Bacterial Vaginosis (BV)Early Phase 1NCT02197182
LUXSOL(TM) Topical Cream for the Treatment of Symptomatic Bacterial Vaginosis; A Proof of Concept Study
A Early Phase 1 study testing LUXSOL copper containing cream and Metronidazole gel in people with Bacterial Vaginosis (BV), run by CDA Research Group, Inc. at 2 sites in United States.
Trial 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.. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Bacterial Vaginosis (BV)
- What is being tested?
- LUXSOL copper containing cream and Metronidazole gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2014to Mar 2015
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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 locations and contacts
2 sites in 1 country.
United States2 sites
Harper University Hospital Department of Infectious Diseases
Detroit, Michigan, 48201
Temple University Hospital Department of OB/GYN
Philadelphia, Pennsylvania, 19140
About this study
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
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..
Read the 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.
- Conditions
- Bacterial Vaginosis (BV)
- Being tested
- LUXSOL copper containing cream, Metronidazole gel
- Keywords
- Bacterial Vaginosis (BV), Amsel's criteria, Pap smear
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LUXSOL copper containing creamDrug
Also called LUXSOL Topical Cream
Active comparator arm
Metronidazole gelDrug
Also called Metrogel
Active comparator for treatment of bacterial vaginosis
| Study group | Role | What they receive |
|---|---|---|
| LUXSOL Cream | Experimental | LUXSOL Cream is a copper containing cream to be administered intravaginally before bedtime for 10 consecutive nights. Receives: 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. Receives: Drug: Metronidazole gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2014 (estimated)
- Study startJun 2014
- Primary completionMar 2015
- Study completionMar 2015
Why it stopped: Not for safety reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial Vaginosis (BV)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- CDA Research Group, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02197182
- Sponsor's protocol ID
- CDA 0801
- Status last verified
- Mar 2015
- First submitted
- 20 Jul 2014
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02197182
- Acronym / sponsor ID
- CDA 0801
- Conditions
- Bacterial Vaginosis (BV)
- Keywords
- Bacterial Vaginosis (BV), Amsel's criteria, Pap smear
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not for safety reasons
- Enrolment
- 50 participants (actual)
- Lead sponsor
- CDA Research Group, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 22 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LUXSOL Cream | Experimental | Drug: LUXSOL copper containing creamLUXSOL Cream is a copper containing cream to be administered intravaginally before bedtime for 10 consecutive nights. |
| Metronidazole cream | Active comparator | Drug: Metronidazole gelMetronidazole cream is the active comparator drug to be self-administered intravaginally each night before bedtime for 10 consecutive nights. Dosage is per package insert. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.'
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LUXSOL copper containing creamAlso: LUXSOL Topical CreamActive comparator arm | Drug | LUXSOL Cream |
| Metronidazole gelAlso: MetrogelActive comparator for treatment of bacterial vaginosis | Drug | Metronidazole cream |
Primary outcome
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.
Results and safety
The study was stopped early (reason given: Not for safety reasons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing LUXSOL copper containing cream and Metronidazole gel in people with Bacterial Vaginosis (BV), run by CDA Research Group, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Not for safety reasons). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence or absence of bacterial vaginosis at the end of the study (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2018.