Scholarlink

<p>Papulopustular rosacea (PPR) is a chronic inflammatory skin disorder with limited systemic treatments. Doxycycline 40&#xa0;mg is the only FDA-approved oral therapy, but efficacy varies. DFD-29, a novel extended-release minocycline 40&#xa0;mg, has shown superior efficacy in recent head-to-head trials. This meta-analysis compares the efficacy and safety of DFD-29 and doxycycline 40&#xa0;mg in moderate-to-severe PPR.</p><p>We systematically searched PubMed, the Cochrane Library, and ClinicalTrials.gov up to July 2025 for randomized controlled trials (RCTs) directly comparing DFD-29 (40&#xa0;mg) with doxycycline (40&#xa0;mg) in patients with moderate-to-severe papulopustular rosacea (PPR). The primary efficacy outcome was Investigator’s Global Assessment (IGA) success at week 16, defined as a score of 0 (clear) or 1 (almost clear) with at least a two-grade improvement from baseline. Safety outcomes included treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and specific adverse events such as diarrhea, vertigo, and headache. Data were pooled using random-effects models, and statistical heterogeneity was assessed using the I² statistic. All analyses were conducted using Python programming language (version 3.11.13).</p><p>Three head-to-head randomized controlled trials (MVOR-1, MVOR-2, and Tsianakas 2021; total <i>N</i> = 593) met the inclusion criteria. Pooled analysis demonstrated that DFD-29 was associated with significantly higher Investigator’s Global Assessment (IGA) success rates compared to doxycycline (odds ratio [OR]: 2.86; 95% confidence interval [CI] 2–4.08; <i>p</i> &lt; 0.001), with low heterogeneity. Safety outcomes were comparable between groups, with no statistically significant differences observed in treatment-emergent adverse events (TEAEs) (OR: 1.28; 95% CI 0.89–1.83), serious adverse events (SAEs) (OR: 1.06; 95% CI 0.22–5.07), diarrhea (OR: 1.28; 95% CI 0.44–3.74), vertigo (OR: 1.00; 95% CI 0.20–4.89), or headache (OR: 0.83; 95% CI 0.33–2.08). Heterogeneity for safety outcomes was negligible.</p><p>DFD-29 (40&#xa0;mg) demonstrates significantly greater efficacy than doxycycline (40&#xa0;mg) in the treatment of moderate-to-severe papulopustular rosacea, while maintaining a comparable safety and tolerability profile. However, these findings should be interpreted cautiously given the limited number and duration of trials. Further long-term and large-scale studies are warranted to assess durability of response, effectiveness in diverse patient populations and rare adverse effects such as hypersensitivity reactions.</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

Efficacy and safety of low-dose minocycline (DFD-29) versus doxycycline in papulopustular rosacea: a systematic review and meta-analysis

  • 期刊论文

  • 发表日期：

    2025年12月9日

查看全文
  • Alhasan Altayf,
  • Samar Abujami

摘要

Papulopustular rosacea (PPR) is a chronic inflammatory skin disorder with limited systemic treatments. Doxycycline 40 mg is the only FDA-approved oral therapy, but efficacy varies. DFD-29, a novel extended-release minocycline 40 mg, has shown superior efficacy in recent head-to-head trials. This meta-analysis compares the efficacy and safety of DFD-29 and doxycycline 40 mg in moderate-to-severe PPR.

We systematically searched PubMed, the Cochrane Library, and ClinicalTrials.gov up to July 2025 for randomized controlled trials (RCTs) directly comparing DFD-29 (40 mg) with doxycycline (40 mg) in patients with moderate-to-severe papulopustular rosacea (PPR). The primary efficacy outcome was Investigator’s Global Assessment (IGA) success at week 16, defined as a score of 0 (clear) or 1 (almost clear) with at least a two-grade improvement from baseline. Safety outcomes included treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and specific adverse events such as diarrhea, vertigo, and headache. Data were pooled using random-effects models, and statistical heterogeneity was assessed using the I² statistic. All analyses were conducted using Python programming language (version 3.11.13).

Three head-to-head randomized controlled trials (MVOR-1, MVOR-2, and Tsianakas 2021; total N = 593) met the inclusion criteria. Pooled analysis demonstrated that DFD-29 was associated with significantly higher Investigator’s Global Assessment (IGA) success rates compared to doxycycline (odds ratio [OR]: 2.86; 95% confidence interval [CI] 2–4.08; p < 0.001), with low heterogeneity. Safety outcomes were comparable between groups, with no statistically significant differences observed in treatment-emergent adverse events (TEAEs) (OR: 1.28; 95% CI 0.89–1.83), serious adverse events (SAEs) (OR: 1.06; 95% CI 0.22–5.07), diarrhea (OR: 1.28; 95% CI 0.44–3.74), vertigo (OR: 1.00; 95% CI 0.20–4.89), or headache (OR: 0.83; 95% CI 0.33–2.08). Heterogeneity for safety outcomes was negligible.

DFD-29 (40 mg) demonstrates significantly greater efficacy than doxycycline (40 mg) in the treatment of moderate-to-severe papulopustular rosacea, while maintaining a comparable safety and tolerability profile. However, these findings should be interpreted cautiously given the limited number and duration of trials. Further long-term and large-scale studies are warranted to assess durability of response, effectiveness in diverse patient populations and rare adverse effects such as hypersensitivity reactions.