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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
This medical device 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 a gentle washing (plain water with no cleansing products), on the affected non-hairy vulvar area.
Hospital Garcia da Orta, EPE
Lisbon, Almada, Portugal
Centro Hospitalar Cova da Beira EPE
Covilha, Castelo Branco District, Portugal
Apomédica - Serviços Médicos Ltd
Póvoa de Varzim, Porto District, Portugal
Unidade Local de Saúde de Matosinhos
Matosinhos Municipality, Senhora Da Hora, Portugal
Reduction on subject's vulvar pruritus score
Reduction on subject's vulvar pruritus score assessed on a 100-mm Visual Analogue Scale for Pruritus Relief (VAS-PR) following once-daily application of LabiaStick#01, for 4 weeks.
Time frame: 14 days during run-in period and 14 days during treatment period
Reduction on subject's vulvar burning sensation score
Reduction on subject's vulvar burning sensation score assessed on a 100-mm Visual Analogue Scale (Burning VAS).
Time frame: During 4 weeks
Clinical Global Impression of Change (CGI-C)
Time frame: At Visit 3 (28 days after the end of baseline)
Patient Global Impression of Change (PGI-C)
Time frame: At Visit 3 (28 days after the end of baseline)
Subjects' opinion on the acceptability of the medical device
Subjects' opinion on the acceptability of the medical device (cosmetic acceptability and easiness of use)
Time frame: At Visit 3 (28 days after the end of baseline)
Need of rescue medication
Time frame: Up to 6 weeks
Adverse events
Time frame: Up to 6 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Centro Hospitalar de S. João EPE
Porto, Portugal
Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E
Vila Nova de Gaia, Portugal