Long‐term safety and efficacy of trifarotene 50 μg/g cream, a first‐in‐class RAR‐γ selective topical retinoid, in patients with moderate facial and truncal acne

Abstract

BackgroundTreatment for both facial and truncal acne has not sufficiently been studied.ObjectivesTo evaluate the long‐term safety and efficacy of trifarotene in both facial and truncal acne.MethodsIn a multicentre, open‐label, 52‐week study, patients with moderate facial and truncal acne received trifarotene 50 μg/g cream (trifarotene). Assessments included local tolerability, safety, investigator and physician's global assessments (IGA, PGA) and quality of life (QOL). A validated QOL questionnaire was completed by the patient at Baseline, Week 12, 26 and 52/ET.ResultsOf 453 patients enrolled, 342 (75.5%) completed the study. Trifarotene‐related treatment‐emergent adverse events (TEAEs) were reported in 12.6% of patients, and none was serious. Most related TEAEs were cutaneous and occurred during the first 3 months. Signs and symptoms of local tolerability were mostly mild or moderate and severe signs, and symptoms were reported for 2.2% to 7.1% of patients for the face and 2.5% to 5.4% for the trunk. Local irritation increased during the first week of treatment on the face and up to Weeks 2 to 4 on the trunk with both decreasing thereafter.At Week 12, IGA and PGA success rates were 26.6% and 38.6%, respectively. Success rates increased to 65.1% and 66.9%, respectively at Week 52. Overall success (both IGA and PGA success in the same patient) was 57.9% at Week 52.At Week 52 visit, 92/171 (53.8%) patients who had completed their assessments had scores from 0 to 1 (i.e. no effect of acne on their QOL) vs. 47/208 (22.6%) patients at Baseline visit.ConclusionIn this 52‐week study, trifarotene was safe, well tolerated and effective in moderate facial and truncal acne.

Loricrin: Past, Present, and Future

“…This "cracked mortar" similarly induces premature cornification as observed during vitamin A deficiency (VAD) [62]. This explains why vitamin A analogs are useful for managing skin conditions such as ARCI or acne caused by uncontrolled cornification in the interfollicular epidermis (ARCI) [148] or the follicular infundibulum (acne) [149], respectively. Likewise, VAD leads to ectopic cornification of mucosal squamous epithelium or transitional epithelium [150].…”

Subject Satisfaction with Trifarotene 50 μg/g Cream in the Treatment of Facial and Truncal Acne Vulgaris: A Case Series

“…Longer treatment may be expected to yield continuous improvement. In the single-arm, 52-week safety study, the beneficial effects of topical trifarotene on acne symptoms continued to improve after 12 weeks; the percentage of patients who reported a marked or complete improvement of facial acne was 41.4% at week 12, 54.8% at week 26 and 66.6% at week 52 [12]. Furthermore, the use of an applicator to apply medication on hard-to-reach areas of the back might be expected to further improve results for truncal acne.…”

“…The long-term safety study in 453 subjects, as reported by Blume-Peytavi et al . [ 12 ], demonstrated a manageable safety and tolerability profile with slightly better local tolerability on the trunk than on the face and high treatment compliance of 95.3% for both the face and trunk.…”

“…Previously developed retinoids were evaluated only in facial acne and not truncal acne, possibly due to safety concerns about treating a large area or a lack of consideration for truncal acne and its prevalence. Trifarotene 50 μg/g cream was evaluated in both moderate facial and truncal acne in two large-scale, randomized, double-blind, vehicle-controlled studies and one long-term safety study [ 10 , 12 ]. As physicians have had little real-world experience with its qualities, reporting from the patient’s perspective provides a valuable adjunct to the results of these pivotal studies.…”

Selective RAR agonists for acne vulgaris: A narrative review

“…Severe adverse effects occasionally reported were sunburn, allergic dermatitis, pain, and cutaneous erosion at the site of application. Adverse effects led to discontinuation of treatment in around 1.9% of subjects …”