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

NCT02854670 | Terminated Phase 2 DMC

• 1 other identifier: P/2013/199
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Vestibulodynia

Keywords

capsaicin; pain improvement; provoked vulvodynia

Outcome Measures

Primary Outcomes (1)

• Pain assessment with Visual Analogic Scale (using a q-tip)

  Assessment of provoked pain with Visual Analogic Scale (using a q-tip)

  week 12

Study Arms (1)

Capsaicin patch

EXPERIMENTAL

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

Drug: Capsaicin patch

Interventions

Capsaicin patch DRUG

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

Capsaicin patch

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (1)

CHU Besançon

Besançon, 25000, France

Location

MeSH Terms

Conditions

Vulvodynia

Condition Hierarchy (Ancestors)

Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Fabien Pelletier, MD

  CHU Besançon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2016
• First Posted: August 3, 2016
• Study Start: January 20, 2016
• Primary Completion: February 3, 2021
• Study Completion: February 3, 2021
• Last Updated: November 14, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)