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Trial record 1 of 1 for:    LF-01-01
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Effectiveness and Tolerability of LabiaStick#01 in Subjects With Symptomatic Non-hypertrophic Chronic Vulvar Dermatoses

This study is currently recruiting participants.
Verified March 2017 by Health Products Research and Development Lda.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02541721
First Posted: September 4, 2015
Last Update Posted: March 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Blueclinical, Ltd.
Information provided by (Responsible Party):
Health Products Research and Development Lda.
  Purpose
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.

Condition Intervention
Chronic Disease of Skin Device: LabiaStick#01

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Health Products Research and Development Lda.:

Primary Outcome Measures:
  • Reduction on subject's vulvar pruritus score [ Time Frame: 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:
  • Reduction on subject's vulvar burning sensation score [ Time Frame: 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) [ Time Frame: At Visit 3 (28 days after the end of baseline) ]
  • 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) ]
    Subjects' opinion on the acceptability of the medical device (cosmetic acceptability and easiness of use)

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

Estimated Enrollment: 75
Study Start Date: September 2015
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LabiaStick#01
Each participant will have an at least 2-week baseline period followed by a 4-week treatment period with LabiaStick#01.
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.


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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02541721


Contacts
Contact: José Martinez de Oliveira, MD, PhD +351 917 577 343 jmo@fcsaude.ubi.pt

Locations
Portugal
Hospital Garcia da Orta, EPE Not yet recruiting
Lisboa, Almada, Portugal, 2805-267
Contact: Elvira Bártolo, MD    212727137      
Centro Hospitalar Cova da Beira EPE Recruiting
Covilhã, Castelo Branco, Portugal, 6200-251
Contact: José Martinez de Oliveira, MD, PhD    +351 - 275 330 000      
Apomédica - Serviços Médicos Ltd Recruiting
Póvoa de Varzim, Porto, Portugal, 4490-405
Contact: José Martinez de Oliveira, MD, PhD    +351 - 252 688 183      
Unidade Local de Saúde de Matosinhos Not yet recruiting
Matosinhos, Senhora da Hora, Portugal, 4464-513
Contact: Marta Rodrigues, MD    911962334 ext 6817      
Centro Hospitalar de S. João EPE Recruiting
Porto, Portugal, 4200-319
Contact: Pedro Vieira Baptista, MD    +351 - 225 512 100      
Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E Not yet recruiting
Vila Nova de Gaia, Portugal, 4400-129
Contact: Maria Elisa Paredes, MD    962360149      
Sponsors and Collaborators
Health Products Research and Development Lda.
Blueclinical, Ltd.
Investigators
Principal Investigator: José Martinez de Oliveira, MD, PhD HPRD
  More Information

Responsible Party: Health Products Research and Development Lda.
ClinicalTrials.gov Identifier: NCT02541721     History of Changes
Other Study ID Numbers: LF-01-01
First Submitted: September 2, 2015
First Posted: September 4, 2015
Last Update Posted: March 3, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Chronic Disease
Skin Diseases
Disease Attributes
Pathologic Processes