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)
Gingival crevicular fluid levels of aspartate aminotransferase and alpha2-macroglobulin before and after topical application of metronidazole or scaling and root planing. [2008.05]
CONCLUSIONS: These data suggest that Alpha2-macroglobulin reflects clinical changes better than AST and that metronidazole and scaling and root planing have the same influence on clinical outcome and biochemical variables in the gingival crevicular fluid.
Is metronidazole 0.75% gel effective in the treatment of seborrhoeic dermatitis? A double-blind, placebo controlled study. [2007.07]
The study aimed to evaluate the effectiveness of metronidazole 0.75% gel in patients with mild and moderate seborrhoeic dermatitis. Sixty-seven patients with seborrhoeic dermatitis were enrolled... In conclusion, in the treatment of seborrhoeic dermatitis, administration of metronidazole 0.75% gel is well tolerated but it is only as effective as placebo and the disease severity quickly returns to the basal levels after the cessation of treatment.
Cumulative irritation potential among metronidazole gel 1%, metronidazole gel 0.75%, and azelaic acid gel 15%. [2007.04]
Topical therapy for rosacea aims to reduce inflammatory lesions and decrease erythema but can carry side effects such as stinging, pruritus, and burning... Metronidazole gel 1% had a similar profile to white petrolatum.
The CLEAR trial: results of a large community-based study of metronidazole gel in rosacea. [2007.01]
A phase 4, open-label, multicenter, community-based study was conducted in subjects with mild to moderately severe papulopustular rosacea of various etiologies and locations to identify subgroups particularly responsive to twice-daily application of metronidazole topical gel 0.75% to the affected areas of the face...
A novel aqueous metronidazole 1% gel with hydrosolubilizing agents (HSA-3). [2006.04]
Rosacea is a common chronic dermatosis that often is characterized by the presence of facial erythema, visible blood vessels, papules, and pustules. Because the face is the predominant site of involvement, rosacea may cause serious psychologic trauma and can significantly affect the quality of life of individuals with the condition...
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.
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.
Sequential Vaccinations in Prostate Cancer Patients [Active, not recruiting]
This study will evaluate, in two parts, the safety and effectiveness of vaccinations against
prostate cancer in patients with disease that has recurred or metastasized (spread beyond the
primary site) following standard treatment. The vaccine consists of three parts, or
ingredients. Part 1 is derived from the vaccinia virus, which has been used for many years
against smallpox. Part 2 is made from a related virus called fowlpox. Two kinds of human DNA
are put inside some of the vaccinia and fowlpox viruses-one produces PSA protein, which is
made by prostate cancer cells; the other produces various proteins called Tricom that enhance
immune activity. Part 3 of the vaccine involves a protein called Sargramostin (also called
granulocyte-macrophage colony stimulating factor, or GM-CSF), which boosts the immune system.
An experimental form of Sargramostin, in which the human DNA for GM-CSF is put inside the
fowlpox virus, is included in the regimen. Stage 1 of the study will examine the safety of
the vaccine and Stage 2 will examine its ability to produce an immune response against tumor
cells.
Patients 18 years of age or older with recurrent or metastatic prostate cancer may be
eligible for this study. Candidates will be screened with a medical history and physical
examination, blood and urine tests, and imaging studies, including computed tomography (CT)
of the chest, abdomen and pelvis. Candidates for Stage 2 will have a blood test to determine
tissue type (human leukocyte antigen, or HLA) type. Only patients with HLA-A2 type may
participate in Stage 2. Patients who are allergic to eggs may not participate in either
part.
Part 1 - Safety Study
Patients in Part 1 receive different combinations and dosages of vaccines. The specific
vaccine and dosage for an individual is determined by his or her time of entry in the study.
The first group of 3 to 6 patients receive fowlpox vaccine; group 2 patients receive vaccinia
and fowlpox; group 3, vaccinia, fowlpox and Sargramostin; group 4, vaccinia and fowlpox, and
group 5, vaccinia and fowlpox. All vaccines are injected under the skin. Patients receiving
the vaccinia and fowlpox vaccines have injections of one or the other once every 4 weeks for
3 months. Patients receiving Sargramostin in addition to fowlpox and vaccinia vaccines
receive the Sargramostin injections daily for 4 days, starting with the day of each vaccine
injection.
Part 2 - Immune Response Study
Patients in Part 2 are randomly assigned to one of four treatment groups, consisting of
different combinations or doses of vaccines to test the effects of the vaccines on the immune
system. The course of treatment is similar to that in Part 1. To obtain sufficient numbers of
immune system cells to measure immune response, patients undergo lymphapheresis-a procedure
for collecting lymphocytes (a type of white blood cell)-on days 1 and 85 of the study. For
this procedure, whole blood is collected through a needle in an arm vein and circulated
through a machine that separates it into its components. The lymphocytes are removed, and the
rest of the blood is returned to the patient through the same needle. For patients who do not
have good arm veins, lymphocytes are collected through a central line-a temporary catheter
(plastic tube) that is placed in a large vein in the neck or under the collarbone. Patients
whose disease remains stable and who tolerate the treatments well may continue to receive the
vaccines every 12 weeks. Patients are monitored closely throughout treatment with monthly
blood tests and with x-ray studies-including bone scans and CT scans of the abdomen and
pelvis-every 85 days.
BASIC (Boric Acid, Alternate Solution for Intravaginal Colonization) Study [Recruiting]
Bacterial vaginosis (BV), the world's most common vaginal infection, continues to cost
patients time, energy, comfort and money. BV is associated with increased incidence of
sexually transmitted infections (including HIV), spontaneous abortion, pre-term labour,
post-surgical infections, and endometritis. Current treatment for those women symptomatic
for BV includes both oral and intravaginal antibiotics, such as metronidazole, which have
success rates of 70-80 % at 1 month after treatment. These treatments also have high
recurrence rates (49-66 % at one year after treatment) and side effects (10-20 % of women)
that include secondary vaginal infection with candida. Intravaginal boric acid has been used
for >100 years for the treatment of vaginal infections and is quite commonly prescribed
today as a treatment for BV. It is cheap, easily accessible, easy to use, and is an
effective treatment of other vaginal infections, such as candida. To date, there are no
clinical trials studying the effectiveness of boric acid in the treatment of BV.
Objectives: To determine whether boric acid is at least as effective and as safe as
metronidazole for treating women with symptomatic BV, our study will compare intravaginal
boric acid to the current standard intravaginal treatment, metronidazole, and to a placebo.
Our goal is to expand women's options for the treatment of BV. Hypothesis: Boric acid is an
effective treatment of bacterial vaginosis as compared to placebo. Boric acid is at least
as effective and as safe in the treatment of bacterial vaginosis as compared to
metronidazole.
A Study to Evaluate the Safety and Effectiveness of Ertapenem Versus Ceftriaxone/Metronidazole in the Treatment of Intra-Abdominal Infections in Adults [Completed]
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Page last updated: 2009-10-20
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