LUXSOL(TM) Topical Cream for the Treatment of Symptomatic Bacterial Vaginosis; A Proof of Concept Study

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

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..

Study Overview

• Status: Terminated
• Conditions: Bacterial Vaginosis (BV)
• Intervention / Treatment: Drug: LUXSOL copper containing cream; Drug: Metronidazole gel

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Harper University Hospital Department of Infectious Diseases
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University Hospital Department of OB/GYN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LUXSOL Cream; LUXSOL Cream is a copper containing cream to be administered intravaginally before bedtime for 10 consecutive nights.	Drug: LUXSOL copper containing cream; Active comparator arm; Other Names: LUXSOL Topical Cream
Active Comparator: Metronidazole cream; 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.	Drug: Metronidazole gel; Active comparator for treatment of bacterial vaginosis; Other Names: Metrogel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 days

Collaborators and Investigators

• Sponsor: CDA Research Group, Inc.

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: July 20, 2014
• First Submitted That Met QC Criteria: July 21, 2014
• First Posted (Estimate): July 22, 2014

Study Record Updates

• Last Update Posted (Actual): April 5, 2018
• Last Update Submitted That Met QC Criteria: April 4, 2018
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Pap smear; Bacterial Vaginosis (BV); Amsel's criteria
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Vaginitis; Vaginal Diseases; Vaginosis, Bacterial; Physiological Effects of Drugs; Anti-Infective Agents; Trace Elements; Micronutrients; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Copper; Metronidazole
• Other Study ID Numbers: CDA 0801