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FDA Approves New Treatment for Facial and Truncal Acne

The FDA approved trifarotene cream 0.005% (Aklief) for the treatment of acne in patients aged 9 years and older. This is the first new retinoid molecule to receive FDA approval in over 20 years and also the first to be specifically studied for the treatment of both facial and truncal acne.

Approval for trifarotene cream was based on data from 2 pivotal Phase 3 clinical trials that included 2420 participants with moderate acne on the face and trunk. Data showed trifarotene cream, applied once daily, significantly reduced inflammatory lesions as early as 2 weeks on the face and 4 weeks on the back, shoulders and chest compared with vehicle.
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The most common adverse reactions included application site irritation, application site pruritis, and sunburn. Patients
may experience treatment-associated erythema, scaling, dryness, and stinging/burning, and can use a moisturizer to reduce the frequency of these adverse events or discontinue treatment. In addition, patients should avoid using wax to remove hair on treated skin.


Galderma receives FDA approval for Aklief (trifarotene) cream, 0.005%, the first new retinoid molecule for the treatment of acne in over 20 years [press release]. Fort Worth, TX: Galderma; October 4, 2019. Accessed October 8, 2019.


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