Draelos Zoe Diana, Gunt Hemali, Levy Stanley B.
J Drugs Dermatol. 2019 Feb 1;18(2):141-146.
Background: Rosacea is characterized by irritation associated with erythema, telangiectasias and papules/pustules. Whole formula nature-based sensitive skin products are formulated to maintain skin barrier and appropriate hydration that can lead to soothing benefits. Objective: To evaluate the efficacy and tolerability of a regimen consisting of a cleanser containing natural oils, beeswax, and witch hazel and day and night creams containing natural oils, glycerin, and botanical anti-inflammatories (NR); and a synthetic dermatologist-recommended regimen of cetyl alcohol, sodium lauryl sulphate-containing cleanser, and glycerin, polyisobutene-containing lotion (CR) in subjects with rosacea. Methods: 80 female subjects with rosacea who received 6 weeks of 0.75% metronidazole gel, were randomized to receive NR or CR, twice daily, for 4 weeks in conjunction with the gel. Blinded investigator global assessment of rosacea, investigator-rated, and subject-rated overall skin appearance was assessed using a 5-point scale (0=none, 4=severe) at baseline, 2 weeks, and 4 weeks. Noninvasive skin assessments for skin hydration and skin barrier function were made by corneometry and TEWL, respectively. Results: NR resulted in improvement in investigator global assessment of rosacea measures at 4 weeks from baseline (erythema, 28%; telangiectasia, 26%; papules/pustules, 34%: P<0.001) and CR resulted in a 8 to 12% improvement. Differences between treatments were statistically significant. Overall skin appearance measured by the investigator was clinically and statistically improved from baseline by 32% and 12% with NR and CR, respectively. Overall skin appearance measured by subjects was improved by both NR and CR from baseline with no differences between treatments. Both regimens improved barrier function from baseline to week 4 (13%, NR; 14%, CR). NR decreased hydration by 21% from baseline at week 4 while CR increased hydration by 14% (P<0.001 from NR). No clinically significant tolerability issues were reported in either regimen at week 4. Conclusion: NR was effective, well tolerated, and superior to CR in the management of rosacea, concomitantly treated with metronidazole. National Clinical Trial Identifier: NCT03392558 J Drugs Dermatol. 2019;18(2):141-146.
酒渣鼻的特征是伴有红斑、毛细血管扩张和丘疹/脓疱的皮肤刺激。全配方天然敏感肌产品旨在维持皮肤屏障和适当的水合作用，从而带来舒缓效果。目的：评估一种治疗方案的疗效和耐受性，该方案包括一款含有天然油、蜂蜡和金缕梅的洁面产品以及含有天然油、甘油和植物抗炎成分的日霜和晚霜（NR）；以及一种皮肤科医生推荐的合成治疗方案，包括十六醇、含月桂醇硫酸酯钠的洁面产品，以及含有甘油、聚异丁烯的乳液（CR），用于酒渣鼻患者。方法：80名接受了6周0.75%甲硝唑凝胶治疗的酒渣鼻女性受试者，被随机分为两组，分别接受NR或CR治疗，每日两次，为期4周，同时继续使用凝胶。在基线、2周和4周时，采用5分制量表（0 = 无，4 = 严重）对酒渣鼻进行盲法研究者整体评估、研究者评分和受试者评分的整体皮肤外观评估。分别通过角质层水合测量仪和经皮水分流失对皮肤水合作用和皮肤屏障功能进行无创皮肤评估。结果：与基线相比，NR组在4周时酒渣鼻的研究者整体评估指标有所改善（红斑改善28%；毛细血管扩张改善26%；丘疹/脓疱改善34%：P < 0.001），CR组改善了8%至12%。治疗组之间的差异具有统计学意义。研究者评估的整体皮肤外观，NR组和CR组分别较基线有32%和12%的临床和统计学改善。受试者评估的整体皮肤外观，NR组和CR组均较基线有所改善，治疗组之间无差异。两种治疗方案从基线到第4周均改善了屏障功能（NR组改善13%；CR组改善14%）。NR组在第4周时水合作用较基线下降了21%，而CR组水合作用增加了14%（与NR组相比P < 0.001）。在第4周时，两种治疗方案均未报告有临床意义的耐受性问题。结论：在与甲硝唑联合治疗酒渣鼻时，NR有效、耐受性良好且优于CR。国家临床试验标识符：NCT03392558《皮肤药物学杂志》。2019年；18(2):14-146。
