Oral Sarecycline for Treatment of Papulopustular Rosacea: Results of a Pilot Study of Effectiveness and Safety

April 2021 | Volume 20 | Issue 4 | Original Article | 426 | Copyright © April 2021


Published online March 25, 2021

James Q. Rosso DOa, Zoe Diana Draelos MDb, Cheryl Effron MDc, Leon H. Kircik MDd

aJDR Dermatology Research/Thomas Dermatology, Las Vegas, NV
bDermatology Consulting Services, PLLC, High Point, NC
cCosmetic Dermatology of Orange County, Anaheim Hills, CA
dIcahn School of Medicine at Mount Sinai, NY; Indiana Medical Center, Indianapolis, IN; Physicians Skin Care, PLLC; DermResearch, PLLC, Louisville, KY

Abstract
Background: Cutaneous rosacea is a common inflammatory skin disorder that often presents with facial papulopustular lesions that are frequently bothersome to patients. Studies have shown oral sarecycline to be effective and safe for acne, with a low risk of side effects that are historically associated with other tetracycline-class drugs such as doxycycline and minocycline, in addition to offering a reduced risk of emergence of resistant bacteria due to its narrow-spectrum of antibiotic activity. Oral sarecycline is FDA-approved for the treatment of acne (2018).

Objective: A pilot study to evaluate the efficacy and safety of oral sarecycline in papulopustular rosacea.

Methods: A 12-week, prospective, parallel-group, investigator-blinded, controlled pilot study was completed evaluating once-daily sarecycline, using weight-based oral dosing as recommended for acne vs control (multivitamin tablet), for the treatment of moderate-to-severe papulopustular rosacea in adult subjects (n=102), aged ≥18 years. The primary efficacy endpoint was Investigator’s Global score (IGA; clear or almost clear) and percent reduction in inflammatory lesion count at week 12. Safety and tolerability assessments were performed as well.

Results: A total of 102 subjects were randomized; 97 completed the study. At week 12, IGA improvement was significantly greater for oral sarecycline when compared to the control (P<0.0001). Furthermore, absolute and percent reductions in inflammatory lesion counts were significantly greater in the sarecycline group for all weeks (4, 8, and 12) when compared to the control (P<0.001). Significant improvement in facial burning, erythema, and pruritus was reported in the sarecycline group, when compared to the control (P<0.05). No serious AEs were reported.

Conclusion: Sarecycline was effective, safe, and well-tolerated for treating papulopustular rosacea in adults with marked superiority in efficacy compared to subjects in the control group. With its narrow-spectrum activity, oral sarecycline may be a good option for the treatment of papulopustular rosacea. Additional studies are warranted to confirm the positive results of this pilot study.

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INTRODUCTION

Cutaneous rosacea is a common inflammatory facial dermatosis characterized visibly by persistent central facial erythema, episodic dilation of facial vasculature (flushing), and telangiectasias, with or without inflammatory (papulopustular) lesions and phymatous changes.1,2 Although prevalence rates vary among evaluated populations, and the disorder is reported to most commonly affect fair-skinned individuals, rosacea is an “equal opportunity disease” that can affect all races, colors, and creeds.3-5 Beyond the signs and symptoms of rosacea, the disorder may be stigmatizing, can adversely influence workplace behavior and contribution, and has been associated with psychosocial sequelae including, anxiety, depression, embarrassment, and loss of self-esteem.5 The presentation of patients with papulopustular rosacea is common in clinical practice, with flushing episodes and papulopustular lesions reported as the most bothersome manifestations of rosacea across all disease severities.6

Comprehensive management of rosacea requires the incorporation of multiple therapeutic approaches in order to fully address the signs and symptoms that are affecting any given patient with rosacea that we encounter in “real world” clinical practice.7,8 With regard to use of pharmacologic therapies, the major emphasis to date has been with topical and oral agents that effectively reduce papulopustular lesions.7,9,10 Among oral therapies, the second generation tetracycline agents, doxycycline and minocycline, have been the most commonly utilized for both acne and rosacea over the past several years, with greater emphasis in the literature on doxycycline for rosacea primarily due to approval by the United States (US) Food and Drug Administration (FDA) of a modified-release sub-antibiotic dose doxycycline capsule (40 mg daily) for papulopustular lesions of rosacea in adults.11-13 In 2018, the third generation oral tetracycline, sarecycline, was approved by the US FDA for treatment of acne vulgaris in patients 9 years of age and older.14 Reported potential advantages with sarecycline include a narrow spectrum of antibiotic activity with a lower risk of antibiotic selection pressure and emergence of resistant bacteria (including several gram-negative and anaerobic organisms that inhabit the gastrointestinal [GI] tract), and a low rate of adverse events historically associated with oral tetracyclines, such as photosensitivity, GI side effects, vertigo, and vaginal yeast infections.15-18

Due to the well-established role for oral tetracycline agents in rosacea treatment, and the desire to circumvent emergence of antibiotic resistant bacteria as much as possible, the authors have completed a pilot study evaluating the use of oral sarecycline in patients with rosacea. This article reviews the results of this study.

STUDY DESIGN

A prospective, parallel group, randomized, multicenter, investigator-blinded, clinical trial was designed with a target population of one hundred (100) adult subjects with moderate-to-severe papulopustular rosacea. Subjects were randomized to