COGI Paris 2014 - Abstract Submission

ZELESSE A NEW INTIMATE HYGIENE WASH SOLUTION FOR THE RELIEF OF SYMPTOMS
AND SIGNS OF ACUTE VULVOVAGINITIS

Autores: Raquel San Martin1; Juan Luis Delgado2; Raquel Oliva2; Jose Eliseo Blanco2; Inmaculada
Muñoz1; Ibone Huerta3; Marcos Cuerva4; Jesús Lazaro5

(1) Department of Obstetrics & Gynecology, Specialist Medical Clinic, Madrid, (2) Department of
Obstetrics & Gynecology, University Hospital Virgen de Arrixaca, Murcia, (3) Medical Department,
Italfarmaco, (4) Department of Obstetrics & Gynecology, Hospital Quirón San José, (5) Department
of Obstetrics & Gynecology, University Hospital Ramón y Cajal, Madrid, Spain.

Problem Statement: Vulvovaginitis, an inflammatory disease of the vulvar and vaginal area, is a
highly prevalent condition -with diverse symptoms and signs- affecting women of all ages. The
most annoying and relevant symptom, the women’s principal complaint, is itching. In many cases
the genital area is shown red and edematous, and increased vaginal discharge may occur. Zelesse
an intimate hygiene wash solution, based on Chamomile, Burdock and Aloe Vera, with soothing,
antipruritic and antiseptic properties may be beneficial for the symptomatic relief of
vulvovaginitis. The aim of this study was to evaluate the effect and tolerability of Zelesse indicated
alone or in combination with specific pharmacological treatment in patients with symptoms
suggestive of vulvovaginitis.

Methods: This is a prospective observational multicenter clinical trial. 137women with symptoms
of acute vulvovaginitis (mean age 38.6±11.1years) were included, 50women (SF group) with
symptoms of nonspecific vulvovaginitis (mean age 42.4±11.9years) received Zelesse once or twice
a day during 12 days. 87women (CF group) with vulvovaginal infection (mean age 36.5±10.1years)
were treated with specific pharmacological therapy and also received Zelesse twice a day. At
baseline and at the end of treatment, symptoms and signs were evaluated with a validated
numeric scale 0=absent, 1=mild, 2=moderate and 3=severe. A composite score of symptoms, the
Global Symptom Score (GSS), was obtained to assess the effect of treatment on all individual
symptoms taken as a whole.

Results: At baseline, 93% of women reported pruritus, erythema 80%, 59%edema, and 75%
leucorrhoea. In the SF group, 93% of women who afflicted pruritus at baseline experienced
improvement after treatment, reducing its intensity from 1.9 to 0.5 (p<0.0001,t-student). Zelesse
also showed beneficial effect on the rest of the evaluated signs of vulvovaginitis. Zelesse improved
erythema, edema and vaginal discharge in 68%, 87% and 77% of women who had these signs at
baseline, respectively. Also, after treatment, 94%, 96% and 84% of women either did not show or
only presented mild erythema, edema or leucorrhea, respectively. In the CF group 89.6% of
patients with moderate to severe pruritus decreased its intensity to absent or mild, being reduced
from 2.35 to 0.5 (p<0.0001,t-student). On the rest of the evaluated signs, the effects of the
combination therapy were also beneficial, 95.2% of patients with moderate/severe erythema
decreased its intensity to absent/mild, as well as 97.3% of those with edema and 92.0% of women
with leucorrhoea. Interestingly after treatment, both groups showed similar significant
improvement of the GSS with respect to baseline: in the SF group GSS decreased from 4.8 to 1.5
(p<0.0001,t-student) and in the CF group the GSS decreased from 7.41 to 1.42 (p<0.0001,t-
student). Finally, 84.5% of women felt that the tolerability of the product was very good or
excellent, highlighting its soothing and refreshing properties.

Conclusion: Zelesse is effective for relieving symptoms and signs of acute nonspecific
vulvovaginitis as well as good adjuvant therapy in the management of vulvovaginal infection. The
similar final GSS after treatment also suggests the beneficial effects of Zelesse on signs and
symptoms of vulvovaginitis. The significant effect on pruritus, the most disturbing symptom, is
considered clinically relevant since pruritus is a very distressing and persistent symptom which
usually does not diminish without treatment.