Clincosm LogoSign in Get a demo

Comparing Efficacy of Azithromycin and Probiotics for Treatment of Acne Vulgaris

Sponsor
Pak Emirates Military Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05629468
Collaborator
(none)
75
Enrollment
1
Location
3
Arms
10.5
Actual Duration (Months)
7.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
75 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Comparing Efficacy of Azithromycin and Probiotics for Treatment of Acne Vulgaris
Actual Study Start Date :
Oct 15, 2021
Actual Primary Completion Date :
Jun 30, 2022
Actual Study Completion Date :
Aug 31, 2022

Arms and Interventions

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: Probiotic Formula
    probiotics
    Other Names:
  • "Hi-Flora" by "Unicare Bioceuticals"

    • Drug: Benzoyl Peroxide 4 % Topical Cream
    topical cream
    Other Names:
  • "Benoxyl" by "Glitz pharma"

    		•
    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: Probiotic Formula
    probiotics
    Other Names:
  • "Hi-Flora" by "Unicare Bioceuticals"

    • Drug: Benzoyl Peroxide 4 % Topical Cream
    topical cream
    Other Names:
  • "Benoxyl" by "Glitz pharma"

    		•

    Outcome Measures

    Primary Outcome Measures

    1. change or reduction in the Total Lesion Count [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

    Secondary Outcome Measures

    1. change or reduction in the Dermatology Life Quality Index score [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    15 Years to 35 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 PEMH Rawalpindi Punjab Pakistan 46000

    Sponsors and Collaborators

    • Pak Emirates Military Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mushayada Irshad, Prinicipal Investigator, Pak Emirates Military Hospital
    ClinicalTrials.gov Identifier:
    NCT05629468
    Other Study ID Numbers:
    • A/28/EC/337/2021
    First Posted:
    Nov 29, 2022
    Last Update Posted:
    Dec 5, 2022
    Last Verified:
    Nov 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Acne Vulgaris
    Azithromycin
    Benzoyl Peroxide

    Study Results

    No Results Posted as of Dec 5, 2022