Journal of Drugs in Dermatology - A randomized, double-blind, placebo-controlled trial of the combined effect of doxycycline hyclate 20-mg tablets and metronidazole 0.75% topical lotion in the…
A Randomized, Double-Blind, Placebo-Controlled Trial of the Combined Effect of Doxycycline Hyclate 20-mg Tablets and Metronidazole 0.75% Topical Lotion in the Treatment of Rosacea
Sanchez J, et al. Journal of the American Academy of Dermatology. 2005;53:791-797.
Summary
Related Results
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The authors present a randomized, double-blind, placebo-controlled trial to evaluate the efficacy of metronidazole 0.75% lotion as monotherapy compared with metronidazole lotion and doxycycline hyclate 20-mg tablets in the treatment of rosacea. Forty patients were enrolled and distributed in a 1:1 ratio to 1 of 2 treatment arms. One group received metronidazole 0.75% lotion twice daily with doxycycline hyclate 20-mg tablets twice daily (combination treatment group) for 12 weeks. After 12 weeks, doxycycline hyclate 20-mg tablets alone were continued twice daily for another 4 weeks. The other group received metronidazole 0.75% lotion twice daily with placebo tablets twice daily (monotherapy group) for 12 weeks with continuation of placebo tablets alone twice daily for another 4 weeks. There were no statistically significant differences in demographic characteristics between the 2 groups at baseline. Patients were evaluated at baseline and at weeks 4, 8, 12, and 16. Photographs of the face were taken at baseline and at weeks 12 and 16. At each assessment, the number and types of lesions were noted in addition to recording the Clinician’s Global Severity Score and the Clinician’s Global Erythema Assessment. The primary outcome was the total inflammatory lesion count at week 12 and week 16 in comparison to the baseline lesion count. An intent-to-treat analysis was performed. Patients in the combination treatment group showed a statistically significant decrease in total inflammatory lesion count at week 12 in comparison to the monotherapy group. This decrease was maintained after 4 weeks of doxycycline alone, being statistically significant at week 16. Total inflammatory lesion counts were also significantly decreased at week 4 and at week 8 in the combination treatment group. The difference in the Clinician’s Global Severity Score was statistically significant for the combination treatment group at week 12. Treatment in both groups was-well tolerated with no occurrence of serious adverse events.
Comment
The authors present a randomized, double-blind, placebo-controlled trial to evaluate the efficacy of metronidazole 0.75% lotion as monotherapy compared with metronidazole lotion and doxycycline hyclate 20-mg tablets in the treatment of rosacea. Twenty milligrams of doxycycline is a subantimicrobial dose that has been shown neither to decrease microflora nor to cause development of resistant organisms. Patients in the combination treatment group had a statistically significant decrease in total inflammatory lesion counts at weeks 12 and 16 in comparison to the monotherapy group. In addition, this decrease was maintained when doxycycline was used as monotherapy. One limitation of this study is the small number of patients enrolled. In addition, while the combination treatment group had a greater response to therapy, it is unclear from the analysis presented in this study if the monotherapy group also achieved a statistically significant decrease in lesion count compared to baseline.
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