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

Phase 2

Terminated

• Conditions: Vestibulodynia
• Interventions: Drug: Capsaicin patch

• Registration Number: NCT02854670
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-20
• Study First Submitted: 2016-08-01
• Study First Submitted QC: 2016-08-02
• Study First Posted: 2016-08-03
• Primary Completion: 2021-02-03
• Study Completion: 2021-02-03
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-09
• Last Update Posted: 2022-11-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Pain assessment with Visual Analogic Scale (using a q-tip)	week 12	Assessment of provoked pain with Visual Analogic Scale (using a q-tip)

Trial Locations

Locations (1)

CHU Besançon; 🇫🇷 Besançon, France