The patient · 2025
Patient Insights on Acne Hyperpigmentation, Trifarotene, and Skincare: 6-Month, LEAP Phase 4 Qualitative Exit Interview Findings.
СтатьяРандомизированное исследованиеКлиническое исследование IV фазыМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Dias-Barbosa Carla, Taylor Natalie, Chan Kevin, York Jean Philippe, Puelles Jorge, Chavda Rajeev
Аннотация
BACKGROUND: Acne-induced hyperpigmentation (AIH) has a considerable impact on patients' quality of life (QoL). In the phase 4 LEAP trial, patients treated with the topical retinoid trifarotene showed faster improvement in AIH compared to patients treated with its vehicle cream (VC) at week (W) 12.
OBJECTIVE AND METHODS: This was a cross-sectional, blinded, qualitative interview study embedded in the phase 4 LEAP trial (NCT05089708), which assessed the safety and efficacy of trifarotene (50 μg/g) versus its VC in the treatment of acne. The study was conducted with a subsample of participants between June and November 2022 at a subset of nine clinical sites in the United States (US). Participants were adults (18-34 years) who were randomized to receive trifarotene (50 μg/g) or VC, along with a daily skincare regimen (moisturizer, cleanser, photoprotection). After confirming participants' end-of-treatment visit during W24, telephone interviews were conducted using a semi-structured interview guide. Participants' perspectives regarding baseline AIH symptoms, changes in AIH from baseline to W24, and treatment satisfaction were assessed and analyzed using thematic analysis in ATLAS.ti to better understand trends across trial arms.
RESULTS: Thirty participants (n = 12 in the trifarotene group and n = 18 in the VC group) (mean [standard deviation {SD}] age, 24.8 [4.7] years; 80.0% male) were interviewed. At W24, more participants in the trifarotene group (100%) than the VC group (83.3%) reported an improvement in AIH and that the change was meaningful (91.7 and 83.3%, respectively). AIH severity change (mean [SD]) from baseline to W24 was higher in the trifarotene group (-5.5 [2.5]) than the VC group (-3.5 [2.1]). More participants in the trifarotene group (≥ 90%) than in the VC group (≥ 73%) reported a meaningful improvement in their emotional functioning, personal care/hygiene, and social life/relationships. Treatment satisfaction was higher in the trifarotene group (mean [SD] = 8.6 [2.1]) than in the VC group (mean [SD] = 7.6 [3.1]).
CONCLUSION: All trifarotene-treated patients reported improvements in AIH and that their treatment expectations were met. Findings support that trifarotene plus a skincare regimen provides greater benefit in the improvement of AIH than its VC. However, VC plus a skincare regimen also appeared to improve patients' perceptions of their AIH.
OBJECTIVE AND METHODS: This was a cross-sectional, blinded, qualitative interview study embedded in the phase 4 LEAP trial (NCT05089708), which assessed the safety and efficacy of trifarotene (50 μg/g) versus its VC in the treatment of acne. The study was conducted with a subsample of participants between June and November 2022 at a subset of nine clinical sites in the United States (US). Participants were adults (18-34 years) who were randomized to receive trifarotene (50 μg/g) or VC, along with a daily skincare regimen (moisturizer, cleanser, photoprotection). After confirming participants' end-of-treatment visit during W24, telephone interviews were conducted using a semi-structured interview guide. Participants' perspectives regarding baseline AIH symptoms, changes in AIH from baseline to W24, and treatment satisfaction were assessed and analyzed using thematic analysis in ATLAS.ti to better understand trends across trial arms.
RESULTS: Thirty participants (n = 12 in the trifarotene group and n = 18 in the VC group) (mean [standard deviation {SD}] age, 24.8 [4.7] years; 80.0% male) were interviewed. At W24, more participants in the trifarotene group (100%) than the VC group (83.3%) reported an improvement in AIH and that the change was meaningful (91.7 and 83.3%, respectively). AIH severity change (mean [SD]) from baseline to W24 was higher in the trifarotene group (-5.5 [2.5]) than the VC group (-3.5 [2.1]). More participants in the trifarotene group (≥ 90%) than in the VC group (≥ 73%) reported a meaningful improvement in their emotional functioning, personal care/hygiene, and social life/relationships. Treatment satisfaction was higher in the trifarotene group (mean [SD] = 8.6 [2.1]) than in the VC group (mean [SD] = 7.6 [3.1]).
CONCLUSION: All trifarotene-treated patients reported improvements in AIH and that their treatment expectations were met. Findings support that trifarotene plus a skincare regimen provides greater benefit in the improvement of AIH than its VC. However, VC plus a skincare regimen also appeared to improve patients' perceptions of their AIH.