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Abstract <p>Acne vulgaris is one of the most common chronic inflammatory skin disorders and imposes substantial physical and psychosocial burdens. Oral isotretinoin remains the most effective monotherapy for moderate-to-severe acne, but the optimal dosing strategy for Asian patients remains unclear. Current guidelines are largely derived from Western populations, despite ethnic differences in pharmacokinetics, tolerability, and susceptibility to scarring or post-inflammatory hyperpigmentation. This systematic review and meta-analysis assessed efficacy, relapse rates, and adverse events of conventional (≥ 0.5&#xa0;mg/kg/day), low-dose (&lt; 0.5&#xa0;mg/kg/day), and intermittent (≥ 0.5&#xa0;mg/kg/day for one week per month) isotretinoin regimens in Asian populations. Following PRISMA guidelines, fourteen clinical trials involving 2,011 patients were included, and nine were eligible for meta-analysis. Efficacy was primarily measured by the mean change in Global Acne Grading System (GAGS) scores, with relapse and adverse events as secondary outcomes. Conventional dosing showed greater efficacy than low-dose regimens (MD 2.46, 95% CI − 0.18 to 5.11, <i>p</i> = 0.07) and intermittent regimens (MD 1.95, 95% CI 1.09 to 2.81, <i>p</i> &lt; 0.00001). Conventional dosing was associated with lower relapse rates than intermittent dosing (OR 0.13, 95% CI 0.05 to 0.34, <i>p</i> &lt; 0.0001), but relapse did not differ significantly between conventional and low-dose therapy (OR 1.53, 95% CI 0.54 to 4.33, <i>p</i> = 0.42). Low-dose therapy was associated with significantly lower risks of mucocutaneous adverse events, including dry eyes (RR 0.62, 95% CI 0.46 to 0.84, <i>p</i> = 0.002) and dry mouth (RR 0.28, 95% CI 0.14 to 0.58, <i>p</i> = 0.0005). Intermittent dosing had the lowest rate of cheilitis (RR 0.57, 95% CI 0.31 to 1.04, <i>p</i> = 0.07), but at the cost of reduced efficacy and higher relapse risk. Overall, conventional dosing provides the greatest efficacy but with higher toxicity, whereas low-dose regimens better balance efficacy and tolerability. Intermittent schedules may reduce adverse events but can compromise acne control. As an alternative to conventional dosing, low-dose therapy appears most practical, with intermittent dosing reserved for patients who cannot tolerate continuous treatment. These findings support individualized, ethnicity-informed prescribing to optimize acne management.</p> Protocol registered on PROSPERO <p>CRD420251074102.</p>

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Comparative efficacy and safety of isotretinoin regimens in Asian patients: a systematic review and meta-analysis

  • 期刊论文

  • 发表日期：

    2026年7月11日

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  • Lam Duc Chau,
  • Duy Nguyen,
  • Jane Nguyen,
  • Jonathan Tran Le,
  • Molynna Nguyen,
  • Huynh Wynn Tran

摘要

Abstract

Acne vulgaris is one of the most common chronic inflammatory skin disorders and imposes substantial physical and psychosocial burdens. Oral isotretinoin remains the most effective monotherapy for moderate-to-severe acne, but the optimal dosing strategy for Asian patients remains unclear. Current guidelines are largely derived from Western populations, despite ethnic differences in pharmacokinetics, tolerability, and susceptibility to scarring or post-inflammatory hyperpigmentation. This systematic review and meta-analysis assessed efficacy, relapse rates, and adverse events of conventional (≥ 0.5 mg/kg/day), low-dose (< 0.5 mg/kg/day), and intermittent (≥ 0.5 mg/kg/day for one week per month) isotretinoin regimens in Asian populations. Following PRISMA guidelines, fourteen clinical trials involving 2,011 patients were included, and nine were eligible for meta-analysis. Efficacy was primarily measured by the mean change in Global Acne Grading System (GAGS) scores, with relapse and adverse events as secondary outcomes. Conventional dosing showed greater efficacy than low-dose regimens (MD 2.46, 95% CI − 0.18 to 5.11, p = 0.07) and intermittent regimens (MD 1.95, 95% CI 1.09 to 2.81, p < 0.00001). Conventional dosing was associated with lower relapse rates than intermittent dosing (OR 0.13, 95% CI 0.05 to 0.34, p < 0.0001), but relapse did not differ significantly between conventional and low-dose therapy (OR 1.53, 95% CI 0.54 to 4.33, p = 0.42). Low-dose therapy was associated with significantly lower risks of mucocutaneous adverse events, including dry eyes (RR 0.62, 95% CI 0.46 to 0.84, p = 0.002) and dry mouth (RR 0.28, 95% CI 0.14 to 0.58, p = 0.0005). Intermittent dosing had the lowest rate of cheilitis (RR 0.57, 95% CI 0.31 to 1.04, p = 0.07), but at the cost of reduced efficacy and higher relapse risk. Overall, conventional dosing provides the greatest efficacy but with higher toxicity, whereas low-dose regimens better balance efficacy and tolerability. Intermittent schedules may reduce adverse events but can compromise acne control. As an alternative to conventional dosing, low-dose therapy appears most practical, with intermittent dosing reserved for patients who cannot tolerate continuous treatment. These findings support individualized, ethnicity-informed prescribing to optimize acne management.

Protocol registered on PROSPERO

CRD420251074102.