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



patients with back acne were pooled and analyzed from both phase 3 studies. In the chest acne group, 421 patients received placebo and 418 patients received sarecycline. In the back-acne group, 561 patients received placebo and 573 patients received sarecycline. Demographic variables and baseline disease characteristics were similar across treatment groups for both chest and back populations (Table 1). Most patients in both chest and back populations had an IGA score of 2 (53–67%).

Pooled IGA Success in Chest Acne
In the individual studies, IGA success rate was significantly greater in the sarecycline group compared to the placebo group at weeks 6 (21.5% vs 14.6%, respectively; P=0.020) and 12 (29.6% vs 19.6%, respectively; P=0.006) for study SC1401 and at week 12 (21.6% vs 36.6%, respectively; P<0.001) for study SC1402 (Figure 2A-B). Pooled IGA success rate was significantly greater in the sarecycline group than in the placebo group at week 3 (11.84%