LUXSOL(TM) Topical Cream for the Treatment of Symptomatic Bacterial Vaginosis; A Proof of Concept Study
- Conditions
- Bacterial Vaginosis (BV)
- Interventions
- Drug: LUXSOL copper containing cream
- Registration Number
- NCT02197182
- Lead Sponsor
- CDA Research Group, Inc.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 50
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Metronidazole cream Metronidazole gel 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. LUXSOL Cream LUXSOL copper containing cream LUXSOL Cream is a copper containing cream to be administered intravaginally before bedtime for 10 consecutive nights.
- Primary Outcome Measures
Name Time Method Presence or absence of bacterial vaginosis at the end of the study 30 days 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
Name Time Method
Trial Locations
- Locations (2)
Temple University Hospital Department of OB/GYN
🇺🇸Philadelphia, Pennsylvania, United States
Harper University Hospital Department of Infectious Diseases
🇺🇸Detroit, Michigan, United States