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Real-world effectiveness and tolerability of Zelesse cream® for treating vulvovaginitis in adult women: an observational, prospective study

OBJECTIVE: To assess the efficacy, acceptability, and tolerability of a vaginal cream based on plant extracts for treating signs and symptoms of vulvovaginitis (VV) (Zelesse cream®), either as monotherapy (non-infectious VV) or adjuvant to antimicrobial therapy (infectious VV). METHODS: This prospec...

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Autores principales: Masero, Ana Rosa, Frutos, Luís Manuel San, Vizcaíno, Ernesto, Palma, María, Velasco-Ortega, Syra, Nieto, Concepción
Formato: Online Artículo Texto
Lenguaje:English
Publicado: SAGE Publications 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8127803/
https://www.ncbi.nlm.nih.gov/pubmed/33983051
http://dx.doi.org/10.1177/03000605211013226
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author Masero, Ana Rosa
Frutos, Luís Manuel San
Vizcaíno, Ernesto
Palma, María
Velasco-Ortega, Syra
Nieto, Concepción
author_facet Masero, Ana Rosa
Frutos, Luís Manuel San
Vizcaíno, Ernesto
Palma, María
Velasco-Ortega, Syra
Nieto, Concepción
author_sort Masero, Ana Rosa
collection PubMed
description OBJECTIVE: To assess the efficacy, acceptability, and tolerability of a vaginal cream based on plant extracts for treating signs and symptoms of vulvovaginitis (VV) (Zelesse cream®), either as monotherapy (non-infectious VV) or adjuvant to antimicrobial therapy (infectious VV). METHODS: This prospective, observational, multicenter study included women who attended outpatient offices for VV. The severity of signs (vaginal discharge, erythema, and edema) and symptoms (pruritus, burning, and dysuria) was assessed before and after 15±5 days of daily treatment with Zelesse cream on a 4-point scale (18-point global score). RESULTS: The study included 58 women aged 43.0±13.2 years, including 42 who were treated with Zelesse cream only and 16 who used Zelesse cream as adjuvant to antimicrobial therapy. All participants showed significantly reduced scores and absolute prevalence of individual signs and symptoms in both groups. Similarly, the median signs/symptoms decreased by 4.0 and 8.0 points in women using Zelesse only and those using Zelesse plus antimicrobial therapy, respectively. This product was well tolerated and had high acceptability. CONCLUSIONS: Zelesse cream relieves signs and symptoms of VV, either as monotherapy in non-infectious VV or as adjuvant to antimicrobial therapy in infectious VV. Future randomized, placebo-controlled trials with larger sample sizes are warranted.
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spelling pubmed-81278032021-05-24 Real-world effectiveness and tolerability of Zelesse cream® for treating vulvovaginitis in adult women: an observational, prospective study Masero, Ana Rosa Frutos, Luís Manuel San Vizcaíno, Ernesto Palma, María Velasco-Ortega, Syra Nieto, Concepción J Int Med Res Prospective Clinical Research Report OBJECTIVE: To assess the efficacy, acceptability, and tolerability of a vaginal cream based on plant extracts for treating signs and symptoms of vulvovaginitis (VV) (Zelesse cream®), either as monotherapy (non-infectious VV) or adjuvant to antimicrobial therapy (infectious VV). METHODS: This prospective, observational, multicenter study included women who attended outpatient offices for VV. The severity of signs (vaginal discharge, erythema, and edema) and symptoms (pruritus, burning, and dysuria) was assessed before and after 15±5 days of daily treatment with Zelesse cream on a 4-point scale (18-point global score). RESULTS: The study included 58 women aged 43.0±13.2 years, including 42 who were treated with Zelesse cream only and 16 who used Zelesse cream as adjuvant to antimicrobial therapy. All participants showed significantly reduced scores and absolute prevalence of individual signs and symptoms in both groups. Similarly, the median signs/symptoms decreased by 4.0 and 8.0 points in women using Zelesse only and those using Zelesse plus antimicrobial therapy, respectively. This product was well tolerated and had high acceptability. CONCLUSIONS: Zelesse cream relieves signs and symptoms of VV, either as monotherapy in non-infectious VV or as adjuvant to antimicrobial therapy in infectious VV. Future randomized, placebo-controlled trials with larger sample sizes are warranted. SAGE Publications 2021-05-13 /pmc/articles/PMC8127803/ /pubmed/33983051 http://dx.doi.org/10.1177/03000605211013226 Text en © The Author(s) 2021 https://creativecommons.org/licenses/by-nc/4.0/Creative Commons Non Commercial CC BY-NC: This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages (https://us.sagepub.com/en-us/nam/open-access-at-sage).
spellingShingle Prospective Clinical Research Report
Masero, Ana Rosa
Frutos, Luís Manuel San
Vizcaíno, Ernesto
Palma, María
Velasco-Ortega, Syra
Nieto, Concepción
Real-world effectiveness and tolerability of Zelesse cream® for treating vulvovaginitis in adult women: an observational, prospective study
title Real-world effectiveness and tolerability of Zelesse cream® for treating vulvovaginitis in adult women: an observational, prospective study
title_full Real-world effectiveness and tolerability of Zelesse cream® for treating vulvovaginitis in adult women: an observational, prospective study
title_fullStr Real-world effectiveness and tolerability of Zelesse cream® for treating vulvovaginitis in adult women: an observational, prospective study
title_full_unstemmed Real-world effectiveness and tolerability of Zelesse cream® for treating vulvovaginitis in adult women: an observational, prospective study
title_short Real-world effectiveness and tolerability of Zelesse cream® for treating vulvovaginitis in adult women: an observational, prospective study
title_sort real-world effectiveness and tolerability of zelesse cream® for treating vulvovaginitis in adult women: an observational, prospective study
topic Prospective Clinical Research Report
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8127803/
https://www.ncbi.nlm.nih.gov/pubmed/33983051
http://dx.doi.org/10.1177/03000605211013226
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