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Completed

NCT Number: NCT05629468

Comparing Efficacy of Azithromycin and Probiotics for Treatment of Acne Vulgaris

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

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Key information

Conditions

Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

15 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

PEMH

Rawalpindi, Punjab Province, 46000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Azithromycin

Drug

antibiotic

Other names: "Zetro" by "Getz Pharma"

Probiotic Formula

Drug

probiotics

Other names: "Hi-Flora" by "Unicare Bioceuticals"

Benzoyl Peroxide 4 % Topical Cream

Drug

topical cream

Other names: "Benoxyl" by "Glitz pharma"

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Pak Emirates Military Hospital

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 29, 2022
Registry last updated
Dec 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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