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.

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Diagnostic test: assess the possible role of Salicylic acid, Isotretinoin, and N-acetylcysteine in improving the susceptibility of C. acne for Azithromycin and Doxycycline.

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 48

Contacts and Locations

Study Locations

• Egypt
  • Al Sharqia
    • Zagazig, Al Sharqia, Egypt, 2543
      • Reham Essam

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

The study was carried out on 48 patients with acne vulgaris

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

study group

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
inhibition of biofilm formation of c.acne after the use of Salicylic acid, Isotretinoin, and N-acetylcysteine	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	6 month
improvement of antibiotic sensitivity of c.acne after the use of Salicylic acid, Isotretinoin, and N-acetylcysteine	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	6 month

Collaborators and Investigators

• Sponsor: Zagazig University
• Investigators: Principal Investigator: Reham Essam, Zagazig University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Actual): February 1, 2024
• Study Completion (Actual): February 1, 2024

Study Registration Dates

• First Submitted: November 26, 2023
• First Submitted That Met QC Criteria: December 18, 2023
• First Posted (Actual): December 21, 2023

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 21, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Peripheral Nervous System Agents; Antiviral Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Protective Agents; Dermatologic Agents; Anti-Bacterial Agents; Respiratory System Agents; Antifungal Agents; Keratolytic Agents; Antiprotozoal Agents; Antiparasitic Agents; Antioxidants; Antidotes; Free Radical Scavengers; Antimalarials; Expectorants; Doxycycline; Salicylic Acid; Acetylcysteine; N-monoacetylcystine; Azithromycin; Isotretinoin; Salicylates
• Other Study ID Numbers: 10156 IRB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No