Chronic Disease of Skin Clinical Trial
Official title:
An Open-label Study to Investigate the Effectiveness in Clinical Symptomatic Control and Tolerability of Medical Device LabiaStick#01 in Subjects With Symptomatic Non-hypertrophic Chronic Vulvar Dermatoses
The current study aims to investigate the effectiveness in clinical symptomatic control and tolerability of LabiaStick#01 in women with symptomatic non-hypertrophic chronic vulvar dermatoses.
Vulvar dermatoses are skin disorders that affect the vulva, causing pruritus, irritation and
pain. Although the prevalence of these disorders is unknown, it is well accepted that the
vulvar symptoms are a common problem for women.
LabiaStick#01 has emollient agents whose main function is to increase the skin hydration,
provide physical protection and decrease the symptoms and possibility of recurrence of vulvar
dermatoses.
The medical device should be applied once daily, in the evening, after intimal hygiene care.
The primary objective of this study is to evaluate the effectiveness of LabiaStick#01 on the
relief of pruritus caused by symptomatic non-hypertrophic chronic vulvar dermatoses.
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