A Study of the Effects of Topical Capsaicin in the Treatment of Provoked Vestibulodynia (NCT02854670) | Clinical Trial Compass
TerminatedPhase 2/3
A Study of the Effects of Topical Capsaicin in the Treatment of Provoked Vestibulodynia
Stopped: Recruitment difficulties
France10 participantsStarted 2016-01-20
Plain-language summary
This study aims to assess the pain on contact in provoked vestibulodynia, measured with Visual Analogic Scale at week 0/week 2/week 6/week 12 after applying a patch of capsaicin.
Who can participate
Age range18 Years – 65 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Provoked vulvodynia, rated B2a according to 2003 International Society for the Study of Vulvovaginal Disease (ISSVD) classification
* Pain ≥ 4 on Visual Analogic Scale (VAS)
* Subject refractory to at least 2 conventional treatments (tricyclic antidepressants, anticonvulsants at analgesic doses , biofeedback physical therapy, psychological assessment in a context of chronic pain) or to botulinum toxin A
* If a former treatment with botulinum toxin A was performed: patient must be in treatment failure (= no decrease over 50% of the pain 3 months after initiation of the treatment)
* Negative screening test results
* Menopause, surgically sterilized women or women using effective contraceptive method
* Good understanding and predictable adherence to the protocol
* Beneficiary/affiliated to French social security/social healthcare
* Signed Informed Consent Form
Exclusion Criteria:
* Predictable poor adherence
* Pregnant or breastfeeding women
* Diabetes mellitus type 1 or type 2
* Major mental disorders
* Underlying etiology such as chronic vulvar disease
* Initial vulvar erythema
* Vulnerable subjects (particularly adults under guardianship)
* Ongoing medical treatment with tricyclic antidepressants or anticonvulsants at analgesic doses
Subject refractory to conventional treatments (tricyclic antidepressants and benzodiazepines doses analgesics, physiotherapy type of biofeedback)
Good understanding and predictable adherence to the protocol beneficiary/…
What they're measuring
1
Pain assessment with Visual Analogic Scale (using a q-tip)
Timeframe: week 12
Trial details
NCT IDNCT02854670
SponsorCentre Hospitalier Universitaire de Besancon