What More Can We Learn About Acne and Rosacea? Just Keep Reading, Questioning, and Searching for Clinical Relevance Beyond the Limitations of Clinical Trials
June 2013 | Volume 12 | Issue 6 | Editorials | 609 | Copyright © 2013
James Q. Del Rosso DO FAOCD
No abstract available
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As acne vulgaris (AV) and rosacea are commonly encountered in clinical practice, dermatologists manage patients by incorporating what they learned upfront during training, and later from respected educators, from reading the literature, and from what they have observed and experienced. Nevertheless, it is important to be open to new concepts about pathophysiology that may stimulate us to adjust our therapeutic approach and to critically evaluate more current research on therapeutic options and management. At each step along the journey, I encourage my colleagues to not accept new information as absolute fact, but to update our understanding of chronic diseases like acne and rosacea in a thoughtful manner and to adjust our approaches to management with a watchful and critical eye. In this era where the concept of evidence-based medicine is inexorably shoved upon us by academicians and education specialists in “ivory towers”, we must recognize that even the most well-designed studies report outcomes that later on do not match with “real world” experience. Disappointing therapeutic outcomes or unforeseen adverse events emerge in the clinic setting with more widespread use. One reason for this is the large jump that is made from the restricted population of subjects enrolled in clinical trials to “real world practice” where there is a larger volume of patients including “all comers” without exclusions. The restrictions imparted within clinical trials include the limitations of study design with inclusion and exclusion criteria, variability in grading outcomes among different investigators, and differences in assessment parameters (ie, severity ratings, grading of improvement, and study endpoints). Well-designed clinical studies undoubtedly provide very valuable and relevant information, and we need more of these to help us answer some important questions in areas where we have little or no good data. However, with “holes” in the evidence that are based on the inherent limitations of studies, it is ultimately up to the clinician to blend and extrapolate from both research results and their own clinical experience in order to optimize therapeutic results. In the end, the treatment of a patient is always our “best educated guess” coordinated with the medical and psychosocial needs of the individual patient.
This JDD issue, in my mind, is a “hall of fame” special topics collection of articles, especially the group covering AV.
The article by Zanglein et al discusses overall favorable results achieved with using a “full court press” for moderate to severe facial AV, incorporating once daily use of three products: a benzoyl peroxide (BP) 6% cleanser (cloth) previously shown to be efficacious and to reduce Propionibacterium acnes, topical clindamycin phosphate 1.2%-tretinoin 0.025% gel, and weight-based oral minocycline therapy (1 mg/kg/day extended-release tablet).1,2 Eichenfield et al report on study outcomes in preadolescent patients with facial AV (age range, 9 to 11 years) treated with adapalene 0.1%-BP 2.5% gel once daily, which led to recent approval by the Food and Drug Administration (FDA) in this age group. This is significant as there is a conspicuous absence of FDA-approved therapies for AV in patients <12 years of age. The four-decade history of topical tretinoin, the first FDA-approved topical retinoid, is reviewed by Baldwin, who walks us through the journey completed by this major advance in dermatology. The article discusses modes of action and its therapeutic “career” using different vehicle formulations. Clinical studies evaluating truncal AV are very limited. Hence, the article by Kimball et al is important to clinicians with outcomes reported with the oral contraceptive drospirenone/ethinyl estradiol for truncal AV in women. In this study, favorable results were noted in lesion reductions and by investigator global assessment.