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

CDA Research Group

Status and phase: Terminated; Early Phase 1

Conditions: Bacterial Vaginosis (BV)

Treatments: Drug: Metronidazole gel; Drug: LUXSOL copper containing cream

Study type: Interventional

Funder types: Industry

Identifiers

NCT02197182

CDA 0801

Details and patient eligibility

About

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..

Full 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.

Enrollment: 50 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

LUXSOL Cream

Experimental group

Description:

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

Treatment:

Drug: LUXSOL copper containing cream

Metronidazole cream

Active Comparator group

Description:

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.

Treatment:

Drug: Metronidazole gel