Trifarotene cream effective, safe in adolescent facial, truncal acne
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Key takeaways:
- 30.4% of trifarotene-treated patients achieved IGA success vs. 17.6% of those treated with vehicle.
- Adverse events occurred in 28.3% of trifarotene-treated patients vs. 23.5% of vehicle-treated patients.
NEW ORLEANS — Trifarotene monotherapy, a convenient topical treatment, offers clinical efficacy, safety and tolerability in adolescents with moderate facial and truncal acne vulgaris, according to a poster presented here.
“Acne vulgaris is very common among adolescents and young adults,” Adelaide Hebert, MD, chief of pediatric dermatology at McGovern School of Medicine and Children’s Memorial Hermann Hospital, and colleagues wrote in their poster presented at the American Academy of Dermatology Annual Meeting. “Clinicians who provide care to these patients need to have a plan of action for assessing and managing acne in daily practice.”
In this post-hoc analysis of two phase 3 pivotal trials, researchers evaluated the efficacy, safety and tolerability of trifarotene 0.005% cream in patients aged 12 to 17 years with moderate facial and truncal acne.
The studies were identical, double-blind, multicenter studies that included 575 patients (mean age, 15 years; 55.3% boys; 91.1% white) randomly assigned to trifarotene 0.005% and 553 patients (mean age, 15.1 years; 56.1% boys; 88.8% white) randomly assigned to vehicle.
Efficacy assessments among facial acne showed that patients on trifarotene outperformed those on vehicle cream in IGA success (30.4% vs. 17.6%; P < .001), reduction in inflammatory lesions (56.8% vs. 43.2%; P < .001) and reduction in noninflammatory lesions (50.1% vs. 36%; P < .001).
Additionally, efficacy assessments among truncal acne showed similar results in Physician Global Assessment success rates (35.1% vs. 23.5%; P < .001) and reduction of inflammatory lesions (58.5% vs. 45.5%; P < .001). However, those on vehicle saw more success in reduction of noninflammatory lesion treatments (37.9%) compared with trifarotene-treated patients (26.5%; P < .001).
According to the poster, rate of adverse events was low and acceptable with trifarotene maintaining a favorable tolerability profile. Adverse events occurred in 28.3% of patients treated with trifarotene compared with 23.5% of patients treated with vehicle.
Most adverse events were mild to moderate and included symptoms typical of topical retinoid therapy including administration site irritation (11.1% vs. 1.3%), infections (10.3% vs. 13.7%) and sunburn (3.3% vs. 0.7%). The authors reported that adverse events usually resolved within the first 4 weeks of treatment and decreased with continued use of trifarotene.
However, a small percentage of patients did discontinue treatment in both the trifarotene and vehicle groups due to adverse events (1.9% vs. 0.2%, respectively).
“Trifarotene monotherapy was associated with good clinical efficacy, safety and tolerability in adolescent subjects,” the authors wrote. “Once-daily application offers convenience for patients, and the low concentration of trifarotene makes it well suited to use on large body surface areas such as the trunk.”
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Hebert, A, et al. Poster. Phase 3 pooled analysis of safety and efficacy of trifarotene 0.005% cream within the adolescent population. Presented at: American Academy of Dermatology Annual Meeting; March 17-21, 2023; New Orleans.
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