Melvin Bae, Jürgen Lademann, Martina C. Meinke, Björn Meder, Christoph Geilen
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Both groups self-applied 0.1% of adapalene cream daily and received weekly skin-cleansing by a physician combined with either CAP verum-device treatments or placebo-device applications instead. The endpoint of the treatment segment was at 6, and follow-up was at 10 weeks. The co-primary endpoints total inflammatory lesion count (TILC) and acne-specific Investigator Global Assessment (IGA) score as well as secondary endpoints sebumetry, total porphyrin count (TPC) reflecting <i>Cutibacterium acnes</i> colonization, and occurrence of adverse events (AEs) were measured from baseline until follow-up, while the Acne-specific Quality of Life (AQOL) questionnaire was assessed at baseline and endpoint. TILC decreased greater in the verum versus control group from baseline (45.8 vs. 49.4) toward endpoint (22.1 vs. 38.6; <i>p</i> = 0.07) to follow-up (16.5 vs. 28.7; <i>p</i> = 0.48), matched by the IGA score with similarly greater improvement in the verum versus control group from baseline (2.3 vs. 2.6) to endpoint (1.3 vs. 2.3; <i>p</i> < 0.001) until follow-up (1.0 vs. 1.9; <i>p</i> = 0.006). Sebumetry, TPC, and AQOL scores decreased more during treatment and in the verum group. AE occurred less frequently in the verum group without serious AE reported overall (all <i>p</i> < 0.05). 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The co-primary endpoints total inflammatory lesion count (TILC) and acne-specific Investigator Global Assessment (IGA) score as well as secondary endpoints sebumetry, total porphyrin count (TPC) reflecting <i>Cutibacterium acnes</i> colonization, and occurrence of adverse events (AEs) were measured from baseline until follow-up, while the Acne-specific Quality of Life (AQOL) questionnaire was assessed at baseline and endpoint. TILC decreased greater in the verum versus control group from baseline (45.8 vs. 49.4) toward endpoint (22.1 vs. 38.6; <i>p</i> = 0.07) to follow-up (16.5 vs. 28.7; <i>p</i> = 0.48), matched by the IGA score with similarly greater improvement in the verum versus control group from baseline (2.3 vs. 2.6) to endpoint (1.3 vs. 2.3; <i>p</i> < 0.001) until follow-up (1.0 vs. 1.9; <i>p</i> = 0.006). Sebumetry, TPC, and AQOL scores decreased more during treatment and in the verum group. 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引用次数: 0
摘要
痤疮是世界范围内的一种常见疾病,主要发生在青少年中。常用的处方疗法往往会引起不良反应,如果使用抗生素,则有产生耐药性的风险。冷大气等离子体(CAP)是一种耐受性良好的物理治疗方法,由于它具有杀菌和伤口愈合的特性,因此在慢性伤口治疗中得到了很好的应用。我们的目的是在一项随机对照、双盲先导研究中评估CAP作为轻度丘疹性痤疮的潜在附加疗法的有效性和安全性。40名参与者被随机分为两组,每组20人。两组患者每天自行使用0.1%的阿达帕林乳霜,每周由医生进行皮肤清洁,同时使用CAP veral装置治疗或安慰剂装置治疗。治疗期的终点为6周,随访时间为10周。从基线到随访期间测量共同主要终点总炎症病灶计数(TILC)和痤疮特异性研究者总体评估(IGA)评分,以及次要终点皮脂测定、反映痤疮表皮杆菌定植的总卟啉计数(TPC)和不良事件(ae)的发生,同时在基线和终点评估痤疮特异性生活质量(akol)问卷。verum组的TILC从基线(45.8比49.4)到终点(22.1比38.6;P = 0.07)至随访(16.5 vs. 28.7;p = 0.48),与IGA评分相匹配,verum组与对照组相比,从基线(2.3 vs 2.6)到终点(1.3 vs 2.3;p & lt;0.001),直到随访(1.0 vs. 1.9;P = 0.006)。皮脂测量、TPC和aol评分在治疗期间和verum组下降更多。总体而言,无严重AE报告的verum组发生AE的频率较低(p <;0.05)。最后,CAP被证明是治疗轻度丘疹性痤疮的一种有效且耐受性良好的附加疗法。试验注册:德国临床试验注册中心:DRKS00032416
Therapeutic Use of Cold Atmospheric Plasma for the Treatment of Mild Acne Papulopustulosa—A Randomized, Controlled, Double-Blind Pilot Study
Acne is a common disease worldwide, predominantly occurring in teenagers. Commonly prescribed therapies often cause adverse effects and in case of antibiotics bare the risk of developing resistances. Cold atmospheric plasma (CAP) is a well-tolerable, physical treatment method, which is well established in the treatment of chronic wounds since it provides bactericidal and wound healing properties. Our aim was to evaluate the efficacy and safety of CAP as a potential add-on therapy for mild acne papulopustulosa in a randomized controlled, double-blind pilot study. Forty participants were randomized into two arms of 20 each. Both groups self-applied 0.1% of adapalene cream daily and received weekly skin-cleansing by a physician combined with either CAP verum-device treatments or placebo-device applications instead. The endpoint of the treatment segment was at 6, and follow-up was at 10 weeks. The co-primary endpoints total inflammatory lesion count (TILC) and acne-specific Investigator Global Assessment (IGA) score as well as secondary endpoints sebumetry, total porphyrin count (TPC) reflecting Cutibacterium acnes colonization, and occurrence of adverse events (AEs) were measured from baseline until follow-up, while the Acne-specific Quality of Life (AQOL) questionnaire was assessed at baseline and endpoint. TILC decreased greater in the verum versus control group from baseline (45.8 vs. 49.4) toward endpoint (22.1 vs. 38.6; p = 0.07) to follow-up (16.5 vs. 28.7; p = 0.48), matched by the IGA score with similarly greater improvement in the verum versus control group from baseline (2.3 vs. 2.6) to endpoint (1.3 vs. 2.3; p < 0.001) until follow-up (1.0 vs. 1.9; p = 0.006). Sebumetry, TPC, and AQOL scores decreased more during treatment and in the verum group. AE occurred less frequently in the verum group without serious AE reported overall (all p < 0.05). Conclusively, CAP proved to be an efficient and well-tolerable add-on therapy for the treatment of mild acne papulopustulosa.
Trial Registration: German Registry of Clinical Trials: DRKS00032416
期刊介绍:
Dermatologic Therapy has been created to fill an important void in the dermatologic literature: the lack of a readily available source of up-to-date information on the treatment of specific cutaneous diseases and the practical application of specific treatment modalities. Each issue of the journal consists of a series of scholarly review articles written by leaders in dermatology in which they describe, in very specific terms, how they treat particular cutaneous diseases and how they use specific therapeutic agents. The information contained in each issue is so practical and detailed that the reader should be able to directly apply various treatment approaches to daily clinical situations. Because of the specific and practical nature of this publication, Dermatologic Therapy not only serves as a readily available resource for the day-to-day treatment of patients, but also as an evolving therapeutic textbook for the treatment of dermatologic diseases.