Poster Session

P52. Open label, prospective, moisturizing and anti-itching efficacy study of a moisturizing vulvar gel containing borage oil, bisabolol and protective polymers.

Aurora Garre (ES), Sonia Aladren (ES), Corinne Granger (ES)

[Garre] ISDIN S.A., [Aladren] ISDIN S.A., [Granger ] ISDIN S.A.

Context: The mucocutaneous vulvar tissue is more susceptible than exposed skin due to the differences in structure, hydration, occlusion and susceptibility to friction. In addition, any decrease in estrogen levels could cause tissue atrophy and dryness, which are often accompanied by pruritus, and increases susceptibility to mechanical injury and chemical irritation. Objective: To evaluate the efficacy and tolerability of a moisturizing vulvar gel containing borage oil, bisabolol and protective polymers (MVG). Methods: Open label, prospective study. Patients: Thirty-one women between 40 and 70 years of age with xerosis and pruritus in the vulvar area. Interventions: Women were requested to apply the product twice daily for 4 weeks (28 days). A gynecological evaluation was performed before and after treatment. Main Outcome measures: Vulvar itching intensity was evaluated at day (D) 0, 1, 3 and 7 with a pruritus visual analogue scale (PVAS) (from 0=low intensity to 10=high intensity). In addition, the efficacy and cosmetic qualities of the product were evaluated by subjects with a questionnaire at D28. Tolerance was evaluated at D28 by a gynecologist through a visual examination of the treated area and the analysis of the vulvar reactions reported by subjects in a diary card during the entire study. Results: A statistically significant (p< 0.05) decrease in vulvar itching intensity was reported at D1, D3 and D7 versus D0. In addition, a statistically significant percentage of patients reported being satisfied with the product for: relief of discomfort related to vaginal dryness and a general comfortable feeling (97%); moisturizing the vulvar area and helping to relieve vulvar itching (94%); and relief of feeling of irritation (90%). Tolerance was considered good by the gynecologist. Conclusion: The Vulvar Moisturizing Gel containing borage oil, bisabolol and protective polymers has been shown to relieve vulvar pruritus intensity from the first day of use, and to improve dryness and irritation after 28 days of use in women with itching and dryness in the vulvar area.