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

J Am Acad Dermatol. 2005 Nov;53(5):791-7. doi: 10.1016/j.jaad.2005.04.069. Epub 2005 Sep 15.

Abstract

Background: Subantimicrobial doses of doxycycline may improve outcomes in rosacea when combined with topical metronidazole and used as maintenance monotherapy.

Objective: The purpose of this study was to evaluate the safety and efficacy of doxycycline hyclate 20 mg (subantimicrobial dose doxycycline) administered twice daily as an adjunct to metronidazole 0.75% topical lotion in the treatment of rosacea.

Methods: Patients received subantimicrobial doses of doxycycline twice daily plus metronidazole (n = 20) or placebo plus metronidazole (n = 20) for 12 weeks. Subantimicrobial-dose doxycycline or placebo monotherapy continued for 4 weeks. The primary efficacy measure was change from baseline in total inflammatory lesions at weeks 2 and 16.

Results: Total inflammatory lesions were reduced significantly (P =.048) by week 4 and by all subsequent visits in the subantimicrobial-dose doxycycline/metronidazole group compared with placebo/metronidazole. Changes from baseline increased over time and were maintained during subantimicrobial-dose doxycycline monotherapy.

Conclusion: Adjunctive use of subantimicrobial dose doxycycline significantly reduced the clinical signs of rosacea compared with metronidazole alone and may be useful maintenance monotherapy.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Topical
  • Adult
  • Anti-Infective Agents / administration & dosage*
  • Double-Blind Method
  • Doxycycline / administration & dosage
  • Doxycycline / analogs & derivatives*
  • Drug Therapy, Combination
  • Female
  • Humans
  • Male
  • Metronidazole / administration & dosage*
  • Rosacea / drug therapy*
  • Tablets

Substances

  • Anti-Infective Agents
  • Tablets
  • Metronidazole
  • Doxycycline