Trifarotene cream was safe and well tolerated in the treatment of moderate facial and truncal acne in a multicenter, open-label phase 3 clinical trial.
Three hundred forty-eight of 453 patients (76.5%) completed the 52-week study at sites in the U.S. and Europe. The mean patient age was 18.3 years and ranged from 9 to 54 years.
Trifarotene cream 50 µg/g (Nestlé Skin Health – Galderma) was first applied at the study site, and for the first 12 weeks patients applied the cream once daily in the evening after washing and drying the skin. Treatment was continued or discontinued based on treatment success criteria.
Investigator Global Assessment (IGA) and Physician Global Assessment (PGA) success rates continuously improved over time. IGA rates improved from 26.6% at week 12 to 65.1% at week 52, and PGA rates improved from 38.6% at week 12 to 66.9% at week 52.
At week 12, 41.4% of patients reported a marked or complete improvement of facial acne, which steadily improved to 54.8% at week 26 and 66.6% at week 52.
Quality of life scores also showed improvement. At week 52, 92 of 171 patients (53.8%) who completed assessments had scores from 0 to 1, meaning the acne had no effect on their quality of life, compared with 47 of 208 patients (22.6%) at baseline.
The researchers reported a significant therapeutic benefit at 52 weeks, with 57.9% of patients experiencing overall success.
“This represents a new generation of retinoids, with a RAR- selectivity that is highly expressed in the skin,” Ulrike Blume-Peytavi, MD, of the department of dermatology and allergy, Charité-Universitätsmedizin Berlin, Germany, and colleagues wrote. “It has a good in vivo metabolic stability in cultured keratinocytes and is rapidly metabolized in human liver microsomes, predicting an improved safety profile due to low systemic levels.”
Fifty-three patients (11.6%) requested treatment discontinuation. Four hundred sixty-eight treatment-emergent adverse events were reported by 218 patients (48.1%) during the entire study period. Fifty-seven patients (12.6%) had cutaneous adverse events related to trifarotene, and 13 patients (2.9%) had adverse events related to trifarotene that led to discontinuation. Of the 10 serious treatment-emergent adverse events, none were related to trifarotene.
Pruritus was the most common cutaneous trifarotene-related treatment-emergent adverse event in 4.6% patients, followed by irritation in 4.2% and sunburn in 1.8%. These events were mostly mild in severity and observed on treated areas.
This study is the first to evaluate a treatment for both moderate facial acne and truncal acne for long-term tolerability and safety, according to researchers. – by Abigail Sutton
Disclosures: Blume-Peytavi reports she has received honoraria lectures from Nestlé Skin Health – Galderma and fees for the conduct of clinical studies. Please see the study for all other authors’ relevant financial disclosures.