MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Winkelman: Rosacea is a common dermatologic facial disorder estimated to affect 16 million Americans. Rosacea is a chronic condition of the central face, including the nose, chin, cheeks and forehead, and is often characterized by flare-ups and remissions. While the cause of rosacea is unknown and there is no cure, its signs and symptoms can become markedly worse in the absence of treatment. Rosacea can be managed with topical and oral medications, and physicians often resort to using these medications in combination for more severe or resistant cases. Doxycycline 40 mg modified release (MR) and metronidazole 1% gel are FDA-approved oral and topical therapies, respectively, indicated to treat the papules and pustules of rosacea. We conducted a phase 2 study to assess the relapse rate, efficacy, and safety of doxycycline 40 mg MR compared to placebo after an initial 12-week once-daily combination regimen of doxycycline 40 mg MR and metronidazole 1% gel in subjects with moderate to severe disease.
Of the 235 subjects enrolled in the study, 71% were women, 94% were white, and 75% had Fitzpatrick skin type I, II or III. The mean age was 47.4 years. The percentage of subjects who achieved a success score of 0 (clear) or 1 (near clear) improved from 0% at baseline to 51% at week 12. Clinician’s erythema assessment scores, inflammatory lesion counts, and quality of life scores also improved. Most subjects reported no or mild scaling, stinging/burning, and dryness. Five adverse events were reported that were considered probably or definitely related to treatment: fungal infection, vulvovaginal mycotic infection, pain in extremity, erythema, and skin exfoliation.
MedicalResearch.com: What should clinicians and patients take away from your report?
Dr. Winkelman: A once-daily combination regimen of doxycycline 40 mg MR and metronidazole 1% gel was observed to be efficacious, safe, and tolerable, and had a positive effect on quality of life in subjects with moderate to severe rosacea.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Dr. Winkelman: Future research should include long-term approaches to managing signs and symptoms of rosacea. In addition, further examination of the pathophysiology of rosacea and the mechanism of action of factors that trigger the onset of signs and symptoms and exacerbate the condition will be vital in treating this chronic skin condition.
Berlin J and Winkelman W. Efficacy and tolerability of oral doxycycline 40 mg modified released with topical metronidazole 1% gel in moderate to severe rosacea. Poster presented at 73rd Annual Meeting American Academy of Dermatology; March 20-24, 2015; San Francisco, CA.
MedicalResearch.com Interview with: Warren J. Winkelman, MD, MBA, PhD, FRCPC, FAAD (2015). Rosacea Improved With Modified Release Doxycycline 40 mg Plus Topical Metronidazole MedicalResearch.com