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

Information source: CDA Research Group, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bacterial Vaginosis (BV)

Intervention: LUXSOL copper containing cream (Drug); Metronidazole gel (Drug)

Phase: Phase 0

Status: Suspended

Sponsored by: CDA Research Group, Inc.


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..

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Presence or absence of bacterial vaginosis at the end of the study

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.


Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Female.


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


- 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


- 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


- 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

Locations and Contacts

Harper University Hospital Department of Infectious Diseases, Detroit, Michigan 48201, United States

Temple University Hospital Department of OB/GYN, Philadelphia, Pennsylvania 19140, United States

Additional Information

Starting date: June 2014
Last updated: March 20, 2015

Page last updated: August 23, 2015

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