Medscape Article on MetroLotion and MetroCream

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Skin & Allergy News

New Cream, Lotion Formulations of Metronidazole

Betsy Bates, Los Angeles Bureau

[skin & Allergy News 31(4):15, 2000. © 2000 International Medical

News Group.]

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SAN FRANCISCO - cea patients with dry skin may benefit most from

cream and lotion formulations of metronidazole, based on study

results presented at the annual meeting of the American Academy of

Dermatology.

A lotion form of metronidazole 0.75% was released last summer by

Galderma Laboratories, which unveiled its open-label and randomized,

double-blind, placebo-controlled studies of cream and lotion

formulations of the agent, originally introduced as a gel.

In all three studies, which involved a total of more than 2,500

patients, symptoms of dry, irritated skin were relieved by the lotion

or cream formulations.

Dr. J. Leyden, professor of dermatology at the University of

Pennsylvania in Philadelphia, reported on a multicenter, vehicle-

controlled study of 128 patients randomized to receive 0.75%

metronidazole topical cream or a vehicle cream for 12 weeks.

The patients, who suffered from moderate to severe rosacea, applied

the creams twice daily to their faces.

The average number of inflammatory lesions was reduced from 13 to 4

(a 69% change) in patients applying metronidazole cream, compared

with a drop from 12 to 8 (a 33% change) in patients receiving placebo.

Blinded investigators reported that 64% of patients receiving

metronidazole cream ended the study with absent or mild residual

rosacea, compared with 39% in the vehicle group.

Improvement was even greater among patients with dry skin at

baseline, 76% of whom were cleared or markedly improved after 12

weeks of using metronidazole cream, compared with 39% of patients on

placebo.

No statistically significant differences were seen in erythema or

telangiectasia between the two groups; however, there was a trend to

significance in reduction of these signs among patients with dry skin

who were in the active-treatment group, he commented.

There were no systemic side effects or skin-related adverse events of

note reported in either arm of the study.

A European study led by Dr. Gerard Guillet of Galderma's research and

development division in Brest, France, concluded that metronidazole

0.75% gel and lotion were equally effective in treating moderate to

severe rosacea in 114 patients.

Among 57 patients who used the lotion, the inflammatory lesion count

declined 71%, compared with 63% in 57 patients who used the gel, a

statistically insignificant difference.

A significant difference emerged in terms of dryness scores, which

were lower in the lotion group than in the gel group at weeks 8 and

12.

A third of the patients who were using the gel reported skin

tightness, compared with the 11.5% of patients who were using the

lotion.

Galderma's open-label, preintroductory evaluation of metronidazole

cream found that 78% of 2,301 patients achieved an excellent response

(clearing or a marked improvement) after using the cream for 6 weeks.

Patients in this trial reflected " real-world dermatology, " since the

cream was sent to many practicing physicians who could simultaneously

prescribe other drugs such as tetracycline, said Baker,

project manager for phase IV clinical trials at Galderma's research

center in Princeton, N.J.

Although it was not a controlled trial, the results were noteworthy

in terms of the magnitude of benefit reported by patients with dry

skin, who constituted 89% of the study group.

In that group, severe skin dryness and irritation declined 85% with

use of the cream.