[Rilmenidine in rosacea: a double-blind study versus placebo]. 1997

E Grosshans, and C Michel, and B Arcade, and B Cribier
Clinique Dermatologique des Hôpitaux Universitaires de Strasbourg.

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.

UI MeSH Term Description Entries
D008297 Male Males
D008875 Middle Aged An adult aged 45 - 64 years. Middle Age
D010080 Oxazoles Five-membered heterocyclic ring structures containing an oxygen in the 1-position and a nitrogen in the 3-position, in distinction from ISOXAZOLES where they are at the 1,2 positions. Oxazole,1,3-Oxazolium-5-Oxides,Munchnones,1,3 Oxazolium 5 Oxides
D010919 Placebos Any dummy medication or treatment. Although placebos originally were medicinal preparations having no specific pharmacological activity against a targeted condition, the concept has been extended to include treatments or procedures, especially those administered to control groups in clinical trials in order to provide baseline measurements for the experimental protocol. Sham Treatment
D004311 Double-Blind Method A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment. Double-Masked Study,Double-Blind Study,Double-Masked Method,Double Blind Method,Double Blind Study,Double Masked Method,Double Masked Study,Double-Blind Methods,Double-Blind Studies,Double-Masked Methods,Double-Masked Studies,Method, Double-Blind,Method, Double-Masked,Methods, Double-Blind,Methods, Double-Masked,Studies, Double-Blind,Studies, Double-Masked,Study, Double-Blind,Study, Double-Masked
D004361 Drug Tolerance Progressive diminution of the susceptibility of a human or animal to the effects of a drug, resulting from its continued administration. It should be differentiated from DRUG RESISTANCE wherein an organism, disease, or tissue fails to respond to the intended effectiveness of a chemical or drug. It should also be differentiated from MAXIMUM TOLERATED DOSE and NO-OBSERVED-ADVERSE-EFFECT LEVEL. Drug Tolerances,Tolerance, Drug,Tolerances, Drug
D005260 Female Females
D005483 Flushing A transient reddening of the face that may be due to fever, certain drugs, exertion, or stress. Flushings
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000077769 Rilmenidine Oxazole derivative that acts as an agonist for ALPHA-2 ADRENERGIC RECEPTORS and IMIDAZOLINE RECEPTORS. It is used in the treatment of HYPERTENSION. 2-(N-(Dicyclopropylmethyl)amino)oxazoline,2-(N-(Dicyclopropylmethyl)amino)oxazoline Phosphate Salt,Hyperium,Oxaminozoline,Rilmenidine Phosphate,S 3341,S-3341,S-3341-3,S3341,S 3341 3,S33413

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