Back to resultsEffectiveness and Tolerability of LabiaStick#01 in Subjects With Symptomatic Non-hypertrophic Chronic Vulvar Dermatoses
Primary Purpose
Chronic Disease of Skin
Status
Terminated
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
LabiaStick#01
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Disease of Skin
Eligibility 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.
Sites / Locations
- Hospital Garcia da Orta, EPE
- Centro Hospitalar Cova da Beira EPE
- Apomédica - Serviços Médicos Ltd
- Unidade Local de Saúde de Matosinhos
- Centro Hospitalar de S. João EPE
- Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
LabiaStick#01
Arm Description
Each participant will have an at least 2-week baseline period followed by a 4-week treatment period with LabiaStick#01.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
Clinical Global Impression of Change (CGI-C)
Patient Global Impression of Change (PGI-C)
Subjects' opinion on the acceptability of the medical device
Subjects' opinion on the acceptability of the medical device (cosmetic acceptability and easiness of use)
Need of rescue medication
Adverse events
Full Information
NCT ID
NCT02541721
First Posted
September 2, 2015
Last Updated
February 20, 2018
Sponsor
Health Products Research and Development Lda.
Collaborators
Blueclinical, Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02541721
Brief Title
Effectiveness and Tolerability of LabiaStick#01 in Subjects With Symptomatic Non-hypertrophic Chronic Vulvar Dermatoses
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Terminated
Why Stopped
New study design will be made
Study Start Date
September 2015 (undefined)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
January 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Health Products Research and Development Lda.
Collaborators
Blueclinical, Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Disease of Skin
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LabiaStick#01
Arm Type
Experimental
Arm Description
Each participant will have an at least 2-week baseline period followed by a 4-week treatment period with LabiaStick#01.
Intervention Type
Device
Intervention Name(s)
LabiaStick#01
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reduction on subject's vulvar pruritus score
Description
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.
Time Frame
14 days during run-in period and 14 days during treatment period
Secondary Outcome Measure Information:
Title
Reduction on subject's vulvar burning sensation score
Description
Reduction on subject's vulvar burning sensation score assessed on a 100-mm Visual Analogue Scale (Burning VAS).
Time Frame
During 4 weeks
Title
Clinical Global Impression of Change (CGI-C)
Time Frame
At Visit 3 (28 days after the end of baseline)
Title
Patient Global Impression of Change (PGI-C)
Time Frame
At Visit 3 (28 days after the end of baseline)
Title
Subjects' opinion on the acceptability of the medical device
Description
Subjects' opinion on the acceptability of the medical device (cosmetic acceptability and easiness of use)
Time Frame
At Visit 3 (28 days after the end of baseline)
Title
Need of rescue medication
Time Frame
Up to 6 weeks
Title
Adverse events
Time Frame
Up to 6 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José Martinez de Oliveira, MD, PhD
Organizational Affiliation
HPRD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Garcia da Orta, EPE
City
Lisboa
State/Province
Almada
ZIP/Postal Code
2805-267
Country
Portugal
Facility Name
Centro Hospitalar Cova da Beira EPE
City
Covilhã
State/Province
Castelo Branco
ZIP/Postal Code
6200-251
Country
Portugal
Facility Name
Apomédica - Serviços Médicos Ltd
City
Póvoa de Varzim
State/Province
Porto
ZIP/Postal Code
4490-405
Country
Portugal
Facility Name
Unidade Local de Saúde de Matosinhos
City
Matosinhos
State/Province
Senhora Da Hora
ZIP/Postal Code
4464-513
Country
Portugal
Facility Name
Centro Hospitalar de S. João EPE
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Facility Name
Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E
City
Vila Nova de Gaia
ZIP/Postal Code
4400-129
Country
Portugal
12. IPD Sharing Statement
Learn more about this trial
Effectiveness and Tolerability of LabiaStick#01 in Subjects With Symptomatic Non-hypertrophic Chronic Vulvar Dermatoses
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