Gynäkologie und Geburtshilfe
Offener Zugang

Abstrakt

Clinical Evidence on a New Thymol and Zinc-Based Cleanser for Feminine Hygiene in a Double-Blind Controlled Randomized Study

Cappelli V, Benvenuti C, Gasparri F, Andrea A, De Leo

Objective: In women hypersensitive to aggressive detergents or easily developing genital dryness, the daily feminine hygiene should require caution in adopting an adequate product to avoid the onset or the impairment of an inflammatory condition, still maintaining high protection against infection. A new intimate cleanser, called Saugella Acti3 (SA3), containing antimicrobial ingredients (thymol and Zinc) with mild non-aggressive natural surfactants (derived from coconut and the amino acids of wheat) and mucoadhesive agents (xanthan gum and carrageenan) was formulated. Zinc potentiates antimicrobial, anti-inflammatory and antioxidant action of thymol, and the mucoadhesive system increases the permanence in situ of the active ingredients, so prolonging their effect. Natural surfactants stimulate an epidermal renewal of keratinocytes, restructuring the damaged skin and restoring the cutaneous lipid layer removed during washing. The study evaluated the clinical effect of SA3 in a controlled randomized study versus a standard cleanser in fertile age women more exposed to infection risk condition and hypersensitive to aggressive detergents.

Material and Methods: Women of childbearing potential needing effective intimate hygiene in specific life periods (menstrual cycle, pregnancy or post-partum and infection risk conditions) were enrolled in a double-blind, controlled, parallel-group, randomized study. The women were assigned to the treatment with SA3 (Saugella Acti3, Mylan) a standard detergent for feminine care, twice daily for 4 weeks. Clinical evaluations were performed at baseline, 2 and 4 weeks.

Results: Forty-eight women, 24 per treatment, mean age 31.9 years, were treated. Symptoms severity was significantly reduced versus baseline with SA3, compared to what observed with I: for itching 42.0% on SA3 vs +20.0% on I), burning (-35.5% vs +85.2%), dyspareunia (-63.6% vs +42.9%).

At the end of the treatment, SA3 was superior to I: women felt significantly better vs baseline 70.8% vs 8.3%, the overall condition improved in 66.7% vs 12.5%, and the availability to continue the treatment was confirmed by 83.3% vs 41.7%.

Conclusion: The combination of microbiologically active ingredients, whose action is prolonged by mucoadhesive components even after cleansing, supported by natural non-aggressive surfactants, allowed a better clinical result than a standard detergent in intimate hygiene in infection risk conditions.