Aklief (trifarotene)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company:

Approval Status:

Approved October 2019

Specific Treatments:

acne vulgaris

Therapeutic Areas

Find Related Trials for The Following Conditions

General Information

Aklief (trifarotene) is a topical retinoid that selectively targets retinoic acid receptor (RAR) gamma, the most common RAR found in the skin.

Aklief is specifically indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.

Aklief is supplied as a cream for topical administration. Apply a thin layer of Aklief Cream to the affected areas once daily, in the evening, on clean and dry skin. 
 
• One pump actuation should be enough to cover the face (i.e., forehead, cheeks, nose, and chin). 

• Two actuations of the pump should be enough to cover the upper trunk (i.e., reachable upper back, shoulders and chest). One additional pump actuation may be used for middle and lower back if acne is present.

The use of a moisturizer is recommended as frequently as needed from the initiation of treatment.  Avoid contact with the eyes, lips, paranasal creases, mucous membranes.

Clinical Results

FDA Approval

The FDA approval was based on data from two pivotal Phase 3 clinical trials of once-daily Aklief Cream in patients with moderate acne on the face and trunk. The two identical 12-week, randomized, multicenter, parallel group, double-blind, vehicle-controlled clinical trials enrolled 2,420 patients. Results 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. 

Side Effects

Adverse effects associated with the use of Aklief cream may include, but are not limited to, the following:

application site irritation

application site pruritus

sunburn

Mechanism of Action

Trifarotene is 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 exact process by which trifarotene ameliorates acne is unknown.

Additional Information

For additional information regarding Aklief or acne vulgaris please visit the Aklief web page.