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

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.

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