Trifarotene: FDA grants first approval for acne treatment after 20 years

The U.S. Food and Drug Administration (FDA) has granted approval to Galderma's AKLIEF (Trifarotene) cream 0.005% meant for topical application. With this, trifarotene becomes the first new retinoid molecule to receive U.S. FDA approval for the treatment of acne in more than 20 years.

It exhibits its action by selectively targeting retinoic acid receptor (RAR) gamma, the most common RAR found in the skin.

Acne is a common skin condition involving blockage and/or inflammation of hair follicles and their glands, which can present as non-inflammatory lesions, inflammatory lesions, or a mixture of both, affecting the face, back and chest. According to the Global Burden of Disease study, acne vulgaris affects 85 percent of young adults aged 12–25 years around the world.

AKLIEF Cream is the first topical treatment specifically studied and proven to treat both facial (forehead, cheeks, nose and chin) and truncal (chest, shoulders and back) acne, offering healthcare professionals and acne patients another treatment option.

“While retinoids are foundational therapies to treat acne, there has been little innovation in decades,” said Sandra Johnson, FAAD, an investigator in the clinical trials of AKLIEF Cream and a dermatologist at Johnson Dermatology in Fort Smith, Arkansas, said in a press release. “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.”

The FDA approval is based on data from the 2 identical 12-week, randomized, multicenter, parallel-group, double-blind, vehicle-controlled clinical trials of 2420 patients. The results of which showed that:

• AKLIEF Cream significantly reduced inflammatory lesions as early as two weeks on the face and four weeks on the back, shoulders and chest compared to vehicle.


• AKLIEF Cream was well tolerated when used on the face, back, shoulders and chest.


• The most common adverse reactions (incidence>1%) included application site irritation, application site pruritus (itching) and sunburn.

“The approval of AKLIEF Cream underscores our ability to bring new active molecules to the community, and innovate even in well-established therapeutic classes. It is consistent with our intent to change the paradigm of how even the most common and frustrating skin diseases are treated, including acne,” said Thibaud Portal PhD, Galderma Global Vice President, Prescription. “We are pleased to add this new treatment option, with proven efficacy in facial and truncal acne, to our innovative and differentiated portfolio of acne treatments.”

AKLIEF Cream is expected to be available in the United States in November 2019. It will be provided in a 45-gram pump. Galderma is working closely with payers, providers and pharmacy benefit managers to ensure broad and rapid access to AKLIEF Cream. The company will also offer a patient savings card program, Galderma CareConnect*.

Important Safety Information

Indication: AKLIEF (trifarotene) Cream, 0.005% is a retinoid indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.

Adverse Events: The most common adverse reactions (incidence ≥ 1%) in patients treated with AKLIEF Cream were application site irritation, application site pruritus (itching), and sunburn.

Warnings/Precautions: Patients using AKLIEF Cream may experience erythema, scaling, dryness, and stinging/burning. Use a moisturizer from the initiation of treatment, and, if appropriate, depending upon the severity of these adverse reactions, reduce the frequency of application of AKLIEF Cream, suspend or discontinue use. Avoid application of AKLIEF Cream to cuts, abrasions or eczematous or sunburned skin. Use of “waxing” as a depilatory method should be avoided on skin treated with AKLIEF Cream. Minimize exposure to sunlight and sunlamps. Use sunscreen and protective clothing over treated areas when exposure cannot be avoided.