Clinical trial NCT02541721: 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
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Disease of Skin
Lead sponsor: Health Products Research and Development Lda.
Sponsor class: OTHER
Collaborators: name: Blueclinical, Ltd.
First posted: 2015-09-04
Enrollment: 3
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Reduction on subject's vulvar pruritus score
timeFrame: 14 days during run-in period and 14 days during treatment period
Secondary outcomes:
measure: Reduction on subject's vulvar burning sensation score
timeFrame: During 4 weeks
measure: Clinical Global Impression of Change (CGI-C)
timeFrame: At Visit 3 (28 days after the end of baseline)
measure: Patient Global Impression of Change (PGI-C)
timeFrame: At Visit 3 (28 days after the end of baseline)
measure: Subjects' opinion on the acceptability of the medical device
timeFrame: At Visit 3 (28 days after the end of baseline)
measure: Need of rescue medication
timeFrame: Up to 6 weeks
measure: Adverse events
timeFrame: Up to 6 weeks
Other outcomes:
Locations:
city: Lisboa
country: Portugal
facility: Hospital Garcia da Orta, EPE
state: Almada
city: Covilhã
country: Portugal
facility: Centro Hospitalar Cova da Beira EPE
state: Castelo Branco
city: Póvoa de Varzim
country: Portugal
facility: Apomédica - Serviços Médicos Ltd
state: Porto
city: Matosinhos
country: Portugal
facility: Unidade Local de Saúde de Matosinhos
state: Senhora Da Hora
city: Porto
country: Portugal
facility: Centro Hospitalar de S. João EPE
city: Vila Nova de Gaia
country: Portugal
facility: Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E
Study officials:
affiliation: HPRD
name: José Martinez de Oliveira, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: