Today, the U.S. Food and Drug Administration (FDA) approved the topical retinoid trifarotene 0.005% (AKLIEF, Galderma) for the treatment of acne vulgaris.
“AKLIEF Cream is the first new retinoid molecule to be FDA approved for the treatment of acne in over 20 years and is the first topical treatment specifically studied to treat both facial and truncal (chest, shoulders and back) acne,” says Sandra Johnson, M.D., an investigator in the clinical trials of AKLIEF Cream and a dermatologist at Johnson Dermatology in Fort Smith, Ark. “Additionally, AKLIEF Cream is potent and effective at low doses, making it suitable for use across large areas. It is also the only topical retinoid that specifically targets retinoic acid receptor gamma (RAR-gamma), the most common retinoic acid receptor found in the skin."
Trifarotene 0.005% is expected to be available in the United States in November 2019. It will be provided in a 45-gram pump, according to Galderma.
Researchers studied the topical’s safety and efficacy, publishing the results of two phase 3 studies PERFECT 1 and PERFECT 2 in the June 2019 Journal of the American Academy of Dermatology. The paper details results from two 12-week clinical trials of once daily trifarotene versus vehicle in patients 9 years and older with moderate facial and truncal acne. In total, more than 2,400 were studied at 200 sites globally.
Outcomes from trifarotene were significantly superior to vehicle in reducing inflammatory and noninflammatory lesion counts on the face and trunk, the authors report. This is one of the few studies in the literature to report outcomes of acne treatment to the chest in back, despite that truncal acne is thought to occur in about 56% of acne patients, according to the paper.
Local irritation related to trifarotene included erythema, scaling, dryness and stinging and burning — side effects that were mostly mild to moderate, transient and consistent with topical retinoid dermatitis. Some of the subjects discontinued trifarotene due to adverse events, including 1.9% in PERFECT 1 and 1.2% in PERFECT 2.
Dr. Johnson has served as an investigator, consultant, and speaker for Galderma.