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.

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.

• Authors: Jorge Sanchez, Aida Lugo Somolinos, Pablo I Almodóvar, Guy Webster, Mark Bradshaw, Christopher Powala
• Journal: Journal of the American Academy of Dermatology (J Am Acad Dermatol) Vol. 53 Issue 5 Pg. 791-7 (Nov 2005) ISSN: 1097-6787 [Electronic] United States
• PMID: 16243127 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-Infective Agents
• Tablets
• Metronidazole
• Doxycycline

Topics

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