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

Sponsor

Centre Hospitalier Universitaire de Besancon (Other)

Overall Status

Unknown status

CT.gov ID

NCT02854670

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vestibulodynia	Drug: Capsaicin patch	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Study Start Date :

Jan 1, 2016

Anticipated Primary Completion Date :

Jul 1, 2018

Anticipated Study Completion Date :

Jul 1, 2018

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Capsaicin patch

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

Drug: Capsaicin patch

After a pre-medication with paracetamol, patches are applied and removed after 20 minutes. Patients remain under observation for 2 hours after removal.

Outcome Measures

Primary Outcome Measures

Pain assessment with Visual Analogic Scale (using a q-tip) [week 12]
Assessment of provoked pain with Visual Analogic Scale (using a q-tip)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts 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