Comparing Efficacy of Azithromycin and Probiotics for Treatment of Acne Vulgaris

Acne Vulgaris Clinical Trial

Official title:

Comparing Efficacy of Azithromycin and Probiotics for Treatment of Acne Vulgaris

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05629468
• Other study ID #: A/28/EC/337/2021
• Status: Completed
• Phase: Phase 3
• Start date: October 15, 2021
• Est. completion date: August 31, 2022

Study information

• Verified date: November 2022
• Source: Pak Emirates Military Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

the goal of this clinical trial is to measure the efficacy of probiotics for treatment of acne vulgaris, to compare it with azithromycin and to measure the synergistic effect of azithromycin and probiotics for treatment of acne vulgaris

Description:

this study aims to answer this research question: in patients of acne vulgaris, is use of probiotics as efficacious as azithromycin in treating acne lesions & improving quality of life? total 75 patients were divided into 3 groups. group A received azithromycin, group B received probiotics and group C received both drugs. a topical cream was also advised to all groups. outcome was measured as reduction in total lesion count and improvement in patients' quality of life via reduction in Dermatology Life Quality Index score.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: August 31, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 35 Years

Eligibility

Inclusion Criteria:

• Diagnosed Patients of Mild and Moderate acne

• Aged between 15 and 35 years

Exclusion Criteria:

• Severe acne or any systemic inflammatory disease

• Other oral treatment for acne

• Allergic to any drug being used in the study

• Pregnancy

• PCOs

• Any drug which can interact with azithromycin

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• Azithromycin
antibiotic
• Probiotic Formula
probiotics
• Benzoyl Peroxide 4 % Topical Cream
topical cream

Locations

Country	Name	City	State
Pakistan	PEMH	Rawalpindi	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Pak Emirates Military Hospital

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change or reduction in the Total Lesion Count	number of acne lesions are counted at every follow up to see whether lesions are reduced than the baseline or not	at start of the study (baseline), 2 weeks (1st follow up visit), 4 weeks (2nd follow up visit), 8 weeks (3rd follow up visit) and 12 weeks (4th follow up visit).
Secondary	change or reduction in the Dermatology Life Quality Index score	improvement in patients' quality of life was assessed to see whether the score has been reduced than the baseline score or not. it was assessed by a 10-item self assessment questionnaire i.e Dermatology Life Quality Index. the score ranges between 0 to 30. higher score means worst outcome and the lower score means better outcome.	at start of the study (baseline) and 12 weeks (last follow up visit).