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

Abstract

ObjectiveTo 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.MethodsThe 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.ResultsA 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.ConclusionsZelesse® 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.

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

“…In line with previous studies conducted with Zelesse, 12,13 in our study, the score and prevalence of signs and symptoms were significantly decreased after treatment compared with baseline in women with noninfectious VV who had Zelesse only and in women with infectious VV who had adjuvant treatment to antimicrobial therapy.…”

“…In line with previous studies conducted with Zelesse, 12 , 13 in our study, the score and prevalence of signs and symptoms were significantly decreased after treatment compared with baseline in women with non-infectious VV who had Zelesse only and in women with infectious VV who had adjuvant treatment to antimicrobial therapy. The scarcity of clinical trials, case mix of extract combinations, and heterogeneity of assessment of effectiveness of natural products for treating VV preclude indirect comparison of effectiveness based on the literature.…”

“…11 , 12 Furthermore, these results were confirmed in female children aged 2 to 8 years with non-infectious VV. 13 In this observational study, we aimed to assess the efficacy, tolerability, and acceptability of Zelesse cream in adult women with signs and symptoms of VV when using this cream as either monotherapy or adjuvant to antibiotic/antifungal treatment.…”