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

NCT ID: NCT02197182

Last Updated: 2018-04-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2015-03-31

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.

Conditions

Bacterial Vaginosis (BV)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LUXSOL Cream

LUXSOL Cream is a copper containing cream to be administered intravaginally before bedtime for 10 consecutive nights.

Group Type: EXPERIMENTAL

LUXSOL copper containing cream

Intervention Type: DRUG

Active comparator arm

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.

Group Type: ACTIVE_COMPARATOR

Metronidazole gel

Intervention Type: DRUG

Active comparator for treatment of bacterial vaginosis

Interventions

LUXSOL copper containing cream

Active comparator arm

Intervention Type: DRUG

Metronidazole gel

Active comparator for treatment of bacterial vaginosis

Intervention Type: DRUG

Other Intervention Names

LUXSOL Topical Cream; Metrogel

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

CDA Research Group, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Harper University Hospital Department of Infectious Diseases

Detroit, Michigan, United States

Temple University Hospital Department of OB/GYN

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

CDA 0801

Identifier Type: -

Identifier Source: org_study_id