Status:
TERMINATED
LUXSOL(TM) Topical Cream for the Treatment of Symptomatic Bacterial Vaginosis; A Proof of Concept Study
Lead Sponsor:
CDA Research Group, Inc.
Conditions:
Bacterial Vaginosis (BV)
Eligibility:
FEMALE
18-80 years
Phase:
EARLY_PHASE1
Brief Summary
LUXSOL Cream may be useful for the treatment of bacterial Vaginosis. In this study, LUXSOL Cream is compared to a control arm group using metronidazole cream. LUXSOL is administered intravaginally for...
Detailed Description
LUXSOL Topical Cream is a copper containing topical cream indicated for the treatment of bacterial vaginosis (BV). The study is an open-label, randomized, controlled study comparing LUXSOL Cream to Me...
Eligibility Criteria
Inclusion
- Subject agrees to participate and signs informed consent
- Female age 18 or older
- Subject has clinical BV with 4 of 4 Amsel's criteria
- Off-white (milky or gray), thin, adherent, homogenous discharge with minimal or absent pruritus and inflammation of the vulva and vagina
- Presence of 'clue cells' \>/=20% of the total epithelial cells on microscopic examination of the saline 'wet mount.'
- Virginal secretion pH of \>4.5
- A fishy odor of the vaginal discharge with the addition of a drop of 10% KOH (i.e. a positive 'whiff test')
- Subject agrees to refrain from use of douches, intravaginal products for treatment period
- Subject agrees to refrain from taking oral or intravaginal antibiotics or antifungal agents during entire study period
- Subject agrees to refrain from vaginal intercourse during treatment period.
Exclusion
- Subject has another infectious or noninfectious cause of vulvovaginitis
- Subject has another vaginal or vulvar condition that would confound the determination of study endpoints.
- Subject has received antifungal or antimicrobial therapy (systemic or intravaginal) within the last 14 days prior to enrollment.
- Subject is under treatment for cervical intra-epithelial neoplasia or cervical carcinoma
- Subject is known to be HIV positive
- Subject has a positive pregnancy test
- Subject has any abnormal anatomy or pathology of the vagina
- Subject has untreated sexually transmitted disease
- Subject is currently having menstrual period or may have her period during treatment days.
- Subject's PAP smear \>/= to LSIL
- Subjects with known sensitivity or allergic reactions to copper or Metronidazole vaginal gel
- Subject has known Wilson's disease
Key Trial Info
Start Date :
June 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT02197182
Start Date
June 1 2014
End Date
March 1 2015
Last Update
April 5 2018
Active Locations (2)
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1
Harper University Hospital Department of Infectious Diseases
Detroit, Michigan, United States, 48201
2
Temple University Hospital Department of OB/GYN
Philadelphia, Pennsylvania, United States, 19140