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

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02541721
• Other study ID #: LF-01-01
• Status: Terminated
• Phase: N/A
• First received: September 2, 2015
• Last updated: February 20, 2018
• Start date: September 2015
• Est. completion date: January 2018

Study information

• Verified date: February 2018
• Source: Health Products Research and Development Lda.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Disease of Skin
• Skin Diseases

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Portugal	Centro Hospitalar Cova da Beira EPE	Covilhã	Castelo Branco
Portugal	Hospital Garcia da Orta, EPE	Lisboa	Almada
Portugal	Unidade Local de Saúde de Matosinhos	Matosinhos	Senhora Da Hora
Portugal	Centro Hospitalar de S. João EPE	Porto
Portugal	Apomédica - Serviços Médicos Ltd	Póvoa de Varzim	Porto
Portugal	Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E	Vila Nova de Gaia

Sponsors (2)

Lead Sponsor	Collaborator
Health Products Research and Development Lda.	Blueclinical, Ltd.

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	14 days during run-in period and 14 days during treatment period
Secondary	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).	During 4 weeks
Secondary	Clinical Global Impression of Change (CGI-C)		At Visit 3 (28 days after the end of baseline)
Secondary	Patient Global Impression of Change (PGI-C)		At Visit 3 (28 days after the end of baseline)
Secondary	Subjects' opinion on the acceptability of the medical device	Subjects' opinion on the acceptability of the medical device (cosmetic acceptability and easiness of use)	At Visit 3 (28 days after the end of baseline)
Secondary	Need of rescue medication		Up to 6 weeks
Secondary	Adverse events		Up to 6 weeks