Aklief cream safely improves facial, truncal acne in adolescents

Treatment with Aklief monotherapy for adolescent facial and truncal acne was safe, effective and well-tolerated, according to a study published in the Journal of Drugs in Dermatology.

Aklief (trifarotene 0.005% cream, Galderma) is a retinoid that has been approved for patients aged 9 years and older specifically formulated at a low concentration to enhance safety.

“Effective acne management strategies include topical retinoids as a foundation of treatment,” Lawrence F. Eichenfield, MD, of Rady Children’s Hospital in San Diego, and colleagues wrote. “Retinoids are considered the core group of acne therapeutics due to multiple actions, including comedolytic and anti-inflammatory effects.”

Eichenfield and colleagues conducted a pooled analysis of two phase 3 studies that comprised 12 weeks of treatment with either trifarotene once daily or vehicle cream.

The studies in total included 1,128 patients aged 12 to 17 years, of whom 571 received treatment with trifarotene and 557 received vehicle. At baseline, all patients had moderate facial acne and all but two patients in the treatment group had moderate truncal acne.

For facial acne, the IGA success rate at 12 weeks was 30.4% in the treatment group compared with 17.6% in the vehicle group (P < .001). Reduction of both inflammatory and noninflammatory lesion counts was also greater in the treatment group (both, P < .005%).

For truncal acne, the PGA success rate was 35.1% in the treatment group and 23.5% in the vehicle group (P < .001). Treatment led to a greater reduction in inflammatory lesions (58.5% vs. 45.5%; P < .001) compared with the vehicle group.

The number of treatment-emergent adverse events was slightly higher among patients in the treatment group (28.3% vs. 23.5%). The most common adverse events were administration site irritation (11.1%) and infections (10.3%). Adverse events led to a discontinuation rate of 1.9% in the treatment group.

Overall, patients in the treatment group reported that they were satisfied with trifarotene. Also, 76.5% of treated patients rated the change in facial acne as moderate or better improvement.

“While it has been reported that some physicians believe topical retinoids are unnecessarily expensive, it should be noted that over-the-counter preparations that are less costly may not be as efficacious in real-world use — since patients tend to stop use as soon as acne begins to clear, which typically results in relapse,” Eichenfield and colleagues wrote. “Many patients report having given trial to OTC preparations prior to seeking medical advice for acne, and those who will respond well to OTC agents typically self-select out of the group seeking care.”

The researchers added that appropriate education and working with patients to determine insurance coverage and preferences is essential.

“Trifarotene is the only topical retinoid robustly studied in both face and trunk and offers a convenient single-agent regiment proven efficacious and safe for acne in adolescents,” they concluded.