A Study of the Effects of Topical Capsaicin in the Treatment of Provoked Vestibulodynia

Study Overview
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Brief Summary
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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.

Conditions
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Vestibulodynia

Intervention / Treatment
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* Drug: Capsaicin patch


Participation Criteria
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Eligibility Criteria
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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/affiliated to French social security/social healthcare signed Informed Consent Form

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Capsaicin patch<br>Cuttable capsaicin patch. 2 patches of 4 cm² (2 x 2cm), for a total of 2.5 mg of capsaicin. | Drug: Capsaicin patch<br>* After a pre-medication with paracetamol, patches are applied and removed after 20 minutes. Patients remain under observation for 2 hours after removal.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain assessment with Visual Analogic Scale (using a q-tip) | Assessment of provoked pain with Visual Analogic Scale (using a q-tip) | week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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capsaicin, pain improvement, provoked vulvodynia