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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02541721
• Date of registration: 02/09/2015
• Prospective Registration: No
• Primary sponsor: Health Products Research and Development Lda.
• Public title: Effectiveness and Tolerability of LabiaStick#01 in Subjects With Symptomatic Non-hypertrophic Chronic Vulvar Dermatoses
• Scientific 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
• Date of first enrolment: September 2015
• Target sample size: 3
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02541721
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Portugal

Contacts

• Name: José Martinez de Oliveira, MD, PhD
• Affiliation: HPRD

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Chronic Disease of Skin

Intervention(s)

Device: LabiaStick#01

Primary Outcome(s)

Reduction on subject's vulvar pruritus score [Time Frame: 14 days during run-in period and 14 days during treatment period]

Secondary Outcome(s)

Reduction on subject's vulvar burning sensation score [Time Frame: During 4 weeks]

Clinical Global Impression of Change (CGI-C) [Time Frame: At Visit 3 (28 days after the end of baseline)]

Need of rescue medication [Time Frame: Up to 6 weeks]

Patient Global Impression of Change (PGI-C) [Time Frame: At Visit 3 (28 days after the end of baseline)]

Subjects' opinion on the acceptability of the medical device [Time Frame: At Visit 3 (28 days after the end of baseline)]

Adverse events [Time Frame: Up to 6 weeks]

Secondary ID(s)

LF-01-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Blueclinical, Ltd.