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

Not Applicable

Terminated

• Conditions: Chronic Disease of Skin
• Interventions: Device: LabiaStick#01

• Registration Number: NCT02541721
• Lead Sponsor: Health Products Research and Development Lda.

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.

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-09-02
• Study First Submitted QC: 2015-09-02
• Study First Posted: 2015-09-04
• Primary Completion: 2018-01
• Study Completion: 2018-01
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-20
• Last Update Posted: 2018-02-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 3

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).
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)
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)
Adverse events	Up to 6 weeks
Need of rescue medication	Up to 6 weeks

Trial Locations

Locations (6)

Centro Hospitalar de S. João EPE; 🇵🇹 Porto, Portugal

Unidade Local de Saúde de Matosinhos; 🇵🇹 Matosinhos, Senhora Da Hora, Portugal

Hospital Garcia da Orta, EPE; 🇵🇹 Lisboa, Almada, Portugal

Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E; 🇵🇹 Vila Nova de Gaia, Portugal

Centro Hospitalar Cova da Beira EPE; 🇵🇹 Covilhã, Castelo Branco, Portugal

Apomédica - Serviços Médicos Ltd; 🇵🇹 Póvoa de Varzim, Porto, Portugal