The FDA has approved Trifarotene (Aklief) topical retinoid 0.005% for the treatment of acne vulgaris in patients 9 years of age and older.
Trifarotene is the first retinoid treatment to be approved by the FDA in over 20 years, granted to Galderma—a wholly-owned pharmaceutical subsidiary of Nestle.
"While retinoids are foundational therapies to treat acne, there has been little innovation in decades," Sandra Johnson, MD, an investigator in the clinical trials of AKLIEF Cream and a dermatologist at Johnson Dermatology in Fort Smith, AK, says in a statement.
The approval was based upon results from two identical phase three trials that included 2,420 patients. According to a release, the primary endpoints of the study showed that trifarotene cream significantly reduced inflammatory lesions as early as two weeks on the face, and four weeks on the back, shoulders, and chest when compared to vehicle. The cream was reportedly well tolerated on the face, back, shoulders, and chest of participants.
Trifarotene comes with warnings of potential skin irritation including erythema, scaling, dryness, and stinging/burning, as well as recommendations to avoid ultraviolet light and environmental exposure.
Adverse reactions reported throughout the clinical trials included application site irritation, application site pruritus, and sunburn.
According to a release, 45g pumps of Aklief are expected to be available by November.