Management of Truncal Acne With Oral Sarecycline: Pooled Results from Two Phase-3 Clinical Trials

June 2021 | Volume 20 | Issue 6 | Original Article | 634 | Copyright © June 2021


Published online May 14, 2021

James Q. Del Rosso DO,a Linda Stein Gold MD,b Hilary Baldwin MD,c Julie C. Harper MD,d Joshua Zeichner MD, e Sabine Obagi,f Emmy Graber MD MBA,g Xochitl Jimenez MD,h Francisco Hernandez Vicente,i Ayman Grada MD MHAj

aJDR Dermatology Research/Thomas Dermatology, Las Vegas, NV
bDermatology Clinical Research, Henry Ford Health System, Detroit, MI
cDepartment of Dermatology, Acne Treatment & Research Center, Morristown, NJ
dDermatology and Skin Care Center of Birmingham, Birmingham, AL
eMount Sinai Hospital, New York, NY
fBoston University School of Medicine, Boston, MA
gDermatology Institute of Boston, Boston, MA; Northeastern University, Boston, MA
hMedical Affairs, Almirall LLC., Exton, PA IGlobal Clinical Statistics, Almirall SA., Barcelona, Spain
jR&D and Medical Affairs, Almirall LLC., Exton, PA

Abstract
Background: Acne vulgaris is a common skin disease that affects the face, chest, and back. While truncal acne is present in at least 50% of patients, clinical studies have focused predominantly on facial acne.1,2 Few treatments to date have been evaluated for truncal acne. Sarecycline is a narrow-spectrum, third-generation, tetracycline-class oral drug approved for the treatment of acne. Pivotal phase-3 studies show that sarecycline is safe, well-tolerated, and effective treatment for moderate to severe acne vulgaris.
Method: Pooled analysis was performed for truncal acne results with sarecycline from the two phase 3 studies. Investigator Global Assessment (IGA) success was evaluated at weeks 3, 6, 9, and 12.
Results: Chest IGA success rate were significantly greater with sarecycline versus placebo at weeks 3 (11.84% vs 7.71%, respectively; P=0.0192), 6 (18.81% vs 14.03%, respectively; P=0.0390), and 12 (33.42% vs 20.77%, respectively; P<0.0001). Back IGA success rate was also significantly greater with sarecycline versus placebo group at weeks 3 (12.13% vs 7.04%, respectively; P=0.0023), 6 (18.42% vs 14.34%, respectively; P=0.0412), 9 (29.05% vs 19.88%, respectively; P=0.0004) and 12 (33.07% vs 21.91%, respectively; P<0.0001)
Conclusion: Sarecycline efficacy for truncal acne was observed within 3 weeks after treatment, supporting sarecycline as an optimal choice for oral treatment of moderate to severe truncal acne.

J Drugs Dermatol. 2021;20(6):634-640. doi:10.36849/JDD.6204

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INTRODUCTION

Acne vulgaris is a chronic inflammatory disease that commonly affects the face, chest, and back. It is the most common inflammatory skin disease treated in ambulatory dermatology practice. Oral treatment for acne includes oral antibiotics, with second-generation broad-spectrum tetracyclines (doxycycline, minocycline) frequently prescribed by dermatologists for moderate to severe acne.1-4 Given that acne may result in permanent scarring and can lead to negative psychosocial impacts, including low self-esteem and emotional distress, suitable treatment options very important in clinical practice.1,5-8

Truncal acne, which affects the chest, back, and/or shoulders, has been shown to affect at least 50% of patients with acne, with 70% of patients desiring treatment even if they did not voluntarily report their truncal acne.1,2,9 Despite its prevalence, truncal acne does not have specific treatment guidelines and is often managed based on data used to support the treatment of facial acne. Given that outcomes from clinical studies on facial acne may not accurately reflect efficacy in truncal acne, studies in truncal acne are vital to providing suitable recommendations for management.

Current approaches for mild to moderate truncal acne include topical therapies such as topical retinoids alone or with benzoyl peroxide (BP) and/or topical antibiotics, azelaic acid, and dapsone.9 Oral antibiotics have been recommended for use in combination with topical therapies or combined oral
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