A Study of the Effects of Topical Capsaicin in the Treatment of Provoked Vestibulodynia (CAPSIVU)

Centre Hospitalier Universitaire de Besancon

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Vestibulodynia

Treatments: Drug: Capsaicin patch

Study type: Interventional

Funder types: Other

Identifiers

NCT02854670

P/2013/199

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Capsaicin patch

Experimental group

Description:

Cuttable capsaicin patch. 2 patches of 4 cm² (2 x 2cm), for a total of 2.5 mg of capsaicin.

Treatment:

Drug: Capsaicin patch