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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02197182
Recruitment Status : Terminated (Not for safety reasons)
First Posted : July 22, 2014
Last Update Posted : April 5, 2018
Sponsor:
Information provided by (Responsible Party):
CDA Research Group, Inc.

Study Description
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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..

Condition or disease Intervention/treatment Phase
Bacterial Vaginosis (BV) Drug: LUXSOL copper containing cream Drug: Metronidazole gel Early Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : June 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaginal Diseases

Arms and Interventions
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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 Name: 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 Name: Metrogel


Outcome Measures
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Primary Outcome Measures :
  1. Presence or absence of bacterial vaginosis at the end of the study [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02197182


Locations
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United States, Michigan
Harper University Hospital Department of Infectious Diseases
Detroit, Michigan, United States, 48201
United States, Pennsylvania
Temple University Hospital Department of OB/GYN
Philadelphia, Pennsylvania, United States, 19140
Sponsors and Collaborators
CDA Research Group, Inc.
More Information
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Responsible Party: CDA Research Group, Inc.
ClinicalTrials.gov Identifier: NCT02197182    
Other Study ID Numbers: CDA 0801
First Posted: July 22, 2014    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: March 2015
Keywords provided by CDA Research Group, Inc.:
Bacterial Vaginosis (BV)
Amsel's criteria
Pap smear
Additional relevant MeSH terms:
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Vaginosis, Bacterial
Vaginal Diseases
Bacterial Infections
Bacterial Infections and Mycoses
Infections
Vaginitis
Copper
Metronidazole
 Anti-Infective Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents
Trace Elements
Micronutrients
Physiological Effects of Drugs