Cassiopea SpA announced the publication of positive safety data from a long-term extension study evaluating Clascoterone cream 1% for acne in the online issue of Journal of the American Academy of Dermatology (JAAD). The study demonstrated that Clascoterone cream 1%, has favorable long-term safety for the treatment of acne with low rates of treatment related adverse events (AEs). The multi-center, open-label, long-term extension study, CB-03-01/27, enrolled a total of 609 subjects from the pivotal studies /25 and /26, with 347 completing the study (n = 179 Clascoterone cream, n = 168 vehicle cream, original group assignment). Eligible patients for CB-03-01/27 must have completed one of the 12-week Phase III pivotal studies The two Phase III vehicle-controlled studies (CB-03-01/25 and CB-03-01/26) published in JAMA Dermatology showed Clascoterone cream significantly improved Investigator's Global Assessment (IGA) scores and lesion counts in subjects greater than 9 years of age with moderate to severe acne. Clascoterone and vehicle treated subjects from these pivotal Phase III trials participated in this study, CB-03-01/27; the extent of drug exposure and adverse events were assessed, evaluating long-term safety of Clascoterone cream. All subjects applied Clascoterone cream 1% twice daily to the face for up to twelve months and/or trunk for up to nine months. Patient visits occurred at months 1, 3, 6, and 9 where disease severity (IGA score), medication use, vital signs, AEs, treatment emergent adverse events (TEAEs), and serious adverse events (SAEs) were assessed in all patients. Subjects were assessed on the IGA 5-point scale from clear to severe; if subject was more than mild at an evaluation visit, the treatment regimen continued. Key safety findings showed that Clascoterone cream 1% had a low frequency of TEAE's over long-term observed treatment. Local skin reactions were mostly mild. Long-term efficacy was not a primary endpoint of this study.