Short-Term Combination Therapy and Long-Term Relapse Prevention in the Treatment of Severe Acne Vulgaris
February 2012 | Volume 11 | Issue 2 | Original Article | 174 | Copyright © February 2012
Jerry Tan MD,a Linda Stein Gold MD,b Joel Schlessinger MD,c Robert Brodell MD,d Terry Jones MD,e Alma Cruz,f Nabil Kerrouche MSc,g Michael Jarratt MDh
aWindsor Clinical Research Inc., Windsor, Ontario, Canada bHenry Ford Health Systems, Detroit, MI cAdvanced Skin Research Center, Omaha, NE dBrodell Medical Inc., Warren, OH eJ&S Studies, Inc., College Station, TX fCarolina Shopping Court (Grupo Dermatologico de Carolina), Carolina, Puerto Rico gGalderma R&D, Sophia-Antipolis, France hDermResearch, Inc., Austin, TX
Abstract
Few long-term treatment regimens for severe acne vulgaris have been investigated in clinical trials. Data were combined from two consecutive, randomized, double-blind, controlled studies to evaluate the efficacy, safety and subject satisfaction of four nine-month regimens in severe acne vulgaris treatment. Subjects were first randomized to receive doxycycline (DCN) and adapalene 0.1% - benzoyl peroxide 2.5% (A/BPO) or vehicle once daily for 12 weeks. Subjects who had at least 50% global improvement were subsequently randomized to receive A/BPO or its vehicle once daily for 24 weeks. Over nine months, there were four regimens: A/BPO and DCN followed by A/BPO, vehicle and DCN followed by A/BPO, A/BPO and DCN followed by vehicle, and vehicle and DCN followed by vehicle. Among the four regimens, A/BPO and DCN followed by A/BPO led to the highest percentage of subjects rated "clear" or "almost clear" (50.0% vs. 40.4%, 26.2% and 25.0%, respectively), biggest reduction in total lesion counts (76% vs. 70%, 51% and 47%, respectively) and greatest subject satisfaction (85.0% vs. 75.5%, 63.3% and 52.4%, respectively) at week 36. It provided a faster onset of action compared to groups started with vehicle and DCN (P<.05 at week 2). Subjects receiving A/BPO and DCN followed by vehicle experienced deterioration once the active treatment was discontinued. All regimens were safe and well-tolerated. In conclusion, efficacious initial therapy and long-term treatment are both important. An initial combination therapy with adapalene-BPO and DCN followed by longer-term adapalene-BPO treatment is an efficacious and satisfactory new regimen for severe acne subjects.
J Drugs Dermatol. 2012;11(2):174-180.
INTRODUCTION
Acne vulgaris is a chronic inflammatory disease, which if left untreated, could negatively impact quality of life and confer permanent scarring.1-2 Accordingly, optimal management would address both rapid disease control in the short-term with long-term prevention of relapse.3
In view of the multi-factorial pathogenesis of acne, combination
therapy using agents with complementary modes of action is a rational treatment approach for all but the most severe presentations.4-7 The fixed-dose combination of adapalene 0.1% and benzoyl peroxide 2.5% (Epiduo®, Galderma S.A.; hereafter A/BPO) has previously been shown to be significantly more efficacious with more rapid onset of effect compared to its components in randomized, double-blind, controlled trials in moderate acne vulgaris.8-10 Its long-term safety has also been demonstrated in a 12-month study, in which A/BPO was used daily.11 Furthermore, recent analyses showed that A/BPO acts synergistically and provides greater level of efficacy for subjects
with higher acne lesion counts.12,13
For all but the most severe cases of acne, the Global Alliance to Improve Outcomes in Acne recommends early initiation of
