Comparing Efficacy of Azithromycin and Probiotics for Treatment of Acne Vulgaris
1 other identifier
interventional
75
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Oct 2021
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2022
CompletedFirst Submitted
Initial submission to the registry
November 9, 2022
CompletedFirst Posted
Study publicly available on registry
November 29, 2022
CompletedDecember 5, 2022
November 1, 2022
9 months
November 9, 2022
November 30, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
change or reduction in the Dermatology Life Quality Index score
at start of the study (baseline) and 12 weeks (last follow up visit).
Study Arms (3)
Azithromycin and Topical
ACTIVE COMPARATORgroup 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
Probiotics and Topical
EXPERIMENTALgroup 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
Azithromycin and Probiotics and Topical
OTHERcombination 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
Interventions
antibiotic
probiotics
topical cream
Eligibility Criteria
You may qualify if:
- Diagnosed Patients of Mild and Moderate acne
- Aged between 15 and 35 years
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
PEMH
Rawalpindi, Punjab Province, 46000, Pakistan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Akbar W Syed, PhD
Riphah International University, Islamabad
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prinicipal Investigator
Study Record Dates
First Submitted
November 9, 2022
First Posted
November 29, 2022
Study Start
October 15, 2021
Primary Completion
June 30, 2022
Study Completion
August 31, 2022
Last Updated
December 5, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share