Safety Overview In study SC1401, TEAEs occurred in 29.3% (141/481) of patients in the sarecycline group and 29.8% (144/483) of patients in the placebo group. In study SC1402, TEAEs occurred in 25.0% (128/513) of patients in the sarecycline group and 26.7% (137/513) of patients in the placebo group (Table 2).The most common TEAEs (in ≥ 2% of patients in either group) were nausea (4.6% sarecycline, 2.5% placebo), nasopharyngitis (3.1% and 1.7%), headache (2.7% in both groups), and vomiting (2.1% and 1.4%) in study SC1401, and nasopharyngitis (2.5% sarecycline and 2.9% placebo) and headache (2.9% and 4.9%) in study SC1402. Vulvovaginal candidiasis and vulvovaginal mycotic infection were rare in the sarecycline group, occurring in 1.1% and 0.7%, respectively, of female patients in SC1401 and 0.3% and 1.0% of female patients in SC1402, all of whom completed the study. They did not occur in the placebo group in either study.TEAEs considered by the investigator to be related or possibly related to study treatment occurred in 1.9% (9/481) and 8.7% (42/481), respectively, of patients in the sarecycline group, and 0.4% (2/483) and 8.3% (40/483), respectively, of patients in the placebo group in study SC1401. TEAEs considered by the investigator to be related or possibly related to study treatment occurred in 1.6% (8/513) and 6.4% (33/513), respectively, of patients in the sarecycline group, and 0.6% (3/513) and 5.1% (26/513), respectively, of patients in the placebo group in study SC1402.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
Safety Overview In study SC1401, TEAEs occurred in 29.3% (141/481) of patients in the sarecycline group and 29.8% (144/483) of patients in the placebo group. In study SC1402, TEAEs occurred in 25.0% (128/513) of patients in the sarecycline group and 26.7% (137/513) of patients in the placebo group (Table 2).The most common TEAEs (in ≥ 2% of patients in either group) were nausea (4.6% sarecycline, 2.5% placebo), nasopharyngitis (3.1% and 1.7%), headache (2.7% in both groups), and vomiting (2.1% and 1.4%) in study SC1401, and nasopharyngitis (2.5% sarecycline and 2.9% placebo) and headache (2.9% and 4.9%) in study SC1402. Vulvovaginal candidiasis and vulvovaginal mycotic infection were rare in the sarecycline group, occurring in 1.1% and 0.7%, respectively, of female patients in SC1401 and 0.3% and 1.0% of female patients in SC1402, all of whom completed the study. They did not occur in the placebo group in either study.TEAEs considered by the investigator to be related or possibly related to study treatment occurred in 1.9% (9/481) and 8.7% (42/481), respectively, of patients in the sarecycline group, and 0.4% (2/483) and 8.3% (40/483), respectively, of patients in the placebo group in study SC1401. TEAEs considered by the investigator to be related or possibly related to study treatment occurred in 1.6% (8/513) and 6.4% (33/513), respectively, of patients in the sarecycline group, and 0.6% (3/513) and 5.1% (26/513), respectively, of patients in the placebo group in study SC1402.
