The Food and Drug Administration (FDA) has approved Aklief Cream 0.005% (trifarotene; Galderma) for the topical treatment of acne vulgaris in patients 9 years of age and older.
Aklief contains trifarotene, an agonist of retinoic acid receptors (RAR), with particular activity at the gamma subtype of RAR; stimulation of RAR results in modulation of target genes which are associated with various processes, including cell differentiation and mediation of inflammation.
The approval of Aklief was based on data from 2 parallel group, double-blind, vehicle-controlled clinical trials conducted in 2420 patients with moderate facial and truncal acne vulgaris. The co-primary end points of the studies were based on success as measured by Investigator’s Global Assessment (IGA) scale for the face and a 5-point Physician’s Global Assessment (PGA) scale for the trunk; success was defined as a score of 1 (almost clear) or 0 (clear) and at least a 2-grade improvement from baseline to Week 12.
Results at Week 12 for facial acne showed that 29.4% of patients in Study 1 and 42.3% of patients in Study 2 treated with Aklief had IGA success compared with 19.5% and 25.7% of placebo-treated patients, respectively. As for the trunk, 35.7% of patients in Study 1 and 42.6% of patients in Study 2 treated with Aklief achieved PGA success vs 25.0% and 29.9% with placebo, respectively.
With regard to safety, the most common treatment-emergent adverse reactions reported during the trials included application site irritation, application site pruritus, and sunburn. The use of a moisturizer is recommended as frequently as needed from the initiation of treatment.
“While retinoids are foundational therapies to treat acne, there has been little innovation in decades,” said Sandra Johnson, MD, FAAD, an investigator in the clinical trials of Aklief Cream and a dermatologist at Johnson Dermatology in Fort Smith, Arkansas. “With the approval of Aklief Cream, I am excited to offer my patients a unique, highly targeted retinoid that reduces inflammatory lesions on the face, back, chest and shoulders, that has also been shown to be safe and well-tolerated.”
Each gram of Aklief Cream contains 50mcg of trifarotene. The product is expected to be available in a 45g pump in November 2019.
For more information visit galderma.com.