Comparing Efficacy of Azithromycin and Probiotics for Treatment of Acne Vulgaris

November 30, 2022 updated by: Mushayada Irshad, Pak Emirates Military Hospital
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Rawalpindi, Punjab, Pakistan, 46000
        • PEMH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 31 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Azithromycin and Topical
group A (n=25) received tab. azithromycin 250mg oral on alternate days and topical cream benzoyl peroxide 4% twice a day daily for a period of 3 months
Drug: Azithromycin
antibiotic
Other Names:
  • "Zetro" by "Getz Pharma"
Drug: Benzoyl Peroxide 4 % Topical Cream
topical cream
Other Names:
  • "Benoxyl" by "Glitz pharma"
Experimental: Probiotics and Topical
group B (n=25) received Probiotic sachet oral once a day everyday and topical cream benzoyl peroxide 4% twice a day daily for a period of 3 months
Drug: Benzoyl Peroxide 4 % Topical Cream
topical cream
Other Names:
  • "Benoxyl" by "Glitz pharma"
Drug: Probiotic Formula
probiotics
Other Names:
  • "Hi-Flora" by "Unicare Bioceuticals"
Other: Azithromycin and Probiotics and Topical
combination group C (n=25) received tab. azithromycin 250mg oral on alternate days, Probiotic sachet oral once a day everyday and topical cream benzoyl peroxide 4% twice a day daily for a period of 3 months
Drug: Azithromycin
antibiotic
Other Names:
  • "Zetro" by "Getz Pharma"
Drug: Benzoyl Peroxide 4 % Topical Cream
topical cream
Other Names:
  • "Benoxyl" by "Glitz pharma"
Drug: Probiotic Formula
probiotics
Other Names:
  • "Hi-Flora" by "Unicare Bioceuticals"

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change or reduction in the Total Lesion Count
Time Frame: 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).
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
change or reduction in the Dermatology Life Quality Index score
Time Frame: at start of the study (baseline) and 12 weeks (last follow up visit).
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pak Emirates Military Hospital

Investigators

  • Study Director: Akbar W Syed, PhD, Riphah International University, Islamabad

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2021

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

August 31, 2022

Study Registration Dates

First Submitted

November 9, 2022

First Submitted That Met QC Criteria

November 17, 2022

First Posted (Actual)

November 29, 2022

Study Record Updates

Last Update Posted (Actual)

December 5, 2022

Last Update Submitted That Met QC Criteria

November 30, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A/28/EC/337/2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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