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 - 21/08/11

Doi : 10.1016/j.jaad.2005.04.069

Jorge Sanchez, MD ^a,^⁎ , Aida Lugo Somolinos, MD ^a, Pablo I. Almodóvar, MD ^a, Guy Webster, MD ^b, Mark Bradshaw, PhD ^c, Christopher Powala, BS ^d
^a From the University of Puerto Rico, Rio Piedras
^b Jefferson Medical College, Philadelphia
^c Covance, Inc, Princeton
^d CollaGenex Pharmaceuticals, Inc, Newton

Reprint requests: Jorge Sanchez, MD, Department of Dermatology, Puerto Rico Medical Center, Medical Sciences Campus, Pharmacy Building, 5th Floor, Rio Piedras, PR 00935.

Rio Piedras, Puerto Rico; Philadelphia, Pennsylvania; Princeton, New Jersey; and Newton, Pennsylvania

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.

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