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

NCT02541721 | Terminated

• 1 other identifier: LF-01-01
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 6

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.

Conditions

Chronic Disease of Skin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Reduction on subject's vulvar burning sensation score

  During 4 weeks

• 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)

• Need of rescue medication

  Up to 6 weeks

Study Arms (1)

LabiaStick#01

EXPERIMENTAL

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

Device: LabiaStick#01

Interventions

LabiaStick#01 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.

LabiaStick#01

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Health Products Research and Development Lda.: lead
• Blueclinical, Ltd.: collaborator

Study Sites (6)

Hospital Garcia da Orta, EPE

Lisbon, Almada, 2805-267, Portugal

Location

Centro Hospitalar Cova da Beira EPE

Covilha, Castelo Branco District, 6200-251, Portugal

Location

Apomédica - Serviços Médicos Ltd

Póvoa de Varzim, Porto District, 4490-405, Portugal

Location

Unidade Local de Saúde de Matosinhos

Matosinhos Municipality, Senhora Da Hora, 4464-513, Portugal

Location

Centro Hospitalar de S. João EPE

Porto, 4200-319, Portugal

Location

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

Vila Nova de Gaia, 4400-129, Portugal

Location

Study Officials

• José Martinez de Oliveira, MD, PhD

  HPRD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2015
• First Posted: September 4, 2015
• Study Start: September 1, 2015
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: February 22, 2018

Record last verified: 2018-02

Locations

PT (6)