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

Background: Treatment for both facial and truncal acne has not sufficiently been studied.

Objectives: To evaluate the long-term safety and efficacy of trifarotene in both facial and truncal acne.

Methods: In 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.

Results: Of 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.

Conclusion: In this 52-week study, trifarotene was safe, well tolerated and effective in moderate facial and truncal acne.

Figure 1

Patient disposition. Screened patients were those who had signed the ICF. Enrolled patients were those who did not fail screening and were given trifarotene at Baseline visit. ^aOf the 455 patients enrolled, 453 were treated (i.e. two patients did not apply study drug and returned the unused study drug).

Figure 2

Local tolerability by visit: mean scores of signs and symptoms on the face (SAF population). Safety Population (SAF): All patients that were randomized and applied the study drug at least once. It includes all patients with facial acne/trunk acne and facial acne/without truncal acne. Local tolerability parameters including erythema, scaling, dryness and stinging/burning were evaluated at each visit on a 4‐point scale (0 = none, 1 = mild, 2 = moderate and 3 = severe) at Baseline and at Weeks 12, 20, 26, 38 and 52/ET.

Figure 3

Local tolerability by visit: mean scores of signs and symptoms on the trunk (SAFT population). Safety PGA Population (SAFT): All patients that were randomized and applied the study drug at least once on the trunk. It includes all patients with facial acne/truncal acne. Local tolerability parameters including erythema, scaling, dryness and stinging/burning were evaluated at each visit on a 4‐point scale (0 = none, 1 = mild, 2 = moderate and 3 = severe) at Baseline and at Weeks 12, 20, 26, 38 and 52/ET.

Figure 4

Evolution of the percent investigator's global assessment and physician global assessment success rates at baseline and weeks 12, 20, 26, 38 and 52 (SAFT population). Investigator's Global Assessment (IGA) and Physician Global Assessment (PGA) were scored on a 5‐point scale (from 0 = clear to 4 = severe).

Figure 5

Evolution of the overall percent investigator's global assessment and physician global assessment success in the same patient over 52 weeks (SAFT population). Overall treatment success was defined at a particular study visit if the same patient had an IGA/PGA score of “clear” or “almost clear” and at least a 2‐grade improvement from Baseline at any study visit.

Figure 6

Acne severity of two patients at different time points. Patient n°1: Face, Acne severity on the face decreased from an IGA score of 3 to an IGA score of 1 at 12 weeks; Trunk, Acne severity on the trunk decreased from a PGA score of 3 to a PGA score of 2 at Week 12. Patient n°2: Face, Acne severity on the face decreased from an IGA score of 3 to an IGA score of 1 after 52 weeks.