Back to resultsLUXSOL(TM) Topical Cream for the Treatment of Symptomatic Bacterial Vaginosis; A Proof of Concept Study
Primary Purpose
Bacterial Vaginosis (BV)
Status
Terminated
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
LUXSOL copper containing cream
Metronidazole gel
Sponsored by
About this trial
This is an interventional treatment trial for Bacterial Vaginosis (BV) focused on measuring Bacterial Vaginosis (BV), Amsel's criteria, Pap smear
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Harper University Hospital Department of Infectious Diseases
- Temple University Hospital Department of OB/GYN
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
LUXSOL Cream
Metronidazole cream
Arm Description
LUXSOL Cream is a copper containing cream to be administered intravaginally before bedtime for 10 consecutive nights.
Metronidazole cream is the active comparator drug to be self-administered intravaginally each night before bedtime for 10 consecutive nights. Dosage is per package insert.
Outcomes
Primary Outcome Measures
Presence or absence of bacterial vaginosis at the end of the study
Patients will be assessed at day 30 for the presence or absence of bacterial Vaginosis (BV). Absence of BV will be considered a cure.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02197182
Brief Title
LUXSOL(TM) Topical Cream for the Treatment of Symptomatic Bacterial Vaginosis; A Proof of Concept Study
Official Title
An Open-Label, Randomized Study to Determine the Safety and Efficacy of LUXSOL(TM) Cream for the Treatment of Bacterial Vaginosis: A Proof of Concept Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Terminated
Why Stopped
Not for safety reasons
Study Start Date
June 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CDA Research Group, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 10 days, each evening before bedtime to treat bacterial Vaginosis..
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 Metrogel in patients with a diagnosis of BV. The investigational product or the comparator product will be self-administered by the patient for 10 consecutive nights. A successful patient outcome is cured BV at 30 days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Vaginosis (BV)
Keywords
Bacterial Vaginosis (BV), Amsel's criteria, Pap smear
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LUXSOL Cream
Arm Type
Experimental
Arm Description
LUXSOL Cream is a copper containing cream to be administered intravaginally before bedtime for 10 consecutive nights.
Arm Title
Metronidazole cream
Arm Type
Active Comparator
Arm Description
Metronidazole cream is the active comparator drug to be self-administered intravaginally each night before bedtime for 10 consecutive nights. Dosage is per package insert.
Intervention Type
Drug
Intervention Name(s)
LUXSOL copper containing cream
Other Intervention Name(s)
LUXSOL Topical Cream
Intervention Description
Active comparator arm
Intervention Type
Drug
Intervention Name(s)
Metronidazole gel
Other Intervention Name(s)
Metrogel
Intervention Description
Active comparator for treatment of bacterial vaginosis
Primary Outcome Measure Information:
Title
Presence or absence of bacterial vaginosis at the end of the study
Description
Patients will be assessed at day 30 for the presence or absence of bacterial Vaginosis (BV). Absence of BV will be considered a cure.
Time Frame
30 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Facility Information:
Facility Name
Harper University Hospital Department of Infectious Diseases
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Temple University Hospital Department of OB/GYN
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
12. IPD Sharing Statement
Learn more about this trial
LUXSOL(TM) Topical Cream for the Treatment of Symptomatic Bacterial Vaginosis; A Proof of Concept Study
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