Efficacy, acceptability and tolerability of Zelesse® for the treatment of non-specific vulvovaginitis in paediatric patients: The NINESSE Study. Issue 9 (September 2018)

• Record Type: Journal Article
• Authors: García, Fátima; Rodríguez, Carmen-Amparo; Palomo, María-Lourdes; Català, Pere; Fernández, Santiago; Huerta, Ibone; Velasco, Syra; Nieto, Concepción
• Is Part Of: Journal of international medical research. Volume 46:Issue 9(2018)
• Page Start: 3583
• Page End: 3595
• Publication Date: 2018-09
• Subjects: Acceptability -- efficacy -- non-specific vulvovaginitis -- paediatric -- tolerability -- Zelesse®; Medicine -- Periodicals; Pharmacology -- Periodicals; 610.5
• DOI: 10.1177/0300060518775566
• Languages: English
• ISSNs: 0300-0605

Abstract

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.