Study data published in the Journal of the European Academy of Dermatology and Venereology support the long-term safety and efficacy of trifarotene for the treatment of moderate facial and truncal acne.
In a multicenter, phase 3, open-label, 52-week study (ClinicalTrials.gov Identifier: NCT02189629), patients with moderate facial and truncal acne received daily treatment with trifarotene 50 μg/g cream, a first-in-class RAR-γ-selective topical retinoid. Patients 9 years of age and older with clinician-confirmed moderate facial and truncal acne were eligible for inclusion. Tolerability and efficacy parameters were assessed at baseline and at weeks 12, 20, 26, 38, and 52. Investigator global assessment (IGA) and physician global assessment (PGA) were used as efficacy parameters for facial and truncal acne, respectively. A validated quality of life (QoL) questionnaire was completed by patients at baseline and at weeks 12, 26, and 52. Treatment-emergent adverse events (TEAEs) were assessed throughout the study period. Treatment success was defined at a particular study visit if the patient had an IGA or PGA score of 0 or 1, as well as a ≥2-grade improvement from baseline.
Among 453 enrolled patients, 342 (75.5%) completed the study. At week 12, IGA and PGA success rates were 26.6% and 38.6%, respectively; these rates increased to 65.1% and 66.9% at week 52. More than half (57.9%) of patients achieved both IGA and PGA success at study conclusion.
The proportion of patients reporting marked or complete improvement of facial acne was 41.4% at week 12, 54.8% at week 26, and 66.6% at week 52. At week 52, 53.8% of patients endorsed no effect of acne on their QoL, compared with 22.6% of patients reporting no effect at baseline.
Overall, 468 TEAEs were reported by 218 patients, among which 57 reported cutaneous trifarotene-related AEs. The most commonly reported cutaneous AEs were pruritus, irritation, and sunburn, reported by 4.6%, 4.2%, and 1.8% of patients, respectively. Severe trifarotene-related TEAEs occurred in 3 (0.7%) patients; 16 (3.5%) patients discontinued the study due to TEAEs.
Per these data, trifarotene was well tolerated and effective for the majority of study participants. The present study design may also be an effective template for further long-term studies of truncal acne treatment methods.
Disclosure: This clinical trial was supported by Nestlé Skin Health Care. Please see the original reference for a full list of authors’ disclosures.
Blume-Peytavi U, Fowler J, Kemény L, et al. Long-term safety and efficacy of trifarotene 50μg/g cream, a first-in-class RAR-γ selective topical retinoid, in patients with moderate facial and truncal acne [published online July 15, 2019]. J Eur Acad Dermatol Venereol. doi:10.1111/jdv.15794