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临床试验/NCT06179056
NCT06179056已完成不适用

Anti-microbial Role of Non-antibiotic Agents Against Cutibacterium Acnes in Patients With Acne Vulgaris

Zagazig University1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2023年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
48
试验地点
1
主要终点
inhibition of biofilm formation of c.acne after the use of Salicylic acid, Isotretinoin, and N-acetylcysteine

研究概览

简要总结

  • To evaluate and compare the anti-biofilm activity of Salicylic acid, Isotretinoin, and N-acetylcysteine against C. acne .
  • To assess the possible role of Salicylic acid, Isotretinoin, and N-acetylcysteine in improving the susceptibility of C. acne for Azithromycin and Doxycycline.

详细描述

The study was carried out on 24 patients with acne vulgaris. They were recruited from the outpatient clinic of the Dermatology and Venereology and Andrology Department, Zagazig University Hospitals, Egypt.

The degree of severity of lesions was determined by the global acne grading system (GAGS)

Microbiological samples were collected from all patients for:

  1. Isolation of C. acnes
  2. Antibiotic susceptibility testing for C. acnes isolates aganist the most commonly used antibiotics in treatment of acne(Azithromycin and Doxycycline) in the presence and absence of Salicylic acid, Isotretinoin, and N-acetylcysteine
  3. Testing biofilm forming ability of C. acnes isolates in the presence and absence of Salicylic acid, Isotretinoin, and N-acetylcysteine

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
16 Years 至 40 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Adult Patients.
  • Patients of both sexes.
  • Patients with acne vulgaris with different grades

排除标准

  • Patients received topical or oral treatment within 6 weeks prior to microbiological sampling

结局指标

主要结局

inhibition of biofilm formation of c.acne after the use of Salicylic acid, Isotretinoin, and N-acetylcysteine

时间窗: 6 month

Biofilm forming ability of P. acnes isolates was adapted from Coenye et al., 2007 and Abbott et al., 2022 G. The results were obtained according to (Stepanovic et al., 2007); the average OD values were calculated for all tested isolates \& negative controls, and the cut-off value (ODc) was detected. It is defined as a 3 standard deviation (SD) above the mean OD of the negative control. The final OD value of a tested strain was expressed as the average OD value of the strain reduced by ODc value; ODc value was calculated for each plate separately. For easier interpretation of the results, strains were divided into the following categories: * Non-biofilm producer = OD ≤ODc * Strong biofilm producer = 4×ODc \<OD Growth in the presence of the following agents was tested (all percentages are w/v): 2% salicylic acid, 5% acetylcysteine, and 0.05% isotretinoin

improvement of antibiotic sensitivity of c.acne after the use of Salicylic acid, Isotretinoin, and N-acetylcysteine

时间窗: 6 month

All strains were tested for antibiotic susceptibility to azithromycin and doxycycline The minimal inhibitory concentration (MIC) was evaluated by the broth microdilution method according to CLSI (2012). The minimal bactericidal concentration (MBC) was evaluated by using a modified flash microbicide method (Hernandes et al., 2013). The MICs of the tested antimicrobial agents were determined by the broth microdilution method according to CLSI (2012) as above in the presence of 2% salicylic acid, 5% acetylcysteine and 0.05% isotretinoin

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Reham Essam

Lecturer of Dermatology

Zagazig University

研究点 (1)

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