Effectiveness and Tolerability of LabiaStick#01 in Subjects With Symptomatic Non-hypertrophic Chronic Vulvar Dermatoses

Health Products Research and Development Lda.

Status

Terminated

Conditions

Chronic Disease of Skin

Treatments

Device: LabiaStick#01

Study type

Interventional

Funder types

Other

Identifiers

NCT02541721

LF-01-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

3 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.