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Completed

NCT Number: NCT06179056

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

* 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.

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Key information

Age range

16 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Reham Essam

Zagazig, Al Sharqia, 2543, Egypt

About this study

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:

  • Isolation of C. acnes
  • 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
  • Testing biofilm forming ability of C. acnes isolates in the presence and absence of Salicylic acid, Isotretinoin, and N-acetylcysteine

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

assess the possible role of Salicylic acid, Isotretinoin, and N-acetylcysteine in improving the susceptibility of C. acne for Azithromycin and Doxycycline.

Diagnostic Test

Microbiological samples were collected from all patients for:

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

Primary outcomes

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

    Time frame: 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

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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 21, 2023
Registry last updated
Apr 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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