Effectiveness and Tolerability of LabiaStick#01 in Subjects With Symptomatic Non-hypertrophic Chronic Vulvar Dermatoses
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02541721|
Recruitment Status : Terminated (New study design will be made)
First Posted : September 4, 2015
Last Update Posted : February 22, 2018
|Condition or disease||Intervention/treatment||Phase|
|Chronic Disease of Skin||Device: LabiaStick#01||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||September 2015|
|Actual Primary Completion Date :||January 2018|
|Actual Study Completion Date :||January 2018|
Each participant will have an at least 2-week baseline period followed by a 4-week treatment period with 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.
- 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.
- 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 ]
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
|Hospital Garcia da Orta, EPE|
|Lisboa, Almada, Portugal, 2805-267|
|Centro Hospitalar Cova da Beira EPE|
|Covilhã, Castelo Branco, Portugal, 6200-251|
|Apomédica - Serviços Médicos Ltd|
|Póvoa de Varzim, Porto, Portugal, 4490-405|
|Unidade Local de Saúde de Matosinhos|
|Matosinhos, Senhora Da Hora, Portugal, 4464-513|
|Centro Hospitalar de S. João EPE|
|Porto, Portugal, 4200-319|
|Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E|
|Vila Nova de Gaia, Portugal, 4400-129|
|Principal Investigator:||José Martinez de Oliveira, MD, PhD||HPRD|