Acne rosacea: An open comparative trial of azithromycin versus oxytetracycline therapy: Study of 50 patients
Bakar Bouadjar, PhD, CHU of BEO, Algiers, Algeria
Background: Azithromycin has been used successfully to treat acne vulgaris and its use for the treatment of rosacea has been evaluated only once in an open study.
Objectives: The goal of the study was to compare the efficacy and safety of oral oxytetracycline and azithromycin in the treatment of patients with acne rosacea.
Patients and methods: We proposed an open comparative study of azithromycin versus oxytetracycline in 50 adults with acne rosacea. Inclusion criteria were as follows: (1) patients with rosacea characterized by persistent symmetrical erythema affecting the cheeks and with at least 10 inflammatory papules or pustules; (2) patients with no treatment for rosacea 1 month prior to starting azithromycin or oxytetracycline. This treatment included topical metronidazole, topical corticosteroids or antibiotics and systemic corticosteroids or antibiotics. Exclusion criteria were as follows: Patients with significant concomitant dermatologic disorders, a presence of other conditions that could affect study results. A single dose of 250 mg of azithromycin was taken 3 times a week during 4 weeks in one group of 25 patients and 250 mg of oxytetracycline was taken 4 times a day during 4 weeks in the second group of 25 patients. The clinical response and side effects was evaluated once a week. The investigator performed a count of inflammatory lesions (papules and pustules) at baseline (week 0) and at weeks 1, 2, 3, and 4. Signs and symptoms (erythema, telangiectasia, dryness, itching, burning) will be assessed by means of a 4-point scale. Throughout the study, the same investigator will make all assessments. Patients will assess their own disease severity: signs and symptoms at week 0, 1, 2, 3, 4. Statistical analysis was done by means of chi-square tests, paired tests, and analysis of variance.
Results: Good to excellent improvement in the two groups was seen. There was no significant difference in the two groups in terms of reduction of the number of inflammatory lesions and in the reduction of symptoms. Eight patients in the oxytetracycline group showed secondary effects (ie, hyperpigmentation, nausea, and abdominal pain).
Conclusion: Our results show that azithromycin is a safe and effective treatment in acne rosacea with few side effects and good compliance and suggest the need for further investigation with a clinical trial that will compare the long-termefficacy and tolerability.
Author disclosure: Nothing disclosed at press time. Commercial support: None.
Poster Discussion Session P139, American Academy of Dermatology, 64th Annual Meeting, March 3-7 2006, San Francisco.
Supplement to Journal of The American Academy of Dermatology, March 2006, Volume 54, Number 3.
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