Back to resultsComparing Efficacy of Azithromycin and Probiotics for Treatment of Acne Vulgaris
Primary Purpose
Acne Vulgaris
Status
Completed
Phase
Phase 3
Locations
Pakistan
Study Type
Interventional
Intervention
Azithromycin
Probiotic Formula
Benzoyl Peroxide 4 % Topical Cream
Sponsored by
About this trial
This is an interventional treatment trial for Acne Vulgaris
Eligibility Criteria
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
Sites / Locations
- PEMH
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Other
Arm Label
Azithromycin and Topical
Probiotics and Topical
Azithromycin and Probiotics and Topical
Arm Description
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 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
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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT05629468
First Posted
November 9, 2022
Last Updated
November 30, 2022
Sponsor
Pak Emirates Military Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05629468
Brief Title
Comparing Efficacy of Azithromycin and Probiotics for Treatment of Acne Vulgaris
Official Title
Comparing Efficacy of Azithromycin and Probiotics for Treatment of Acne Vulgaris
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
October 15, 2021 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
August 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pak Emirates Military Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Azithromycin and Topical
Arm Type
Active Comparator
Arm Description
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
Arm Title
Probiotics and Topical
Arm Type
Experimental
Arm Description
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
Arm Title
Azithromycin and Probiotics and Topical
Arm Type
Other
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Azithromycin
Other Intervention Name(s)
"Zetro" by "Getz Pharma"
Intervention Description
antibiotic
Intervention Type
Drug
Intervention Name(s)
Probiotic Formula
Other Intervention Name(s)
"Hi-Flora" by "Unicare Bioceuticals"
Intervention Description
probiotics
Intervention Type
Drug
Intervention Name(s)
Benzoyl Peroxide 4 % Topical Cream
Other Intervention Name(s)
"Benoxyl" by "Glitz pharma"
Intervention Description
topical cream
Primary Outcome Measure Information:
Title
change or reduction in the Total Lesion Count
Description
number of acne lesions are counted at every follow up to see whether lesions are reduced than the baseline or not
Time Frame
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 Measure Information:
Title
change or reduction in the Dermatology Life Quality Index score
Description
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.
Time Frame
at start of the study (baseline) and 12 weeks (last follow up visit).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Akbar W Syed, PhD
Organizational Affiliation
Riphah International University, Islamabad
Official's Role
Study Director
Facility Information:
Facility Name
PEMH
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
46000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparing Efficacy of Azithromycin and Probiotics for Treatment of Acne Vulgaris
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