- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02541721
Effectiveness and Tolerability of LabiaStick#01 in Subjects With Symptomatic Non-hypertrophic Chronic Vulvar Dermatoses
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 Overview
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Porto, Portugal, 4200-319
- Centro Hospitalar de S. João EPE
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Vila Nova de Gaia, Portugal, 4400-129
- Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E
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Almada
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Lisboa, Almada, Portugal, 2805-267
- Hospital Garcia da Orta, EPE
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Castelo Branco
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Covilhã, Castelo Branco, Portugal, 6200-251
- Centro Hospitalar Cova da Beira EPE
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Porto
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Póvoa de Varzim, Porto, Portugal, 4490-405
- Apomédica - Serviços Médicos Ltd
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Senhora Da Hora
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Matosinhos, Senhora Da Hora, Portugal, 4464-513
- Unidade Local de Saúde de Matosinhos
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: LabiaStick#01
Each participant will have an at least 2-week baseline period followed by a 4-week treatment period with LabiaStick#01.
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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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reduction on subject's vulvar pruritus score
Time Frame: 14 days during run-in period and 14 days during treatment period
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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.
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14 days during run-in period and 14 days during treatment period
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reduction on subject's vulvar burning sensation score
Time Frame: During 4 weeks
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Reduction on subject's vulvar burning sensation score assessed on a 100-mm Visual Analogue Scale (Burning VAS).
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During 4 weeks
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Clinical Global Impression of Change (CGI-C)
Time Frame: At Visit 3 (28 days after the end of baseline)
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At Visit 3 (28 days after the end of baseline)
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Patient Global Impression of Change (PGI-C)
Time Frame: At Visit 3 (28 days after the end of baseline)
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At Visit 3 (28 days after the end of baseline)
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Subjects' opinion on the acceptability of the medical device
Time Frame: At Visit 3 (28 days after the end of baseline)
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Subjects' opinion on the acceptability of the medical device (cosmetic acceptability and easiness of use)
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At Visit 3 (28 days after the end of baseline)
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Need of rescue medication
Time Frame: Up to 6 weeks
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Up to 6 weeks
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Adverse events
Time Frame: Up to 6 weeks
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Up to 6 weeks
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: José Martinez de Oliveira, MD, PhD, HPRD
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LF-01-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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