Comparison of Efficacy of Azithromycin Alone vs Combination of Azithromycin and Probiotics in Management of Mild to Moderate Acne Vulgaris

January 27, 2026 updated by: Naheed asghar, Hayatabad Medical Complex
The Goal of this Clinical trial is to compare the efficacy of oral azithromycin alone with combination therapy of oral azithromycin and probiotics to see is there any significant difference in outcome of two treatment modalities in mild to moderate acne vulgaris

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 4

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
      • Peshawar, Pakistan
        • Hayatabad Medical Complex

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

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria: Participants with mild to moderate acne on basis of global acne assessment scale score of 2 or 3 and with 20 to 50 total lesion count will be included.

-

Exclusion Criteria:

History of active localized or generalized infection History of autoimmune disease History of other facial skin diseases/ excessive facial hair or scars History of using isotretinoin or oral contraceptive pills in past 6 months History of already using antibiotics for acne treatment History of facial cosmetic procedures within last 3 months History of allergy to drugs used in study History of using drugs that may interact with azithromycin Currently pregnant or lactating women

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Oral Azithromycin group
The participants in this arm of study will receive only Oral Azithromycin to treat their Acne
Drug: Azithromycin 250 MG Oral Capsule
The participants in this arm of study will receive only Oral Azithromycin 250mg on alternate day for 12 weeks to treat their Acne
Active Comparator: Oral Azithromycin and Oral probiotic combination
The participants in this arm of study will receive both Oral Azithromycin and Oral Probiotics to treat their Acne
Drug: Azithromycin 250 MG Oral Capsule Along with Oral Probiotics
The participants in this arm of study will receive only Oral Azithromycin 250mg on alternate day along with oral probiotics daily for 12 weeks to treat their Acne

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction of Acne Lesion Count as per Acne Global assessment scale
Time Frame: 12 Weeks

The patients will be assessed before and after the treatment and their lesions will be counted .The Primary outcome that will be measured is the reduction of the lesion counts according to the Acne global Assessment scale

The participants included will be with mild to moderate acne on basis of global acne assessment scale score of 2 or 3.

The minimum Lesion count considered will be 20 and the Maximum will be 50.

Lower is better Higher is worse.
12 Weeks

Collaborators and Investigators

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

Sponsor

Hayatabad Medical Complex

Investigators

  • Study Chair: Ayesha Naeem, Hayatabad Medical Complex Peshawar, KPK Pakistan

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 12, 2025

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

January 27, 2026

First Submitted That Met QC Criteria

January 27, 2026

First Posted (Actual)

February 3, 2026

Study Record Updates

Last Update Posted (Actual)

February 3, 2026

Last Update Submitted That Met QC Criteria

January 27, 2026

Last Verified

October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HMC Peshawar

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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