Status:
TERMINATED
Cold Laser: A Modality to Promote Vulvar Healing and Pain Relief
Lead Sponsor:
ProHealth Care, Inc
Conditions:
Vulvar Vestibulitis
Vestibulodynia
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The objectives of this pilot study are to demonstrate effectiveness of application of the Erchonia Laser (manufactured by Erchonia Corporation),a non-invasive, non-significant risk low level laser red...
Detailed Description
In the current proposed pilot study, application of a low level laser light device, manufactured by Erchonia Corporation, to reduce the pain of vulvar vestibulitis will be evaluated. The Erchonia Lase...
Eligibility Criteria
Inclusion
- • Female
- 18 years or older
- Current diagnosis of provoked or non-provoked vulvar vestibulitis made by a suitably qualified medical professional
- Vulvar pain is chronic, defined as having been present for at least 3 months.
- Visual Analog Score for typical vulvar pain is at least 30/100 Patient has been stabilized on all hormonal interventions (i.e., birth control pills, topical or oral estrogen agents) and will not be altered for the course of the treatment protocol of this study.
- Subject is willing and able to decrease use of current pain relief medication to manage vulvar pain throughout study participation, and is willing and able to refrain from engaging in other non-study treatments to manage her vulvar vestibulitis symptoms
Exclusion
- • Vulvar dermatoses such as lichen sclerosis, squamous cell hyperplasia, or lichen planus
- Active vaginal or pelvic infection, herpetic infections, vulvar cancer and/or treatment for cancer
- Previous vestibulectomy or other surgical or procedural interventions (for vestibulitis ) to the treatment area
- Active infection, wound or other external trauma to the areas to be treated with the laser
- Other neurological disorders such as Multiple Sclerosis
- Photosensitivity disorder
- Pregnant or planning pregnancy prior to study end
- Serious mental health illness, developmental disability or cognitive impairment that may preclude adequate comprehension of the consent form or ability to record study measures
Key Trial Info
Start Date :
March 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT02204319
Start Date
March 1 2014
End Date
July 1 2015
Last Update
July 2 2017
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