Chronic Disease of SkinNCT02541721
Effectiveness and Tolerability of LabiaStick#01 in Subjects With Symptomatic Non-hypertrophic Chronic Vulvar Dermatoses
A study testing LabiaStick#01 in people with Chronic Disease of Skin, run by Health Products Research and Development Lda. at 6 sites in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Chronic Disease of Skin
- What is being tested?
- LabiaStick#01
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 6 sitesPortugal
- Study dates
- Sep 2015to Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Portugal6 sites
Centro Hospitalar Cova da Beira EPE
Covilha, Castelo Branco District, 6200-251
Hospital Garcia da Orta, EPE
Lisbon, Almada, 2805-267
Unidade Local de Saúde de Matosinhos
Matosinhos Municipality, Senhora Da Hora, 4464-513
Centro Hospitalar de S. João EPE
Porto, 4200-319
Apomédica - Serviços Médicos Ltd
Póvoa de Varzim, Porto District, 4490-405
Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E
Vila Nova de Gaia, 4400-129
About this study
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
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.
Read the 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.
- Conditions
- Chronic Disease of Skin
- Being tested
- LabiaStick#01
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LabiaStick#01Device
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.
| Study group | Role | What they receive |
|---|---|---|
| LabiaStick#01 | Experimental | Each participant will have an at least 2-week baseline period followed by a 4-week treatment period with LabiaStick#01. Receives: Device: LabiaStick#01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 days during run-in period and 14 days during treatment period
Secondary outcomes (6)
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).
Measured: During 4 weeks
Clinical Global Impression of Change (CGI-C)
Measured: At Visit 3 (28 days after the end of baseline)
Patient Global Impression of Change (PGI-C)
Measured: At Visit 3 (28 days after the end of baseline)
Subjects' opinion on the acceptability of the medical device
Subjects' opinion on the acceptability of the medical device (cosmetic acceptability and easiness of use)
Measured: At Visit 3 (28 days after the end of baseline)
Need of rescue medication
Measured: Up to 6 weeks
Adverse events
Measured: Up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionJan 2018
- Study completionJan 2018
Why it stopped: New study design will be made
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Disease of SkinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Health Products Research and Development Lda.
- Sponsor type
- University, hospital or other
- Collaborators
- Blueclinical, Ltd.
- Responsible party
- Sponsor
- Investigators
- José Martinez de Oliveira, MD, PhD, Principal investigator, HPRD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02541721
- Sponsor's protocol ID
- LF-01-01
- Status last verified
- Feb 2018
- First submitted
- 2 Sep 2015
- Last updated
- 22 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02541721
- Acronym / sponsor ID
- LF-01-01
- Conditions
- Chronic Disease of Skin
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: New study design will be made
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Health Products Research and Development Lda.University, hospital or other
- Collaborators
- Blueclinical, Ltd.
- Study start
- Sep 2015
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 4 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LabiaStick#01 | Experimental | Device: LabiaStick#01Each participant will have an at least 2-week baseline period followed by a 4-week treatment period with LabiaStick#01. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LabiaStick#01This 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. | Device | LabiaStick#01 |
Primary outcome
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.
6 secondary outcomes
Reduction on subject's vulvar burning sensation score
Time frame: During 4 weeks
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)
Need of rescue medication
Time frame: Up to 6 weeks
Adverse events
Time frame: Up to 6 weeks
Results and safety
The study was stopped early (reason given: New study design will be made). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José Martinez de Oliveira, MD, PhD principal investigator
HPRD
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LabiaStick#01 in people with Chronic Disease of Skin, run by Health Products Research and Development Lda. at 6 sites in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: New study design will be made). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction on subject's vulvar pruritus score (time frame: 14 days during run-in period and 14 days during treatment period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2018.