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

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ClinicalTrials.gov Identifier: NCT02854670
Recruitment Status : Unknown
Verified August 2017 by Centre Hospitalier Universitaire de Besancon.
Recruitment status was:  Recruiting
First Posted : August 3, 2016
Last Update Posted : August 9, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Vestibulodynia Drug: Capsaicin patch Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2016
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Capsaicin

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.




Primary Outcome Measures :
  1. Pain assessment with Visual Analogic Scale (using a q-tip) [ Time Frame: week 12 ]
    Assessment of provoked pain with Visual Analogic Scale (using a q-tip)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02854670


Contacts
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Contact: Fabien Pelletier, MD fabien.pelletier@univ-fcomte.fr

Locations
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France
CHU Besançon Recruiting
Besançon, France, 25000
Contact: Fabien Pelletier, MD       fabien.pelletier@univ-fcomte.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Investigators
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Principal Investigator: Fabien Pelletier, MD CHU Besançon

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Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT02854670     History of Changes
Other Study ID Numbers: P/2013/199
First Posted: August 3, 2016    Key Record Dates
Last Update Posted: August 9, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Centre Hospitalier Universitaire de Besancon:
capsaicin
pain improvement
provoked vulvodynia
Additional relevant MeSH terms:
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Vulvodynia
Vulvar Vestibulitis
Vulvar Diseases
Genital Diseases, Female
Vulvitis
Capsaicin
Antipruritics
Dermatologic Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs