Chronic Disease of Skin
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICELabiaStick#01
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.
Sponsors
Blueclinical, Ltd.
Health Products Research and Development Lda.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Able and willing to give written informed consent. * Woman, with 18 or more years. * Diagnosed with symptomatic non-hypertrophic chronic vulvar dermatoses. * A pruritus score of at least 20 on a 100-mm VAS-PR. * Willing and able to comply with the study requirements. * Participant of childbearing potential agrees to remain abstinent or to use an acceptable contraceptive measure for the entire duration of the study. * Participant not of childbearing potential (e.g., is not sexually active, whose current partner is not of reproductive potential).
Exclusion criteria
* Received systemic immunosuppressant therapy (e.g. systemic corticosteroids) within 4 weeks prior to admission. * Treated with daily topical therapy (e.g. topical corticosteroids, pimecrolimus, and tacrolimus) at the target vulvar area within 2 weeks prior to admission, which in the opinion of the investigator might compromise study results. * Immunocompromised (e.g., lymphoma, AIDS, Wiskott-Aldrich Syndrome) or have an uncontrolled malignant disease. * Suffers from systemic or generalized infections (bacterial, viral or fungal). * Diagnosis of psoriasis, candidiasis, vulvar intraepithelial neoplasia or carcinoma of the vulva. * Pregnancy or breastfeeding. * Documented and consistent history of hypersensitivity reactions to similar topical products. * Any condition that in the opinion of the investigator might prevent the subject from completing the study or interfere with the interpretation of the study results.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction on subject's vulvar pruritus score | 14 days during run-in period and 14 days during treatment period | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Global Impression of Change (CGI-C) | At Visit 3 (28 days after the end of baseline) | — |
| Patient Global Impression of Change (PGI-C) | At Visit 3 (28 days after the end of baseline) | — |
| Reduction on subject's vulvar burning sensation score | During 4 weeks | Reduction on subject's vulvar burning sensation score assessed on a 100-mm Visual Analogue Scale (Burning VAS). |
| Need of rescue medication | Up to 6 weeks | — |
| Adverse events | Up to 6 weeks | — |
| Subjects' opinion on the acceptability of the medical device | At Visit 3 (28 days after the end of baseline) | Subjects' opinion on the acceptability of the medical device (cosmetic acceptability and easiness of use) |
Countries
Portugal
Outcome results
None listed