Effectiveness and Safety of Once-Daily Doxycycline Capsules as Monotherapy in Patients With Rosacea: An Analysis by Fitzpatrick Skin Type
October 2012 | Volume 11 | Issue 10 | Original Article | 1219 | Copyright © October 2012
Rosacea is often under-recognized or misdiagnosed in patients with skin of color (Fitzpatrick Skin Types [FST] IV-VI). Subtle clinical features and a low index of suspicion likely contribute to less frequent diagnosis in this population. Clinical trials of therapeutic agents for rosacea generally include few patients from nonwhite racial/ethnic groups and therefore, potential differences in treatment outcomes have not been previously studied. The objective of this prospective analysis was to fill the gap in knowledge of the effectiveness and safety of treatment for rosacea in patients with skin of color. We analyzed data from 826 adults aged ≥18 years with papulopustular (subtype 2) rosacea (663 FST I-III; 163 FST IV-VI). All patients received doxycycline 40 mg capsules (30 mg immediate release and 10 mg delayed release beads) once daily as monotherapy for 12 weeks in this open-label, multicenter, community-based study. Investigators assessed disease severity with the Investigator's Global Assessment (IGA) and erythema with the Clinician's Erythema Assessment (CEA). Significant improvement in disease severity and erythema was obtained in patients with FST I-III and IV-VI at week 12 (P<.001). Treatment success, defined as an IGA score of 0 or 1 was achieved in 74.6% and 74.3% of patients with FST I-III and IV-VI, respectively. Approximately 12% of patients experienced adverse events with no difference between the two skin type groups. The results of this prospective subgroup analysis of data from a large community-based trial suggest that doxycycline produced similar effectiveness and safety profiles in patients with FST I-III and IV-VI. J Drugs Dermatol.
Rosacea is a chronic inflammatory facial dermatosis that is typically characterized by a pattern of unpredictable exacerbations and remissions. The highest incidence of rosacea occurs in people of Celtic and Northern European origin; however, the disease can affect patients of all racial and ethnic origins across the full range of Fitzpatrick Skin Types (FST).1-7
Many treatments for rosacea have been evaluated in clinical trials. A recently published meta-analysis included data from more than 6633 patients enrolled in 58 randomized trials, 28 of which were conducted since the year 2000.8 Despite this extensive body of evidence from clinical trials, there is a gap in knowledge with respect to the comparative effectiveness of treatments in patients with different FST. It has been suggested that rosacea often goes unrecognized or is misdiagnosed in patients with skin of color, and that is because clinical trials of rosacea therapies generally include small numbers of patients with skin of color, it is difficult to draw conclusions on the comparative effectiveness or safety of therapies in patients of different racial origins.3
Oral tetracyclines are the mainstay of systemic treatment for rosacea,5 and among tetracyclines only doxycycline 40 mg capsules (30 mg immediate release and 10 mg delayed release beads; Oracea®, Galderma Laboratories, L.P., Fort Worth, TX) are approved for the treatment of rosacea. This formulation contains a low dose of doxycycline that produces plasma levels below that required for an antimicrobial effect, yet causes a reduction in inflammation in papulopustular rosacea as demonstrated through decreased lesion counts. For these reasons, this doxycycline formulation is better tolerated and less likely to give rise to antibiotic resistance than antimicrobial doses of the drug.9 The efficacy and safety of this doxycycline formulation have been evaluated in large randomized clinical trials.10,11 The effectiveness also has recently been evaluated alone as monotherapy and in combination with ongoing topical therapies in the largest community-based trial of treatment for rosacea (Oracea® for Rosacea: a Community-based Assessment [ORCA]).12,13 This trial included a broad cross section of patients with diverse skin types. The objective of this prospective subgroup analysis was to evaluate the effectiveness of doxycycline by FST I-III and FST IV-VI.