Comparing Efficacy of Azithromycin and Probiotics for Treatment of Acne Vulgaris

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Comparing Efficacy of Azithromycin and Probiotics for Treatment of Acne Vulgaris

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: Azithromycin
* Drug: Probiotic Formula
* Drug: Benzoyl Peroxide 4 % Topical Cream


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Azithromycin and Topical<br>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<br>* antibiotic<br>* Other names: Zetro by Getz Pharma;Drug: Benzoyl Peroxide 4 % Topical Cream<br>* topical cream<br>* Other names: Benoxyl by Glitz pharma;|
| Experimental: Probiotics and Topical<br>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<br>* probiotics<br>* Other names: Hi-Flora by Unicare Bioceuticals;Drug: Benzoyl Peroxide 4 % Topical Cream<br>* topical cream<br>* Other names: Benoxyl by Glitz pharma;|
| Other: Azithromycin and Probiotics and Topical<br>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<br>* antibiotic<br>* Other names: Zetro by Getz Pharma;Drug: Probiotic Formula<br>* probiotics<br>* Other names: Hi-Flora by Unicare Bioceuticals;Drug: Benzoyl Peroxide 4 % Topical Cream<br>* topical cream<br>* Other names: Benoxyl by Glitz pharma;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). |