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

Acne Vulgaris Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06179056
• Other study ID #: 10156 IRB
• Status: Completed
• Start date: March 1, 2023
• Est. completion date: February 1, 2024

Study information

• Verified date: April 2024
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

• 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: February 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

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

Locations

Country	Name	City	State
Egypt	Reham Essam	Zagazig	Al Sharqia

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 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
Primary	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