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

Stopped early · Early Phase 1

Conditions studied: Bacterial Vaginosis (BV)

In brief

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..

Key facts

Study ID

NCT02197182

Run by

CDA Research Group, Inc.

People needed

50

Starts

2014-06-01

Expected to finish

2015-03-01

Last updated by the study team

2018-04-05

Who can join

Age: 18 and older, up to 80. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Harper University Hospital Department of Infectious Diseases — Detroit, Michigan, United States
• Temple University Hospital Department of OB/GYN — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.