Is Trifarotene approved by the FDA?

Yes, trifarotene is FDA approved. The FDA approved trifarotene on October 4, 2019, for the treatment of acne vulgaris. It is marketed under the brand name Aklief.

What is Trifarotene?

Trifarotene is a topical medication, classified as a topical acne agent, used to treat acne vulgaris in both adults and children aged 9 years and older. This medication works similarly to vitamin A by promoting skin cell turnover, which helps to renew the skin, thereby improving its appearance and texture.

How to Use Trifarotene

Trifarotene is available as a topical cream (0.005%) and should be applied once daily in the evening to clean and dry skin. A thin layer of the cream should be applied to the affected areas. For the face, one pump actuation is usually sufficient, while two actuations are generally enough to cover the upper trunk. Additional pump actuations may be used for the middle and lower back if needed.

Side Effects and Warnings

Common Side Effects:

• Itching or skin irritation
• Sunburn

Serious Side Effects:

• Severe skin irritation (burning, stinging, scaling)
• Severe skin redness or dryness

If any severe side effects occur, discontinue use and contact a healthcare provider immediately.

Precautions:

• Avoid using on open wounds, sunburns, abrasions, or irritated skin.
• Avoid contact with eyes, mouth, lips, and nose creases.
• Use sunscreen (SPF 30 or higher) and protective clothing when outdoors as trifarotene can increase sun sensitivity.

Storage and Handling

Store trifarotene at room temperature, away from heat and light. Ensure the tube is tightly closed when not in use.

Special Considerations

• Do not use trifarotene if you have a history of eczema or other skin problems without consulting a healthcare provider.
• If pregnant or breastfeeding, consult with a doctor before using this medication. If applied to the chest, avoid areas that may come into contact with the baby’s mouth.

Drug Interactions

Trifarotene is a topical medication and is unlikely to be affected by other drugs taken orally or otherwise. However, it is important to inform healthcare providers about all medications being used, including over-the-counter drugs, vitamins, and herbal supplements.

Conclusion

Trifarotene, under the brand name Aklief, is an FDA-approved topical treatment for acne vulgaris in patients aged 9 years and older. Its approval on October 4, 2019, marked a significant advancement in acne treatment options. As with any medication, adherence to usage instructions and awareness of potential side effects are crucial for effective and safe treatment. Always consult with healthcare providers for personalized medical advice.

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