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
|Condition or disease||Intervention/treatment||Phase|
|Vestibulodynia||Drug: Capsaicin patch||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||January 2016|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||July 2018|
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.
- 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)
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
|Contact: Fabien Pelletier, MDemail@example.com|
|Besançon, France, 25000|
|Contact: Fabien Pelletier, MD firstname.lastname@example.org|
|Principal Investigator:||Fabien Pelletier, MD||CHU Besançon|