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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-20

Study Completion Date

2021-02-03

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.

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Detailed Description

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Conditions

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Vestibulodynia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Capsaicin patch

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

Group Type EXPERIMENTAL

Capsaicin patch

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No