bibr3-0300060518775566","doi-asserted-by":"publisher","DOI":"10.1136\/adc.88.4.324"},{"key":"bibr4-0300060518775566","doi-asserted-by":"publisher","DOI":"10.1007\/s00431-003-1373-x"},{"key":"bibr5-0300060518775566","doi-asserted-by":"crossref","first-page":"758","DOI":"10.1542\/peds.65.4.758","volume":"65","author":"Emans SJ","year":"1980","journal-title":"Pediatrics"},{"key":"bibr6-0300060518775566","doi-asserted-by":"publisher","DOI":"10.1542\/pir.14-4-141"},{"key":"bibr7-0300060518775566","doi-asserted-by":"publisher","DOI":"10.1136\/adc.2009.181883"},{"key":"bibr8-0300060518775566","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpag.2015.07.002"},{"key":"bibr9-0300060518775566","first-page":"763","volume":"43","author":"Fivozinsky KB","year":"1998","journal-title":"J Reprod Med"},{"key":"bibr10-0300060518775566","unstructured":"Laufer MR, Emans SJ. Overview of vulvovaginal complaints in the prepubertal child. UpToDate\u00ae. Available at: http:\/\/www.uptodate.com\/contents\/overview-of-vulvovaginal-complaints-in-the-prepubertal-child [accessed 08 July 2017]."},{"key":"bibr11-0300060518775566","unstructured":"Zelesse. Brochure of product. Italfarmaco. Available at: www.zelesse.com\/documents\/708881\/14232616\/prospecto_zelesse_230514_web.pdf [accessed 08 July 2017]."},{"key":"bibr12-0300060518775566","unstructured":"Delgado Mar\u00edn JL, Oliva S\u00e1nchez R, San Mart\u00edn Moral R, et\u00a0al. Eficacia de una nueva soluci\u00f3n para el lavado y la higiene \u00edntima sobre los s\u00edntomas y signos de la vulvovaginitis aguda. Poster presented at: XIX SEMERGEN Congress; 6\u20137 June; 2014; Valencia (Spain)."},{"key":"bibr13-0300060518775566","unstructured":"Arg\u00fcelles Mart\u00ednez E, Delgado Mar\u00edn JL, Blanco Carnero JE, et\u00a0al. Utilidad de Zelesse\u00ae una nueva soluci\u00f3n de higiene intima como coadyuvante en el tratamiento de las vulvovaginitis agudas de causa infecciosa. Abstract XIX SEMERGEN Congress; 6\u20137; 2014; Valencia (Spain)."},{"key":"bibr14-0300060518775566","unstructured":"San Martin R, Delgado JL, Oliva R, et\u00a0al. Zelesse a new intimate hygiene wash solution for the relief of symptoms and signs of acute vulvovaginitis. Poster presented at: The 20th World Congress on Controversies in Obstetrics, Gynecology & Infertility (COGI); 4\u20137 December; 2014; Paris (France)."},{"key":"bibr15-0300060518775566","unstructured":"Delgado JL, Oliva R, Blanco JE, et\u00a0al. Zelesse\u00ae, a new intimate hygiene wash solution for the relief of symptoms and signs of acute nonspecific vulvovaginitis. Poster presented at: The International Congress of the French Society of Gynecology; 2014 ."},{"key":"bibr16-0300060518775566","unstructured":"US Dept. Health and Human Services (2003). Guidance for Industry: Estrogen and estrogen\/progestin drug products to treat vasomotor symptoms and vulvar and vaginal atrophy symptoms - Recommendations for Clinical Evaluation. Draft Guidance. Washington: U.S. Department of Health and Human Services. Available at: https:\/\/www.fda.gov\/downloads\/drugs\/guidancecomplianceregulatoryinformation\/guidances\/ucm071643.pdf. [accessed 06 April 2018]."},{"key":"bibr17-0300060518775566","doi-asserted-by":"publisher","DOI":"10.1097\/gme.0b013e3182518e9a"},{"key":"bibr18-0300060518775566","first-page":"149","volume":"3","author":"Aruda MM.","year":"1992","journal-title":"Nurse Pract Forum"},{"key":"bibr19-0300060518775566","unstructured":"Berlier P. [Cuidados en la higiene vulvo perineal a prop\u00f3sito del seguimiento de 42 casos del uso de saforelle en ni\u00f1as]. Article in Spanish. Study presented at: III Rencontres Alfred Fournier Meeting; June; 1990; Cannes (France). Available at: http:\/\/pedia-gess.com\/archivos1pdf\/Saforelle%20solucion%20-%20higiene%20vulvo%20perineal.pdf. [accessed 08 July 2017]."},{"key":"bibr20-0300060518775566","doi-asserted-by":"publisher","DOI":"10.1155\/2014\/541867"},{"key":"bibr21-0300060518775566","unstructured":"Masero Casasola AR, Guill\u00e1n Maquieira C, San Frutos Llorente L, et\u00a0al. Alivio del prurito en mujeres con vulvovaginitis aguda mediante el uso de una crema \u00edntima a base de Camomila, Bardana y Aloe Vera. Estudio Zelina. Poster \u2013 SEGO Congress, 2017, Oviedo; Spain."},{"key":"bibr22-0300060518775566","doi-asserted-by":"publisher","DOI":"10.18773\/austprescr.2005.071"},{"key":"bibr23-0300060518775566","doi-asserted-by":"publisher","DOI":"10.3390\/ijms17030425"},{"key":"bibr24-0300060518775566","unstructured":"Healthychildren.org. Vaginal symptoms. 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