Galderma’s skin acne targeting cream meets all goals in Phase three test
February 28, 2019Galderma’s Phase 3 “Perfect” 2 clinical trials of Trifarotene, an investigational drug, against acne, with 2,400 patients met all primary and secondary efficacy endpoints, the company said Thursday.
Galderma said the data from the two trials were included in a New Drug Application (NDA) submitted to the U.S. Food and Drug Administration (FDA) for trifarotene for the treatment of facial and truncal acne.
“Acne frequently affects both the face and trunk and can cause permanent scarring. Many patients with facial and truncal acne feel self-conscious and are often reluctant to engage with other people,” said Howard Marsh, M.D., Vice President of Medical Affairs at Galderma, USA.
“Perfect 1 and Perfect 2 are the first and only large-scale randomized trials to evaluate a topical retinoid for the treatment of both facial and truncal acne,” said Thibaud Portal, Vice President of Prescription, Strategy and Innovation Group at Galderma.