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

NCT ID: NCT02541721

Last Updated: 2018-02-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2018-01-31

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.

Conditions

Chronic Disease of Skin

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LabiaStick#01

Each participant will have an at least 2-week baseline period followed by a 4-week treatment period with LabiaStick#01.

Group Type: EXPERIMENTAL

LabiaStick#01

Intervention Type: DEVICE

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.

Interventions

LabiaStick#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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Blueclinical, Ltd.

OTHER

Sponsor Role: collaborator

Health Products Research and Development Lda.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

José Martinez de Oliveira, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

HPRD

Locations

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

Centro Hospitalar de S. João EPE

Porto, , Portugal

Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E

Vila Nova de Gaia, , Portugal

Countries

Portugal

Other Identifiers

LF-01-01

Identifier Type: -

Identifier Source: org_study_id