Re: Medline Study on Canadian Metronidazole 1% Cream

[Guest guest]

Matija, I heard (from a Canadian pharmacist) that Mexoryl hasn't been

approved for use in the US because it cannot prove its claim that, as

a chemical sunscreen, it does not break down in the presence of

sunlight (just like the rest of the chemical sunscreens). Mexoryl

does make the claim, but I don't know if that's why it hasn't been

approved here.

It's great that you found new rosacea research to share. Regarding

the abstract, I think there's something sneaky going on: the placebo

contained the sunscreen. So, what was tested was just metronidazole

cream, *not* the metronidazole/sunscreen combination.

Even more suspicious, this would be the first study that shows a

response to topical antibiotics for moderate and severe rosacea, and

for features such as telangiectasias (spiders). That brings into

question how they are defining rosacea, how they define " significant

improvement, " how they are defining telangiectasia and/or how

carefully the study was conducted and supervised.

I don't know anything about the Journal of Cutaneous Medicine and

Surgery, but the abstract doesn't convince at all. It reads

like " research " designed and conducted by the pharmaceutical company

using physicians in private practice, which many regard as a

marketing tool rather than a contribution to clinical science.

Marjorie

Marjorie Lazoff, MD

-- In rosacea-support@y..., " ruizdelvizo " wrote:

> 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