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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-006756-22-BE

Enrollment

Registered

2009-01-09

Start date

2009-07-09

Completion date

Unknown

Last updated

2025-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vulvar vestibulitis syndrome

Interventions

Trade Name: Bio-restorative Skin Cream Product Name: Bio-restorative Skin Cream Pharmaceutical Form: Cutaneous emulsion Pharmaceutical form of the placebo: Cutaneous emulsion Route of administration o

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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. 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? Improvement of quality of life, particularly sex-life safety and absence of adverse effects.	—

Measure

Time frame

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. 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? Improvement of quality of life, particularly sex-life safety and absence of adverse effects.

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Countries

Belgium

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026