Pivotal Phase 3 Trials of Trifarotene in Patients with Moderate Facial and Truncal Acne Meet All Efficacy Endpoints

Results from the pivotal Phase 3 PERFECT 1 and PERFECT 2 clinical trials of once-daily trifarotene 50 µg/g cream in patients with moderate acne on the face and trunk, published in the June issue of Journal of the American Academy of Dermatology, met all primary and secondary efficacy endpoints. Trifarotene, an investigational drug, is an new molecule and a unique retinoid receptor agonist that selectively targets retinoic acid receptor gamma (RAR-γ).

The two randomized, double-blind, vehicle-controlled studies evaluated the efficacy and safety of once-daily trifarotene 50 µg/g cream compared with vehicle cream over 12 weeks. Patients aged nine years or older with moderate acne vulgaris on the face and trunk (mean age: 19 years) were randomized to once-daily trifarotene 50 µg/g cream or vehicle cream at bedtime. A total of 200 sites in the United States, Canada, Europe and Russia enrolled 2,420 patients.

The three co-primary efficacy endpoints were IGA success rate on the face (clear/almost clear and at least a 2 grade improvement from baseline) at week 12, and absolute change from baseline in facial inflammatory and non-inflammatory lesion counts from baseline to week 12. The three secondary efficacy endpoints were Physician Global Assessment (PGA) success rate on the trunk (clear/almost clear and at least a 2 grade improvement from baseline) at week 12, and absolute change in truncal inflammatory and non-inflammatory lesion counts from baseline to week 12.3 Safety was assessed through recording of adverse events, local tolerability, vital signs and routine laboratory testing. The two trials met all primary and secondary efficacy endpoints, including IGA/facial acne, changes in inflammatory and non-inflammatory lesion counts, and PGA/truncal acne. The majority of adverse events were local cutaneous irritation mainly during the first weeks of treatment, which improved thereafter.

Data from the two trials were included in a New Drug Application (NDA) submitted to the 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, MD, Vice President of Medical Affairs at Galderma, USA. "Despite the negative outcomes experienced, truncal acne has been insufficiently studied."

"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. "This underscores Galderma's commitment to innovation, the dermatology community and patients, and we are excited about the potential of trifarotene and its novel features. We hope to bring this next-generation topical retinoid to patients suffering from acne as soon as possible."