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Medline Study on Canadian Metronidazole 1% Cream

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Hi,

I found this recent article on a Canadian Metronidazole 1% px cream

that has spf 15 due to Mexoryl SX -- a chemical sunscreen not

approved for use in the US. I don't know the name of this product,

but I assume it's widely available in Canada.

Take care,

Matija

Randomized Placebo-controlled Trial of Metronidazole 1% Cream with

Sunscreen SPF 15 in Treatment of cea [epub ahead of print]

[Record Supplied By Publisher]

J Cutan Med Surg 2002 May 13; pS1203-4754

Tan JK; Girard C; Krol A; Murray HE; Papp KA; Poulin Y; Chin DA;

Jeandupeux D

Windsor, Ontario, Canada.

Background: cea is a photoaggravated dermatosis responsive to

treatment with topical and oral antibiotics. A formulation combining

metronidazole 1% cream with sunscreen SPF 15 was developed for the

treatment of rosacea. Objective: The objective of this study was to

determine the safety and efficacy of a formulation combining

metronidazole 1% cream with sunscreen SPF 15 in the treatment of

moderate to severe rosacea. Methods: One hundred and twenty patients

with moderate to severe rosacea were enrolled for a randomized,

placebo-controlled (vehicle containing sunscreen with SPF 15), double-

blind study. Study cream was applied twice daily to the entire face

over a 12-week period. Results: Treatment with metronidazole 1% cream

with sunscreen SPF 15 resulted in significant improvement (p <0.05)

in inflammatory lesion count, erythema and telangiectasiae scores,

and investigator and patient global assessment scores compared with

baseline and placebo. Adverse reactions related to study medication

were typically mild, occurred at the site of application, and were

reversible. There was no difference between the safety profiles of

metronidazole 1% cream with sunscreen SPF 15 and placebo.

Conclusions: The combined topical formulation of metronidazole 1%

cream with sunscreen SPF 15 was an effective, well-tolerated topical

agent for the treatment of moderate to severe rosacea. Antecedents:

L'acne rosacee est une photodermatose qui repond aux traitements a

base d'antibiotiques topiques et oraux. Une formule combinant la

creme de metronidazole a 1% avec un ecran solaire FPS 15 a ete mise

au point pour le traitement de 1'acne rosacee. Objectif: L'objectif

de l'etude est d'evaluer l'innocuite et l'efficacite d'une formule

combinant la creme de metronidazole a 1% a un ecran solaire FPS 15

dans le traitement des cas moderes a graves d'acne rosacee. Methodes:

Cent vingt patients atteints d'acne rosacee moderee a grave ont

participe a une etude sur echantillon aleatoire, controlee (placebo

contenant un ecran solaire FPS 15) et a double insu. La creme a ete

appliquee a tout le visage, deux fois par jour, durant 12 semaines.

Resultats: Le traitement a base de creme de metronidazole a 1% avec

un ecran solaire FPS 15 a produit une nette amelioration (p <0.05)

quant aux lesions inflammatoires, a l'erytheme et a la

telangiectasies. Egalement, 1'evaluation generale des chercheurs et

des patients etait meilleure que celle du groupe placebo ou du groupe

de reference. Les effets indesirables dus au medicament administre

durant 1'etude etaient legers, localises et reversibles. Il n'y avait

aucune difference entre le profil d'innocuite de la creme de

metronidazole a 1% avec un ecran solaire FPS 15 et le placebo.

Conclusions: La formule combinant la creme de metronidazole a 1% avec

un ecran solaire FPS 15 represente un agent topique efficace et bien

tolere dans le traitement des cas moderes a graves d'acne rosacee.

Language: English

MEDLINE Indexing Date: 200200

Publication Type: ;

Publication Type: JOURNAL ARTICLE

PreMedline Identifier: 0012001006

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