[Double-blind study versus excipient of 0.75% metronidazole gel in the treatment of rosacea].
BACKGROUND
The proven value of tetracyclines and metronidazole administered orally in the treatment of the chronic and recurrent disease that is rosacea is tempered by the important undesirable effects observed in long-term therapy. The purpose of this study was to test the effectiveness of an 0.75 p. 100 metronidazole gel in the treatment of rosacea.


METHODS
The study involved two groups of patients: one received the metronidazole gel and the other the vehicle of the gel used as placebo. The multicentre randomized trial was conducted in the double-blind fashion by 18 private dermatologists working in the Paris region. Fifty one patients who, since more than 3 months, had been presenting with rosacea, defined as at least 4 papulopustules associated with erythema and/or telangiectasia, entered the trial. Topical treatments and systemic treatments which had shown some activity against rosacea had been interrupted for 15 days or 2 months respectively. The product (or the placebo) was applied a.m. and p.m. on the whole dry face. The patients were seen on days 0, 21 and 42. The evaluation was purely clinical, and the principal criterion of judgement was a change in the number of papulopustules between days 0 and 42.


RESULTS
The metronidazole gel reduced the number of papulopustules between day 0 and day 42, and this reduction was significantly greater than that observed with the excipient alone. The active product began to be effective during the third week and remained so during the next three weeks. Both the metronidazole gel and its excipient seemed to be poorly tolerated, with frequent complaints of dry skin, but in 5 women of the metronidazole group this dryness was alleviated by application of moisturizers.


CONCLUSIONS
This study has demonstrated that the 0.75 p. 100 metronidazole gel is effective in the treatment of the papulopustular component of rosacea.
Espagne
E
E
Groupe d'Essais Thérapeutiques en Pratique de Ville, Hôpital Henri Mondor, Créteil.
Guillaume
J C
JC
Archimbaud
A
A
Baspeyras
M
M
Boitier
F
F
Bussière
M
M
Chamberlin
J
J
Coin
A
A
Di Crescenzo
M C
MC
Dolivo
M
M
D000287:Administration, Topical; D000328:Adult; D004311:Double-Blind Method; D005079:Excipients; D005260:Female; D005782:Gels; D006801:Humans; D008297:Male; D008795:Metronidazole / Q000008:administration & dosage / Q000627:therapeutic use*; D010919:Placebos; D012393:Rosacea / Q000188:drug therapy*
D005079:Excipients; D005782:Gels; D010919:Placebos; D008795:Metronidazole
Etude en double insu contre excipient du métronidazole gel à 0.75 p. 100 dans le traitement de la rosacée.