Clinical trial NCT02197182: 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
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Bacterial Vaginosis (BV)
Keywords: Bacterial Vaginosis (BV)
Amsel's criteria
Pap smear
Lead sponsor: CDA Research Group, Inc.
Sponsor class: INDUSTRY
First posted: 2014-07-22
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Presence or absence of bacterial vaginosis at the end of the study
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Harper University Hospital Department of Infectious Diseases
state: Michigan
city: Philadelphia
country: United States
facility: Temple University Hospital Department of OB/GYN
state: Pennsylvania
Study officials:
References: