Noritate (Metronidazole Topical) - Summary

NORITATE SUMMARY

Metronidazole Cream, 1%

NORITATE® (metronidazole cream) Cream, 1%, contains metronidazole, USP. Metronidazole is a member of the imidazole class of anti-bacterial agents and is classified as an antiprotozoal and anti-bacterial agent.

NORITATE is indicated for the topical treatment of inflammatory lesions and erythema of rosacea.

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NEWS HIGHLIGHTS

Published Studies Related to Noritate (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...

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Clinical Trials Related to Noritate (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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PATIENT REVIEWS / RATINGS / COMMENTS

Noritate review by 51 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		rash under nasal area
Dosage & duration:		1% cream applied once daily (dosage frequency: daily) for the period of one week
Other conditions:		slight/occasional acne
Other drugs taken:		tetracycline as needed
		Reported Results
Benefits:		I had the drug initally offered to me by my dermatologist in sample tube years ago. I found it very effective, despite only dabbing on the smallest amount due to only having small sample tube. Yet despite quick clear-ups...I would occasionally have recurrances under my nose with the rash. I have struggled with this rash for over 20 years. With the last outbreak, while having minimal amounts left in the sample tube, I went in to my dermatologist and got a full prescription in about June of 2009. Not only was I able to use a bit more in application this time, but it obviously was not an expired product. I found the long-term rash hsf completely cleared up within less than a week. While this was not new to me with this product, the fact that I have had no recurrance whatsoever in over four months is the great news.
Side effects:		Absolutely none
Comments:		After washing my face with my long-term personal choice of face wash (Alpha Hydrox foaming face wash) and using a Strident sensitive skin cleaning pad, I would apply the Noritate cream sparingly over the rash under my nose at night. (Note: I did not use the tetracycline during this time, as I knew it was not an acne-related outbreak.)