LUXSOL(TM) Topical Cream for the Treatment of Symptomatic... | NCT02197182

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

NCT02197182

Sponsor

CDA Research Group, Inc.

Status

Terminated

Last Update Posted

Apr 5, 2018Actual

Enrollment

50Actual

Phase

Early Phase 1

Conditions

Bacterial Vaginosis (BV)

Interventions

LUXSOL copper containing cream
Metronidazole gel

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not for safety reasons

Expanded Access Info

Start Date

Jun 2014

Primary Completion Date

Mar 2015Actual

Completion Date

Mar 2015Actual

First Submitted Date

Jul 20, 2014

First Submission Date that Met QC Criteria

Jul 21, 2014

First Posted Date

Jul 22, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 4, 2018

Last Update Posted Date

Apr 5, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
LUXSOL Cream	Experimental	LUXSOL Cream is a copper containing cream to be administered intravaginally before bedtime for 10 consecutive nights.	Drug: LUXSOL copper containing cream
Metronidazole cream	Active Comparator	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LUXSOL copper containing cream	Drug	Active comparator arm	LUXSOL Cream

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections
D014627	Vaginitis

ID	Term
D009593	Nitroimidazoles
D009574	Nitro Compounds
D009930	Organic Chemicals
D007093	Imidazoles