A Dermocosmetic Balm Containing Vitamin B5, Madecassoside, and a Prebiotic Complex Significantly Improves Post Fractionated CO2 Laser Downtime Versus a Repairing Skin Care: Results of a Randomized Double Blind Intra-Individual Exploratory Study

IF 2.5 4区 医学 Q2 DERMATOLOGY Journal of Cosmetic Dermatology Pub Date : 2024-10-03 DOI:10.1111/jocd.16610
Jean-Michel Amici, Guénaelle Le Dantec, Ann' Laure Demessant, Catherine Queille-Roussel, Magali Procacci Babled, Anne Claire Cathelineau, Alix Danoy, Solene Trevisan, Merete Haedersdal
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Therefore, experts recommend appropriate post CO<sub>2</sub> laser skin care using dermocosmetics (DC) to restore the skin barrier integrity and to improve physical cutaneous signs [<span>3, 4</span>].</p><p>With this double-blind, randomized intra-individual study, we evaluated the skin re-epithelization kinetics and barrier-associated clinical signs and symptoms management with DC balm (Cicaplast® Baume B5+, La Roche-Posay Laboratoire Dermatologique, France) containing vitamin B5, madecassoside, and a prebiotic complex including inactivated <i>Lactobacillus</i> spp. ferments, oligosaccharides, mannose, and <i>Aqua posae filiformis</i> <i>versus</i> a repairing DC (RDC) cream featuring thermal spring water, <i>Aquaphilus dolomiae</i> ferment filtrate, and purifying actives following Fx CO<sub>2</sub> laser (LaserPulse®, Luminenis Ltd., France).</p><p>We included 25 adults, 15 women and 10 men, with a mean age of 37.7 ± 7.3 years and a Phototype II (3;12%) or III (22;88%). Clinical assessments comprised the assessment of the wound healing kinetic overtime based on re-epithelization of the lesional area, the wound healing score (0 = none to 5 = complete healing), individual scores of erythema, desquamation and crusts (from 0 = none to 3 = severe) as well as their composite score (0–9). Moreover, the investigator assessed the skin color (ITA, individual typology angle) using a colorimeter (CL400 (E®), Courage &amp; Khazaka, Germany) and took photos using SkinTone technologies (Newtone Technologies, France). The area under the curve (AUC) was calculated for the wound healing score and ITA values.</p><p>The mean complete healing kinetic was achieved significantly (<i>p</i> = 0.003) faster with DC balm (13.5 ± 3.1 days) than with RDC (15.8 ± 2.3 days); the mean LS difference was 2.771 days (CI 95%: 0.741; 4.801). The mean wound healing score (Figure 1) was significantly (<i>p</i> &lt; 0.05) higher with DC balm compared to RDC between Day 6 and 10 and at Days 13 and 14 confirming a faster lesion healing with DC balm. At Day 17, 14 areas treated with DC balm compared to 10 treated with RDC were completely healed.</p><p>Furthermore, both the composite and crust scores had significantly (<i>p</i> &lt; 0.05) faster and better improved compared to the RDC-treated area between Day 6 and 10 as well as on Day 14. Nevertheless, we did not observe any significant differences between both products for the improvement of erythema and desquamation.</p><p>Finally, the AUC of the wound healing score was 44.9 ± 10.05 n/N (10.1%) for DC balm and 36.18 n/N (10.7%) for RDC. The difference was significantly (<i>p</i> &lt; 0.01) in favor of DC balm (LS means: −8.72, CI 95%: −13.67; −3.74). 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引用次数: 0

Abstract

Ablative fractional (Fx) CO2 skin resurfacing laser can reduce scars and alleviate aging signs by removing the superficial epidermal layers [1, 2]. However, temporary but bothersome side effects such as erythema, desquamation, and crusts may occur with a frequency and severity depending on laser settings which may impact the patient's quality of life (QoL) [2]. Therefore, experts recommend appropriate post CO2 laser skin care using dermocosmetics (DC) to restore the skin barrier integrity and to improve physical cutaneous signs [3, 4].

With this double-blind, randomized intra-individual study, we evaluated the skin re-epithelization kinetics and barrier-associated clinical signs and symptoms management with DC balm (Cicaplast® Baume B5+, La Roche-Posay Laboratoire Dermatologique, France) containing vitamin B5, madecassoside, and a prebiotic complex including inactivated Lactobacillus spp. ferments, oligosaccharides, mannose, and Aqua posae filiformis versus a repairing DC (RDC) cream featuring thermal spring water, Aquaphilus dolomiae ferment filtrate, and purifying actives following Fx CO2 laser (LaserPulse®, Luminenis Ltd., France).

We included 25 adults, 15 women and 10 men, with a mean age of 37.7 ± 7.3 years and a Phototype II (3;12%) or III (22;88%). Clinical assessments comprised the assessment of the wound healing kinetic overtime based on re-epithelization of the lesional area, the wound healing score (0 = none to 5 = complete healing), individual scores of erythema, desquamation and crusts (from 0 = none to 3 = severe) as well as their composite score (0–9). Moreover, the investigator assessed the skin color (ITA, individual typology angle) using a colorimeter (CL400 (E®), Courage & Khazaka, Germany) and took photos using SkinTone technologies (Newtone Technologies, France). The area under the curve (AUC) was calculated for the wound healing score and ITA values.

The mean complete healing kinetic was achieved significantly (p = 0.003) faster with DC balm (13.5 ± 3.1 days) than with RDC (15.8 ± 2.3 days); the mean LS difference was 2.771 days (CI 95%: 0.741; 4.801). The mean wound healing score (Figure 1) was significantly (p < 0.05) higher with DC balm compared to RDC between Day 6 and 10 and at Days 13 and 14 confirming a faster lesion healing with DC balm. At Day 17, 14 areas treated with DC balm compared to 10 treated with RDC were completely healed.

Furthermore, both the composite and crust scores had significantly (p < 0.05) faster and better improved compared to the RDC-treated area between Day 6 and 10 as well as on Day 14. Nevertheless, we did not observe any significant differences between both products for the improvement of erythema and desquamation.

Finally, the AUC of the wound healing score was 44.9 ± 10.05 n/N (10.1%) for DC balm and 36.18 n/N (10.7%) for RDC. The difference was significantly (p < 0.01) in favor of DC balm (LS means: −8.72, CI 95%: −13.67; −3.74). The AUC for ITA was also significantly (p < 0.001; LS means: −136.79, CI 95%: −215.02; −58.56) in favor of DC balm 541.7 n/N (175.0%) over RDC 404.9 n/N (254.6%).

Figure 2 provides an example comparing the re-epithelization of two zones treated with either DC balm or RDC.

In conclusion, this study demonstrated that a daily use of DC balm post-Fx CO2 laser resulted in a significantly faster and better skin repair, especially during the first 14 days of application potentially improving the patients' QoL during this critical period. Moreover it significantly reduced crust formation and limited skin discoloration compared to RDC. The herewith presented exploratory results require confirmation through a large randomized study assessing not only the clinical benefits of the tested products but also the patients' quality of life status post-laser.

C.Q.R. performed the study, G.L.D. and A.L.D. supervised the study, all authors analyzed the data. G.L.D. and A.L.D. wrote, and all authors read and approved the manuscript.

This single center, intra-individual, randomized study adhered to the principles of Good Clinical Practices and the declaration of Helsinki. According to French regulatory guidelines, this type of trial received ethics committee approval (Comité Ethique Nord-Ouest I on September 8, 2022, approval number 2022-A01037-36). All subjects provided written informed consent prior to their participation.

Guénaelle Le Dantec and Ann'Laure Demessant are employees of La Roche-Posay Laboratoire Dermatologique.

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含有维生素 B5、麦地卡索苷和益生菌复合物的皮肤美容膏与修复护肤品相比,能显著改善二氧化碳分段激光术后的停工期:随机双盲个体内探索性研究结果。
烧蚀分数(Fx) CO2激光皮肤表面修复术通过去除表皮浅层来减少疤痕,缓解衰老迹象[1,2]。然而,根据激光的设置,可能会出现短暂但令人烦恼的副作用,如红斑、脱屑和结痂,其频率和严重程度可能会影响患者的生活质量(QoL)[2]。因此,专家建议在CO2激光后使用dermocosmetics (DC)进行适当的皮肤护理,以恢复皮肤屏障的完整性并改善皮肤体征[3,4]。在这项双盲、随机的个体内研究中,我们评估了含有维生素B5、马齿皂苷和益生元复合物(包括灭活的乳酸杆菌、酵母菌、低聚糖、甘露糖和水草)的DC软膏(Cicaplast®Baume B5+, La Roche-Posay Laboratoire Dermatologique,法国)与含有温泉水的修复DC (RDC)软膏的皮肤再表皮化动力学和屏障相关临床体征和症状管理。采用Fx CO2激光(LaserPulse®,Luminenis Ltd,法国)对水藻发酵滤液和纯化活性进行检测。我们纳入了25名成人,15名女性和10名男性,平均年龄37.7±7.3岁,Phototype II(3.12%)或Phototype III(22.88%)。临床评估包括基于病灶区再上皮化的伤口愈合动力学的评估、伤口愈合评分(0 =无至5 =完全愈合)、红斑、脱屑和结痂的单项评分(0 =无至3 =严重)及其综合评分(0 - 9)。此外,研究者使用色度计(CL400 (E®)、Courage &;kazaka,德国),并使用SkinTone技术(Newtone technologies,法国)拍照。曲线下面积(AUC)计算伤口愈合评分和ITA值。DC软膏(13.5±3.1 d)比RDC(15.8±2.3 d)更快达到平均完全愈合动力学(p = 0.003);平均LS差为2.771天(CI 95%: 0.741;4.801)。在第6天至第10天以及第13天至第14天,与RDC相比,DC香膏的平均伤口愈合评分(图1)显著(p < 0.05)更高,证实DC香膏的伤口愈合更快。在第17天,用DC软膏治疗的14个区域与用RDC治疗的10个区域完全愈合。此外,在第6天至第10天以及第14天,与rdc处理区相比,复合评分和结皮评分均有显著(p < 0.05)更快、更好的改善。然而,我们没有观察到两种产品在改善红斑和脱屑方面有任何显著差异。伤口愈合评分的AUC分别为:DC药膏44.9±10.05 n/ n(10.1%)和RDC药膏36.18 n/ n(10.7%)。差异有统计学意义(p < 0.01),有利于DC香脂(LS均值:−8.72,CI 95%:−13.67;−3.74)。ITA的AUC也显著高于(p < 0.001;LS均值:−136.79,CI 95%:−215.02;−58.56),直流香脂541.7 n/ n(175.0%)优于RDC 404.9 n/ n(254.6%)。图2提供了一个比较用DC香膏或RDC处理的两个区域的再上皮化的例子。总之,本研究表明,在fx CO2激光治疗后,每天使用DC香脂可显著提高皮肤修复速度和效果,尤其是在使用后的前14天,可能会改善患者在这一关键时期的生活质量。此外,与RDC相比,它显著减少了结皮的形成,限制了皮肤变色。本文提出的探索性结果需要通过一项大型随机研究来证实,不仅要评估测试产品的临床益处,还要评估激光c.q.r后患者的生活质量状况。执行这项研究,gld和A.L.D.监督这项研究,所有作者都分析了数据。g.l.d和a.l.d负责撰写,所有作者都阅读并批准了稿件。这项单中心、个体内、随机研究遵循良好临床实践和赫尔辛基宣言的原则。根据法国监管指南,该类型的试验获得了伦理委员会的批准(comit Ethique Nord-Ouest I于2022年9月8日批准,批准号2022- a01037 -36)。所有受试者在参与前均提供书面知情同意书。gusamnaelle Le Dantec和Ann'Laure Demessant是罗氏皮肤实验室的员工。
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来源期刊
CiteScore
4.30
自引率
13.00%
发文量
818
审稿时长
>12 weeks
期刊介绍: The Journal of Cosmetic Dermatology publishes high quality, peer-reviewed articles on all aspects of cosmetic dermatology with the aim to foster the highest standards of patient care in cosmetic dermatology. Published quarterly, the Journal of Cosmetic Dermatology facilitates continuing professional development and provides a forum for the exchange of scientific research and innovative techniques. The scope of coverage includes, but will not be limited to: healthy skin; skin maintenance; ageing skin; photodamage and photoprotection; rejuvenation; biochemistry, endocrinology and neuroimmunology of healthy skin; imaging; skin measurement; quality of life; skin types; sensitive skin; rosacea and acne; sebum; sweat; fat; phlebology; hair conservation, restoration and removal; nails and nail surgery; pigment; psychological and medicolegal issues; retinoids; cosmetic chemistry; dermopharmacy; cosmeceuticals; toiletries; striae; cellulite; cosmetic dermatological surgery; blepharoplasty; liposuction; surgical complications; botulinum; fillers, peels and dermabrasion; local and tumescent anaesthesia; electrosurgery; lasers, including laser physics, laser research and safety, vascular lasers, pigment lasers, hair removal lasers, tattoo removal lasers, resurfacing lasers, dermal remodelling lasers and laser complications.
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