[Rilmenidine in rosacea: a double-blind study versus placebo].
BACKGROUND
The usual treatments of rosacea (cyclines and metronidazole) are mainly effective on reducing the number of papules and pustules. Clonidine only was employed in order to treat flushes observed in rosacea. Rilmenidine is a central hypotensive drug which acts more specifically than clonidine on imidazoline receptors and which has no sedative side effects. The purpose of this study was to evaluate the efficacy of rilmenidine 1 mg/d in the treatment of rosacea.


METHODS
A total of 41 patients suffering from typical rosacea were selected in this randomised double blind study rilmenidine versus placebo. The study comprised an 1-month observation period without treatment followed by 3 months of treatment. The major assessment criteria was the proportion of responders at the end of the treatment period. Responders were defined as patients showing a decrease of more than 50 p. 100 in the count of papules and pustules. Minor criterias were the variation of the number of flushes, self-evaluated by the patient and the variation of the redness of the face, noted by the investigator on a scale from 0 to 5.


RESULTS
Fifteen patients treated by rilmenidine (R) and 19 patients receiving the placebo (P) were evaluated. The proportion of responders was 69.2 p. 100 in group R and 57.1 p. 100 in group P (p = 0.69). The variations of the number of papules and pustules and of the redness of the face were not significantly different in the two groups. The decrease in the number of flushes was higher in group R (around -13) than in group P (around -5), but the difference was not really significant (p = 0.076). Arterial pressure decreased in 3 patients in group R and in 2 patients in group P. Minor side effects were noted in a similar proportion of patients in the two groups.


CONCLUSIONS
Rilmenidine is not efficient in reducing the number of papules and pustules but could decrease the number of flushes. Nevertheless, many patients were lost for follow-up and because of a major placebo effect, the conclusions of this study are not strong enough. Another study including more patients and using evaluation criteria based on the vascular components of rosacea could perhaps confirm this hypothesis.
Grosshans
E
E
Clinique Dermatologique des Hôpitaux Universitaires de Strasbourg.
Michel
C
C
Arcade
B
B
Cribier
B
B
D000316:Adrenergic alpha-Agonists / Q000627:therapeutic use*; D000328:Adult; D004311:Double-Blind Method; D004361:Drug Tolerance; D005260:Female; D005483:Flushing / Q000517:prevention & control; D006801:Humans; D008297:Male; D008875:Middle Aged; D010080:Oxazoles / Q000627:therapeutic use*; D010919:Placebos; D000077769:Rilmenidine; D012393:Rosacea / Q000188:drug therapy*; D016896:Treatment Outcome
D000316:Adrenergic alpha-Agonists; D010080:Oxazoles; D010919:Placebos; D000077769:Rilmenidine