Once-Daily Oral Sarecycline 1.5 mg/kg/day Is Effective for Moderate to Severe Acne Vulgaris: Results from Two Identically Designed, Phase 3, Randomized, Double-Blind Clinical Trials

September 2018 | Volume 17 | Issue 9 | Original Article | 987 | Copyright © September 2018


Angela Moore MD,a Lawrence J. Green MD,b Suzanne Bruce MD,c Neil Sadick MD,d Eduardo Tschen MD MBA,e Philip Werschler MD FAAD FAACS,f Fran E. Cook-Bolden, MD,g Sunil S. Dhawan MD,h Douglass Forsha MD,i Michael H. Gold MD FAAD,j Scott Guenthner MD,k Steven E. Kempers MD,l Leon H. Kircik MD,m Jennifer L. Parish MD,n Marta I. Rendon MD,o Phoebe Rich MD,p Linda Stein-Gold MD,q Stephen K. Tyring MD PhD,r Robert A. Weiss MD FAAD,s Adnan Nasir MD,t Carsten Schmitz MD PhD,u* Terry I. Boodhoo MS,u Alexandre Kaoukhov MD,u,* and David R. Berk MDu

aArlington Research Center, Inc., Arlington, TX bLawrence J. Green, MD, LLC, George Washington University School of Medicine, Washington, DC cSuzanne Bruce and Associates, PA, Houston, TX dSadick Research Group, New York, NY eAcademic Dermatology Associates, Albuquerque, NM fPremier Clinical Research, Spokane, WA gSkin Specialty Dermatology, New York, NY hCenter for Dermatology Clinical Research, Inc, Fremont, CA iJordan Valley Dermatology Center, Jordan, UT jTennessee Clinical Research Center, Nashville, TN kThe Dermatology Center of Indiana, PC, Plainfield, IN lAssociated Skin Care Specialists, Fridley, MN mDermResearch, PLLC, Louisville, KY nParish Dermatology, Philadelphia, PA oRendon Center, Boca Raton, FL pOregon Dermatology and Research Center, Portland, OR qHenry Ford Health System, West Bloomfield, MI rUniversity of Texas Health Science Center, Department of Dermatology, Houston, TX sLaser Skin & Vein Institute, Hunt Valley, MD tWake Research Associates, Raleigh, NC uAllergan plc, Irvine, CA *Former employee

Skindex-16 questionnaire scale scores and total scores were summarized by treatment and visit in the ITT population. Change from baseline in these scores was calculated for each treatment and analyzed using the ANCOVA model. Adjusted least squares means with associated 95% confidence intervals (CIs) from the ANCOVA model were analyzed for each treatment and difference between treatments.Safety evaluations were conducted in all patients who received ≥1 dose of study drug. TEAEs were summarized by the number and percentage of patients reporting a TEAE by treatment.

RESULTS

Patient Demographics and Baseline Disease Characteristics Demographic variables were similar across treatment groups in both studies (Table 1). Baseline disease characteristics, including facial inflammatory and noninflammatory lesion counts and facial IGA scores, were similar across treatment groups in both studies.The majority of patients (SC1401: 85.2%; SC1402: 84.8%) completed the studies (Figure 2).Efficacy IGA success rate was significantly greater in the sarecycline group than in the placebo group in the ITT population beginning at week 6 in study SC1402 and at week 9 in study SC1401 and continuing through week 12 in both studies. In study SC1401, 21.9% of the sarecycline group versus 10.5% of the placebo group achieved IGA success at week 12 (P less than 0.0001; Figure 3). In study SC1402, the IGA success rate at week 12 was 22.6% for sarecycline versus 15.3% for placebo (P equals 0.0038).Mean percentage change from baseline in inflammatory lesion count was significantly greater in the sarecycline group than the placebo group at the first follow-up visit at week 3 and continued through week 12 in both studies (Figure 4). In study SC1401, the mean percentage change from baseline in inflammatory lesion count at week 12 was −51.8% in the sarecycline group versus −35.1% in the placebo group (P less than 0.0001). In study SC1402, the mean percentage change from baseline in inflammatory lesion count at week 12 was −49.9% for sarecycline versus −35.4% for placebo (P less than 0.0001).Mean absolute change from baseline in noninflammatory lesion count was significantly greater in the sarecycline group than the placebo group beginning at week 6 in study SC1401 and at week 9 in study SC1402 and continuing through week 12 in both studies (Figure 5). In study SC1401, sarecycline-treated patients had a mean absolute change from baseline in noninFigure3Figure4
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