METROLOTION SUMMARY
MetroLotion ® (metronidazole lotion) Topical Lotion contains metronidazole, USP, at a concentration of 7.5 mg per gram (0.75% w/w) in a lotion consisting of benzyl alcohol, carbomer 941, cyclomethicone, glycerin, glyceryl stearate, light mineral oil, PEG-100 stearate, polyethylene glycol 400, potassium sorbate, purified water, steareth-21, stearyl alcohol, and sodium hydroxide and/or lactic acid to adjust pH.
MetroLotion ® Topical Lotion is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea.
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NEWS HIGHLIGHTS
Published Studies Related to Metrolotion (Metronidazole Topical)
Controlled study on thymol + eugenol vaginal douche versus econazole in vaginal candidiasis and metronidazole in bacterial vaginosis. [2011]
PURPOSE OF THE STUDY: Bacterial vaginosis (BV) and vaginal candidiasis (VC) are usually managed with topical antibiotics. This study compared the efficacy of a thymol + eugenol vaginal douche (SD) (CAS nr. thymol: 89-83-8 and eugenol: 97-53-0), with econazole (CAS 27220-47-9) in VC and metronidazole (CAS 443-48-1) in BV, as suppository reference therapies. Thymol and eugenol are natural antibacterial and antimycotic active ingredients extracted from plants... CONCLUSION: SD was found to be an effective prescription drug in minor recurrent vaginal infectious episodes and its use can reduce the repeated exposure to antibiotics.
Randomized clinical trial of metronidazole ointment versus placebo in perianal Crohn's disease. [2010.09]
BACKGROUND: The potential for metronidazole 10 per cent ointment to exert therapeutic benefit in perianal Crohn's disease, while minimizing the adverse effects found with oral metronidazole, was evaluated in a randomized placebo-controlled study... CONCLUSION: Metronidazole 10 per cent ointment was not effective in the reduction of PDCAI score, but some secondary outcomes showed improvement suggestive of a treatment effect. It is well tolerated, with minimal adverse effects, and has potential as treatment for pain and discharge associated with perianal Crohn's disease. Registration number: NCT00509639 (http://www.clinicaltrials.gov). Copyright 2010 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.
Efficacy of topical azelaic acid (AzA) gel 15% plus oral doxycycline 40 mg versus metronidazole gel 1% plus oral doxycycline 40 mg in mild-to-moderate papulopustular rosacea. [2010.06]
Rosacea is a leading reason why people seek the care of a dermatologist, accounting for nearly 7 million office visits annually. Pharmacologic treatments include both topical and oral medications, which are increasingly being used in combination, especially at the outset of therapy... These findings warrant further investigation in a sufficiently powered study.
Randomized clinical trial of metronidazole ointment versus placebo in perianal
Crohn's disease. [2010]
placebo-controlled study... CONCLUSION: Metronidazole 10 per cent ointment was not effective in the reduction
Innovative use of topical metronidazole. [2010]
Metronidazole is a synthetic nitroimidazole derivative with antimicrobial and
antiinflammatory properties. It was the first topical therapy approved solely for
rosacea and remains a cornerstone of rosacea management.This article reviews the
optimal use of topical metronidazole in the treatment of rosacea and other
innovative but off-label dermatologic uses reported in the literature.
Clinical Trials Related to Metrolotion (Metronidazole Topical)
An Evaluation of the Cosmetic Appearance of Metronidazole Gel (MetroGel®) 1% [Completed]
The purpose of this study is to determine the cosmetic appearance of metronidazole gel
(MetroGel®) 1% with commonly marketed facial foundations.
A Safety, Tolerability and Pharmacokinetic Study of Two Formulations of Metronidazole Versus Immediate Release Metronidazole in Patient With C. Difficile Colitis [Recruiting]
Clostridium difficile bacteria can be a cause of significant diarrheal disease, particularly
in people who have taken potent antibiotics. When C. difficile multiplies within the colon,
it produces two toxins that cause inflammation and resultant abdominal pain, fever and
diarrhea. Current treatment of mild to moderate disease is with immediate release
metronidazole, an antibiotic that kills C. difficile. Dr. Reddy's Laboratories has
developed a delayed release form of metronidazole to release just before the colon to
increase the concentration of antibiotic in the colon to improve the effectiveness of
metronidazole treatment and potentially to allow less whole body exposure to the antibiotic.
This study will measure the amount of metronidazole in the blood and stool of patients with
C. difficile associated diarrhea (CDAD) to confirm that the new formulations are releasing
the antibiotic as designed, immediately before the colon.
Azithromycin Based Therapy for Induction of Remission in Active Pediatric Crohn's Disease [Recruiting]
The purpose of this study is to evaluate effectiveness of 2 months antibiotic course of
Azithromycin combined with Metronidazole compared with 2 months antibiotic course of
Metronidazole alone.
Efficacy of Metronidazole Versus Metronidazole and Rifampin in CDAD Treatment [Completed]
What is the difference between the use of one drug (Oral Metronidazole) versus the use of
this same drug combined with another drug (Rifampin) in treatment of bacteria and
infection-associated diarrhea in patients? This infection is an important cause of morbidity
and mortality in both the community and hospitals, and the leading cause of hospital and
chronic facility-acquired diarrhea. Research is important for the treatment of this
infection. Patient care with use of two medication treatment regimens will be studied.
Do Motion Metrics Lead to Improved Skill Acquisition on Simulators? [Recruiting]
Emphasizing the growing popularity of motion metrics are the majority of available virtual
reality simulators and some newer hybrid models that offer motion tracking for performance
assessment. A popular hybrid model (PROMIS) allows training with regular laparoscopic
instruments in a box-trainer while automatically recording task duration and movement
efficiency (pathlength and smoothness) that are immediately offered as feedback to
trainees.
Despite the increasing availability of simulators that track motion, our knowledge of the
impact those metrics have on trainee learning is severely limited. We do not know if it is
more important to use speed, accuracy, motion efficiency or a combination thereof for
performance assessment and how these metrics impact skill transfer to the OR.
Based on sound educational principles we have developed a proficiency-based laparoscopic
suturing simulator curriculum. This curriculum focuses on deliberate and distributed
practice, provides trainees with augmented feedback and sets expert-derived performance
goals based on time and errors. We have previously demonstrated that this curriculum leads
to improved operative performance of trainees compared to controls.
To measure operative performance and determine transferability, we will use a live porcine
Nissen fundoplication model. Instead of placing actual patients at risk, the porcine model
is preferable for this purpose as it offers objective metrics (targets are established,
distances measured, knots are disrupted for slippage scoring), complete standardization, and
allows multiple individuals to be tested on the same day.
We hypothesize that proficiency-based simulator training in laparoscopic suturing to
expert-derived levels of speed and motion will result in better operative performance
compared to participants training to levels of speed or motion alone. The study is powered
to detect an at least 10% performance difference between the groups.
Specific Aims
1. Compare whether any performance differences between the groups persist long-term
2. Assess whether the groups demonstrate differences in safety in the operating room by
comparing the inadvertent injuries in the animal OR between the groups
3. Identify the training duration required by novices to reach proficiency in laparoscopic
suturing based on speed, motion efficiency, or a combination of these metrics
4. Identify any baseline participant characteristics that may predict individual
metric-specific performance
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