VVS study: the efficacy and safety of Bio-restorative Skin Cream in the local treatment of vulvar vestibulitis syndrome (VVS) compared with placebo. - VVS study

Conditions: Vulvar vestibulitis syndrome

Registration Number: EUCTR2008-006756-22-BE

Lead Sponsor: eocutis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: 30

Inclusion Criteria

age between 18 and 50
minimum 6 months suffering of VVS
Visible redness of the vestibule (5 and 7 and/or 1 and 11 o clock)
good general health
not pregnant or becoming pregnant during the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Use of corticoids, anti-inflammatory or immunosuppressive medication during the last two weeks before study entry.
Previous extensive vestibular surgery.
Suffering chronic diseases that need long term treatment.
Use of spermacides as a contraception
needing suplemental treatment for acute vulvovaginitis.
No use of other vestibulitis medications and treatments

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To study the efficacy of a cytokine cream (Bio-restorative skin cream) in treating vulvar vestibulitis syndrome as compared to its placebo (Bio-restorative skin cream without cytokines).;Secondary Objective: To evaluate safety and tolerability of the cream during three months use.<br>To prove statistical decrease of symptoms of VVS during the use of the cytikine cream, compared to the use of placebo.;Primary end point(s): Reduction of measured vulvar pain in 70% of patients?<br>Improvement of quality of life, particularly sex-life<br>safety and absence of adverse effects.<br>

Secondary Outcome Measures