Efficacy, acceptability and tolerability of Zelesse® for the treatment of non-specific vulvovaginitis in paediatric patients: The NINESSE Study

Objective To evaluate the efficacy, tolerability and acceptability of Zelesse®, an intimate hygiene wash solution, in the relief of the symptoms and signs of non-specific vulvovaginitis in paediatric patients. Methods The NINESSE Study was a prospective, observational, multicentre study involving fe...

Full description

Bibliographic Details
Main Authors: Fátima García, Carmen-Amparo Rodríguez, María-Lourdes Palomo, Pere Català, Santiago Fernández, Ibone Huerta, Syra Velasco, Concepción Nieto
Format: Article
Language:English
Published: SAGE Publishing 2018-09-01
Series:Journal of International Medical Research
Online Access:https://doi.org/10.1177/0300060518775566
_version_ 1818723353852116992
author Fátima García
Carmen-Amparo Rodríguez
María-Lourdes Palomo
Pere Català
Santiago Fernández
Ibone Huerta
Syra Velasco
Concepción Nieto
author_facet Fátima García
Carmen-Amparo Rodríguez
María-Lourdes Palomo
Pere Català
Santiago Fernández
Ibone Huerta
Syra Velasco
Concepción Nieto
author_sort Fátima García
collection DOAJ
description Objective To evaluate the efficacy, tolerability and acceptability of Zelesse®, an intimate hygiene wash solution, in the relief of the symptoms and signs of non-specific vulvovaginitis in paediatric patients. Methods The NINESSE Study was a prospective, observational, multicentre study involving females aged 2–8 years who attended paediatric offices with symptoms suggestive of non-specific vulvovaginitis. They were administered Zelesse® as a single treatment for 15 ± 5 days. Pruritus, burning, dysuria, erythema, leucorrhoea and oedema were evaluated before and after treatment. Results A total of 71 paediatric patients were enrolled in the study (mean ± SD age, 4.5 ± 1.9 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® 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 2–3 days. Zelesse® was well accepted and tolerated by most patients. No serious adverse events were reported. Conclusions Zelesse® was very effective for the relief of the symptoms and signs of non-specific vulvovaginitis, in particular pruritus, burning and erythema, in females aged 2–8 years.
first_indexed 2024-12-17T21:09:11Z
format Article
id doaj.art-f74807bdccb24745a1b0701186a8ec1d
institution Directory Open Access Journal
issn 0300-0605
1473-2300
language English
last_indexed 2024-12-17T21:09:11Z
publishDate 2018-09-01
publisher SAGE Publishing
record_format Article
series Journal of International Medical Research
spelling doaj.art-f74807bdccb24745a1b0701186a8ec1d2022-12-21T21:32:30ZengSAGE PublishingJournal of International Medical Research0300-06051473-23002018-09-014610.1177/0300060518775566Efficacy, acceptability and tolerability of Zelesse® for the treatment of non-specific vulvovaginitis in paediatric patients: The NINESSE StudyFátima GarcíaCarmen-Amparo RodríguezMaría-Lourdes PalomoPere CatalàSantiago FernándezIbone HuertaSyra VelascoConcepción Nieto Objective To evaluate the efficacy, tolerability and acceptability of Zelesse®, an intimate hygiene wash solution, in the relief of the symptoms and signs of non-specific vulvovaginitis in paediatric patients. Methods The NINESSE Study was a prospective, observational, multicentre study involving females aged 2–8 years who attended paediatric offices with symptoms suggestive of non-specific vulvovaginitis. They were administered Zelesse® as a single treatment for 15 ± 5 days. Pruritus, burning, dysuria, erythema, leucorrhoea and oedema were evaluated before and after treatment. Results A total of 71 paediatric patients were enrolled in the study (mean ± SD age, 4.5 ± 1.9 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® 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 2–3 days. Zelesse® was well accepted and tolerated by most patients. No serious adverse events were reported. Conclusions Zelesse® was very effective for the relief of the symptoms and signs of non-specific vulvovaginitis, in particular pruritus, burning and erythema, in females aged 2–8 years.https://doi.org/10.1177/0300060518775566
spellingShingle Fátima García
Carmen-Amparo Rodríguez
María-Lourdes Palomo
Pere Català
Santiago Fernández
Ibone Huerta
Syra Velasco
Concepción Nieto
Efficacy, acceptability and tolerability of Zelesse® for the treatment of non-specific vulvovaginitis in paediatric patients: The NINESSE Study
Journal of International Medical Research
title Efficacy, acceptability and tolerability of Zelesse® for the treatment of non-specific vulvovaginitis in paediatric patients: The NINESSE Study
title_full Efficacy, acceptability and tolerability of Zelesse® for the treatment of non-specific vulvovaginitis in paediatric patients: The NINESSE Study
title_fullStr Efficacy, acceptability and tolerability of Zelesse® for the treatment of non-specific vulvovaginitis in paediatric patients: The NINESSE Study
title_full_unstemmed Efficacy, acceptability and tolerability of Zelesse® for the treatment of non-specific vulvovaginitis in paediatric patients: The NINESSE Study
title_short Efficacy, acceptability and tolerability of Zelesse® for the treatment of non-specific vulvovaginitis in paediatric patients: The NINESSE Study
title_sort efficacy acceptability and tolerability of zelesse r for the treatment of non specific vulvovaginitis in paediatric patients the ninesse study
url https://doi.org/10.1177/0300060518775566
work_keys_str_mv AT fatimagarcia efficacyacceptabilityandtolerabilityofzelesseforthetreatmentofnonspecificvulvovaginitisinpaediatricpatientstheninessestudy
AT carmenamparorodriguez efficacyacceptabilityandtolerabilityofzelesseforthetreatmentofnonspecificvulvovaginitisinpaediatricpatientstheninessestudy
AT marialourdespalomo efficacyacceptabilityandtolerabilityofzelesseforthetreatmentofnonspecificvulvovaginitisinpaediatricpatientstheninessestudy
AT perecatala efficacyacceptabilityandtolerabilityofzelesseforthetreatmentofnonspecificvulvovaginitisinpaediatricpatientstheninessestudy
AT santiagofernandez efficacyacceptabilityandtolerabilityofzelesseforthetreatmentofnonspecificvulvovaginitisinpaediatricpatientstheninessestudy
AT ibonehuerta efficacyacceptabilityandtolerabilityofzelesseforthetreatmentofnonspecificvulvovaginitisinpaediatricpatientstheninessestudy
AT syravelasco efficacyacceptabilityandtolerabilityofzelesseforthetreatmentofnonspecificvulvovaginitisinpaediatricpatientstheninessestudy
AT concepcionnieto efficacyacceptabilityandtolerabilityofzelesseforthetreatmentofnonspecificvulvovaginitisinpaediatricpatientstheninessestudy
AT efficacyacceptabilityandtolerabilityofzelesseforthetreatmentofnonspecificvulvovaginitisinpaediatricpatientstheninessestudy