Comparing Efficacy of Azithromycin and Probiotics for Treatment of Acne Vulgaris

NCT ID: NCT05629468

Last Updated: 2022-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-15

Study Completion Date

2022-08-31

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.

Conditions

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Acne Vulgaris

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Azithromycin

Intervention Type DRUG

antibiotic

Benzoyl Peroxide 4 % Topical Cream

Intervention Type DRUG

topical cream

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

Group Type EXPERIMENTAL

Probiotic Formula

Intervention Type DRUG

probiotics

Benzoyl Peroxide 4 % Topical Cream

Intervention Type DRUG

topical cream

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

Group Type OTHER

Azithromycin

Intervention Type DRUG

antibiotic

Probiotic Formula

Intervention Type DRUG

probiotics

Benzoyl Peroxide 4 % Topical Cream

Intervention Type DRUG

topical cream

Interventions

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Azithromycin

antibiotic

Intervention Type DRUG

Probiotic Formula

probiotics

Intervention Type DRUG

Benzoyl Peroxide 4 % Topical Cream

topical cream

Intervention Type DRUG

Other Intervention Names

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"Zetro" by "Getz Pharma" "Hi-Flora" by "Unicare Bioceuticals" "Benoxyl" by "Glitz pharma"

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
Minimum Eligible Age

15 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pak Emirates Military Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mushayada Irshad

Prinicipal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Akbar W Syed, PhD

Role: STUDY_DIRECTOR

Riphah International University, Islamabad

Locations

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PEMH

Rawalpindi, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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A/28/EC/337/2021

Identifier Type: -

Identifier Source: org_study_id

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