Development and Regulatory status
Feb 19: Filed in US. Application includes data from PIII PERFECT 1 and PERFECT 2 trials .
Nov 17: Galderma has completed a PIII trial in acne vulgaris (in children over 9 years of age, adolescents and adults) in the USA, Czech Republic, Germany, Hungary, Canada and Puerto Rico (NCT02566369). Results are awaited [3,4].
Feb 17: Galderma has completed two PIII trials for acne vulgaris (in children over 9 years of age, adolescents and adults) - one in the USA, Czech Republic, Germany and Hungary (NCT02189629), and another in the USA, Czech Republic, Hungary, Poland, Romania, Russia, Spain and Ukraine (NCT02556788). Results are awaited [3,4].
Trial or other data
Feb 19: Results of PIII PERFECT 1 and PERFECT 2 trials of Trifarotene in patients with moderate facial and truncal acne are published in Journal of the American Academy of Dermatology. The two identical multicenter, randomized, 12-week clinical trials of more than 2,400 patients met all primary and secondary efficacy endpoints, including IGA (facial acne), changes in inflammatory and non-inflammatory lesion counts and Physician Global Assessment (PGA) - truncal acne .
Nov 15: PIII study (NCT02566369) to assess efficacy and safety of CD5789 50μg/g cream applied once daily for 12 weeks in subjects with acne vulgaris begins. 1,200 patients aged 9 years and older will be recruited in the US. Primary outcome is success rate, defined as the percentage of subjects who achieve an Investigator Global Assessment (IGA) score of 1 (almost clear) or 0 (Clear) and at least a 2-grade improvement. Collection of these data should complete Mar 17 .