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Mycolog-II (Nystatin / Triamcinolone Acetonide Topical) - Summary

 
 



MYCOLOG-II SUMMARY

MYCOLOG®-II
Nystatin and Triamcinolone Acetonide Cream USP

MYCOLOG-II Cream (Nystatin and Triamcinolone Acetonide Cream) for dermatologic use contains the antifungal agent nystatin and the synthetic corticosteroid triamcinolone acetonide. Nystatin is a polyene antimycotic obtained from Streptomyces noursei. It is a yellow to light tan powder with a cereal-like odor, very slightly soluble in water, and slightly to sparingly soluble in alcohol.

MYCOLOG-II (Nystatin and Triamcinolone Acetonide Cream) is indicated for the treatment of cutaneous candidiasis; it has been demonstrated that the nystatin-steroid combination provides greater benefit than the nystatin component alone during the first few days of treatment.


See all Mycolog-II indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Mycolog-II (Nystatin / Triamcinolone Topical)

The significance of ethylenediamine hydrochloride dermatitis caused by a "generic" nystatin-triamcinolone II cream. [1988.04]
Generic Myco-Triacet II Cream would seem to be analogous to Mycolog II Cream. However, Myco-Triacet II Cream still contains the common and potent sensitizer, ethylenediamine hydrochloride, which is no longer present in Mycolog II Cream.This is another instance in which a rose by an other name does not smell as sweet.

more studies >>

Clinical Trials Related to Mycolog-II (Nystatin / Triamcinolone Topical)

A Pilot Study of Peribulbar Triamcinolone Acetonide for Diabetic Macular Edema [Completed]
The study involves the enrollment of patients over 18 years of age with diabetic macular edema involving the center of the macula who have not already been given maximal laser treatment.

Patients with one study eye will be randomly assigned (stratified by prior laser) with equal probability to one of five treatment groups:

1. Focal laser photocoagulation (modified ETDRS technique)

2. Posterior peribulbar injection of 40 mg triamcinolone (Kenalog)

3. Anterior peribulbar injection of 20 mg triamcinolone

4. Posterior peribulbar injection of 40 mg triamcinolone followed after one month by laser

5. Anterior peribulbar injection of 20 mg triamcinolone followed after one month by laser

For patients with two study eyes (both eyes eligible at the time of randomization), the right eye (stratified by prior laser) will be randomly assigned with equal probabilities to one of the five treatment groups listed above. If the right eye was assigned to laser only, then the left eye will be assigned to one of the four triamcinolone groups above with equal probability (stratified by prior laser). If the right eye was assigned to receive triamcinolone, then the left eye will receive laser only.

Triamcinolone acetonide will be the corticosteroid utilized in this study. The triamcinolone acetonide preparation to be used is Kenalog. Kenalog is manufactured by Bristol Myers Squibb and is approved by the Food and Drug Administration for intramuscular use for a variety of indications. Peribulbar injections of Kenalog have been used for a wide variety of ocular conditions, particularly uveitis and post-cataract extraction cystoid macular edema, for many years.

Two different triamcinolone regimens will be assessed in the study: 40 mg injected posteriorly and 20 mg injected anteriorly. There is no indication of which treatment regimen will be better. Although the injection behind the eye is more common than the injection near the front of the eye, the injection near the front of the eye has less risk of injuring the eye. However, it is possible that the injection near the front of the eye may increase eye pressure more frequently. Little is known about which of the two injections decreases macular edema and improves vision more often.

Patients enrolled into the study will be followed for three years and will have study visits 1 month, 2 months, 4 months, 8 months and annually after receiving their assigned study treatment. For the first 8 months of the study, patients should only be retreated with their randomized treatment. However, if the patient's visual acuity has decreased by 15 letters or more, then any treatment may be given at the investigator's discretion. After completion of the 8-month visit, treatment is at investigator discretion.

The primary objective of this study is to obtain estimates of efficacy and safety outcomes for each of the treatment groups. These estimates will provide a basis for the sample size estimation and hypothesis generation in a phase III trial.

Intravitreal Triamcinolone Acetonide Versus Laser for Diabetic Macular Edema [Active, not recruiting]
The study involves the enrollment of patients over 18 years of age with diabetic macular edema. Patients with one study eye will be randomly assigned (stratified by visual acuity and prior laser) with equal probability to one of the three treatment groups:

1. Laser photocoagulation

2. 1mg intravitreal triamcinolone acetonide injection

3. 4mg intravitreal triamcinolone acetonide injection

For patients with two study eyes (both eyes eligible at the time of randomization), the right eye (stratified by visual acuity and prior laser) will be randomly assigned with equal probabilities to one of the three treatment groups listed above. The left eye will be assigned to the alternative treatment (laser or triamcinolone). If the left eye is assigned to triamcinolone, then the dose (1mg or 4 mg) will be randomly assigned to the left eye with equal probability (stratified by visual acuity and prior laser).

The study drug, triamcinolone acetonide, has been manufactured as a sterile intravitreal injectable by Allergan. Study eyes assigned to an intravitreal triamcinolone injection will receive a dose of either 1mg or 4mg. There is no indication of which treatment regimen will be better.

Patients enrolled into the study will be followed for three years and will have study visits every 4 months after receiving their assigned study treatment. In addition, standard of care post-treatment visits will be performed at 4 weeks after each intravitreal injection.

A Multicentre Randomised Clinical Trial of Laser Treatment Plus Intravitreal Triamcinolone for Diabetic Macular Oedema [Recruiting]
This study is likely to identify an improved and economical treatment for diabetic macular oedema, one of the commonest causes of blindness both in Australia and the rest of the world. The specific aims of the study are to test the following hypotheses:

- That intravitreal triamcinolone followed by laser treatment results in a greater

improvement in visual acuity than placebo followed by laser treatment of eyes with macular oedema secondary to diabetes;

- That intravitreal triamcinolone followed by laser treatment results in greater degree

of resolution of macular oedema than placebo followed by laser treatment of eyes with macular oedema secondary to diabetes;

- That intravitreal triamcinolone followed by laser treatment results in a reduced

requirement for further laser treatment to control diabetic macular oedema than placebo followed by laser treatment;

- That intravitreal triamcinolone followed laser has a manageable and acceptable safety

profile in eyes with diabetic macular edema.

Treatment of Bevacizumab and Triamcinolone in Treatment or Macular Edema Secondary to CRVO [Recruiting]
Treatment of macular edema secondary to central retinal vein occlusion is more effective with combined therapy of bevacizumab and triamcinolone than bevacizumab alone.

Open Label Extension of a Clinical Trial of Intravitreal Triamcinolone for Diabetic Macular Oedema-TDMX Study [Active, not recruiting]
This open label extension will treat all the eyes of study participants with active study medication (intravitreal triamcinolone) as well as standard laser treatment where appropriate.

The specific aims will be to test the following hypotheses:

- That intravitreal triamcinolone for diabetic macular oedema that persists or recurs

after laser treatment remains efficacious over five years

- That intravitreal triamcinolone for diabetic macular oedema that persists or recurs

after laser treatment retains a manageable and acceptable safety profile over five years

more trials >>


Page last updated: 2007-06-01

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