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

NCT07384793 | Active Not Recruiting Phase 4 DMC

• 1 other identifier: HMC Peshawar
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acne Vulgaris II or III Degree

Outcome Measures

Primary Outcomes (1)

• Reduction of Acne Lesion Count as per Acne Global assessment scale

  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

Study Arms (2)

Oral Azithromycin group

ACTIVE COMPARATOR

The participants in this arm of study will receive only Oral Azithromycin to treat their Acne

Drug: Azithromycin 250 MG Oral Capsule

Oral Azithromycin and Oral probiotic combination

ACTIVE COMPARATOR

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

Interventions

Azithromycin 250 MG Oral Capsule DRUG

The participants in this arm of study will receive only Oral Azithromycin 250mg on alternate day for 12 weeks to treat their Acne

Oral Azithromycin group

Azithromycin 250 MG Oral Capsule Along with Oral Probiotics DRUG

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

Oral Azithromycin and Oral probiotic combination

Eligibility Criteria

• Age: 15 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hayatabad Medical Complex: lead

Study Sites (1)

Hayatabad Medical Complex

Peshawar, Pakistan

Location

MeSH Terms

Interventions

Azithromycin; Probiotics

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Ayesha Naeem

  Hayatabad Medical Complex Peshawar, KPK Pakistan

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Dermatology unit HMC

Study Record Dates

• First Submitted: January 27, 2026
• First Posted: February 3, 2026
• Study Start: October 12, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: February 3, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)